ABSTRACT
Aim
To evaluate the effect of skin‐to‐skin contact during caesarean section on neonatal pain and stress during the first intramuscular injection.
Design
Prospective randomized controlled trial.
Methods
The study was conducted between January and July 2023 in an education and research hospital. Sixty healthy term newborns of women undergoing elective caesarean delivery under spinal anaesthesia were randomly allocated to skin‐to‐skin contact (n = 30) or routine care (n = 30). In the intervention group, standardized skin‐to‐skin contact was provided for approximately 3 min during caesarean section. Neonatal pain and stress were assessed using the Newborn Pain and Stress Assessment Scale (ALPS‐Neo) at four predefined timepoints.
Results
ALPS‐Neo scores were similar between groups at baseline but were lower in the skin‐to‐skin contact group immediately before, during, and after the first intramuscular injection. During the injection, the mean between‐group difference was −2.633 (95% CI: −3.135 to −2.132, p < 0.001), with a large standardized effect (Hedges' g = −2.68, 95% CI: −3.38 to −1.99).
Conclusion
Brief intraoperative skin‐to‐skin contact may reduce immediate neonatal pain and stress during the first intramuscular injection after caesarean birth.
Implications for the Profession and/or Patient Care
Skin‐to‐skin contact may provide a simple non‐pharmacological strategy to support neonatal comfort during routine painful procedures after caesarean birth when appropriate clinical and thermal conditions are ensured.
Impact
This study supports the analgesic and stress‐reducing effects of skin‐to‐skin contact and extends existing evidence to brief intraoperative contact during caesarean delivery. Repeated assessment showed that the between‐group difference was greatest during the painful procedure.
Reporting Method
The study was reported in accordance with the CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments.
No Patient or Public Contribution
There was no patient or public involvement in the design, management, interpretation, reporting, or dissemination of this study. Women and their newborns were involved solely as research participants, and written informed consent was obtained from the women before participation.
Trial and Protocol Registration
ClinicalTrials.gov (registration number: NCT05700552).
Keywords: caesarean delivery, newborn, pain, randomized controlled trial, skin‐to‐skin contact, stress
1. Introduction
Although skin‐to‐skin contact is widely recommended as a non‐pharmacological approach to support neonatal comfort, thermoregulation, pain control, and early breastfeeding, its application during caesarean section remains less consistent than after vaginal birth (Altit et al. 2024; Johnston et al. 2017; Moore et al. 2025). In the operating room, concerns related to hypothermia, surgical sterility, maternal positioning, anaesthesia‐related monitoring, and team coordination may delay or prevent early mother–newborn contact (Kollmann et al. 2017; Robertson 2013). Therefore, caesarean birth represents a distinct clinical context in which the feasibility and effects of early skin‐to‐skin contact require specific evaluation rather than direct extrapolation from vaginal birth studies.
Skin‐to‐skin contact may reduce neonatal pain and stress through several clinically relevant mechanisms. Direct maternal contact provides warmth, tactile containment, and sensory regulation, which may help stabilize autonomic responses and reduce behavioural signs of pain and stress in newborns (Altit et al. 2024; Campbell‐Yeo et al. 2025; Johnston et al. 2017). These effects are clinically reflected in outcomes such as lower pain scores, more stable heart and respiratory rates, and improved early breastfeeding behaviour (Beiranvand et al. 2014; Guala et al. 2017; Zhang, Wang, et al. 2023). These mechanisms are particularly relevant during the first intramuscular injection, which is commonly administered shortly after birth and represents one of the earliest painful procedures experienced by healthy newborns (Chaudhari 2021; Shah et al. 2023).
Previous studies have generally supported the beneficial effects of skin‐to‐skin contact on neonatal procedural pain. However, much of the available evidence comes from painful procedures conducted in broader neonatal or postnatal care settings (Campbell‐Yeo et al. 2025; Johnston et al. 2017; Shen et al. 2022). Studies of early skin‐to‐skin contact during caesarean delivery have mainly focused on neonatal adaptation, physiological stability, maternal outcomes, and early breastfeeding. Procedural pain during intramuscular injection has received less attention in this setting (Kollmann et al. 2017). In contrast, studies have examined skin‐to‐skin contact during neonatal intramuscular injection. These studies reported beneficial effects on pain and physiological responses. However, they were not specific to the intraoperative caesarean setting (Kaya and Zengin 2023; Sajedi et al. 2007). Neonatal pain and stress have not been consistently assessed at multiple procedural timepoints during brief intraoperative skin‐to‐skin contact. These timepoints include before, during, and after injection. Therefore, it remains unclear whether skin‐to‐skin contact initiated during caesarean delivery can reduce neonatal pain and stress during an immediate painful procedure.
Nurses and midwives have an important role in assessing neonatal pain and providing non‐pharmacological comfort measures (Campbell‐Yeo et al. 2025; Johnston et al. 2017). They are also directly involved in early newborn observation, thermal care, procedural preparation, pain assessment, and support of mother–newborn contact after caesarean birth. Therefore, evidence on feasible nursing interventions that can reduce neonatal pain and stress during routine procedures is clinically important. Skin‐to‐skin contact is one of the recommended approaches to support neonatal comfort, thermal stability, and early mother–newborn interaction (Altit et al. 2024; Moore et al. 2025). During caesarean birth, however, its implementation requires close thermal monitoring and coordination among the obstetric, anaesthesia, neonatal, and nursing teams (Caughey et al. 2026).
Previous research has largely examined skin‐to‐skin contact in postnatal or broader neonatal settings (Campbell‐Yeo et al. 2025; Johnston et al. 2017; Shen et al. 2022). Studies conducted during caesarean delivery have mainly focused on physiological adaptation, maternal outcomes, breastfeeding, or general neonatal stability (Kollmann et al. 2017; Moore et al. 2025; Zhang, Cooley, et al. 2023). Evidence remains limited on whether brief intraoperative skin‐to‐skin contact can be integrated into nursing and midwifery care to reduce neonatal pain and stress during an immediate painful procedure. Repeated assessment of neonatal pain and stress before, during, and after such a procedure is also limited in the nursing literature. This study addresses this gap by evaluating brief intraoperative skin‐to‐skin contact during caesarean delivery and examining neonatal pain and stress across the procedural period.
This randomized controlled trial evaluated the effect of brief, standardized skin‐to‐skin contact during caesarean section. The primary outcome was neonatal pain and stress during the first intramuscular injection. Secondary outcomes were neonatal vital signs, time to first breastfeeding, and duration of initial breastfeeding.
The hypotheses of the study were as follows:
Newborns who receive skin‐to‐skin contact during caesarean section have lower ALPS‐Neo pain and stress scores before, during, and after the first intramuscular injection than newborns who receive routine care.
Newborns who receive skin‐to‐skin contact during caesarean section have more favourable physiological responses during the early procedural period than newborns who receive routine care.
Newborns who receive skin‐to‐skin contact during caesarean section initiate breastfeeding earlier and have a longer initial breastfeeding duration than newborns who receive routine care.
2. Materials and Methods
2.1. Study Design
This study is a randomized controlled trial.
2.2. Setting
The study was conducted at an Education and Research Hospital in Darica Farabi. The hospital is a tertiary maternity care center and performs approximately 150 caesarean deliveries per month. Participant recruitment and data collection were conducted between January and July 2023. Eligible women were scheduled for elective caesarean delivery under spinal anaesthesia. They met the study criteria and agreed to participate. The intervention consisted of approximately 3 min of intraoperative skin‐to‐skin contact under routine operating‐room conditions.
2.3. Participants
The sample size was calculated using pain and stress scores reported by Todil and Çetinkaya. These outcomes were considered the closest to the primary outcome of the present study. In that study, the mean pain and stress score was 14.13 ± 4.26 in the kangaroo care group and 20.16 ± 4.21 in the control group, corresponding to an estimated standardized effect size of Cohen's d = 1.42. Based on this effect size, α = 0.05, power = 0.95, and a two‐tailed test, the minimum required sample size was calculated as 14 newborns per group using G*Power 3.1.9.2. To increase statistical precision and account for potential data loss, 30 newborns were included in each group (Faul et al. 2007; Todil and Cetinkaya 2022). Assignment of participants to groups was performed using a website (https://www.randomlists.com/). Participants were randomly assigned to the skin‐to‐skin contact group or the control group in a 1:1 allocation ratio using a computer‐generated random sequence created through http://randomlists.com/. Simple randomization was used, and no blocking or stratification was applied. The random allocation sequence was generated by Sena Dilek Aksoy before participant recruitment. Eligible participants were enrolled by Seda Yazıcı Yel after written informed consent was obtained. Seda Yazıcı Yel then assigned participants to the study groups according to the pre‐generated randomization list. Randomization and group assignment were completed before caesarean delivery. For participants allocated to the intervention group, skin‐to‐skin contact was initiated after birth and the initial neonatal assessment. The exact interval between group assignment and initiation of the intervention was not recorded. No formal allocation concealment procedure, such as sequentially numbered opaque sealed envelopes or central randomization, was used. This was acknowledged as a methodological limitation.
Because the reference effect size was large, the calculated sample size may have been insufficient to detect smaller true effects. Therefore, the sample size calculation should be interpreted in the context of the effect estimate available from the closest previous study.
2.3.1. Inclusion Criteria
Participants spoke and understood Turkish and were 18–45 years old. They had conceived naturally, had a singleton pregnancy at 37–42 weeks of gestation, and were scheduled for elective caesarean section under spinal anaesthesia. They had no hearing problems and agreed to participate in the study. Newborns had a first‐minute Apgar score of 7 or above, no congenital anomalies, no need for special monitoring or care, and a birth weight between 2500 and 4000 g.
2.3.2. Exclusion Criteria
Participants were excluded if they had insufficient mental capacity, a maternal chest temperature below 36.5°C, a high‐risk pregnancy, or any postpartum complication. High‐risk pregnancies included gestational hypertensive disorders, gestational diabetes, placental disorders, and venous embolism. Participants were also excluded if they refused Hepatitis B vaccination, Vitamin K, or any intramuscular injection for their newborn. Newborns were excluded if they had a body temperature below 36.5°C, were stillborn, required oxygen support, underwent painful procedures such as resuscitation or aspiration, or needed additional monitoring or care.
Women who conceived naturally were included to create a more homogeneous cohort. This also reduced potential confounding related to assisted reproductive technologies. High‐risk pregnancies were excluded because they may require additional obstetric or neonatal interventions and may affect newborn pain and stress responses. These criteria were used to strengthen internal validity and to support the safe and standardized application of skin‐to‐skin contact during caesarean section.
This study was conducted according to the CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments (Boutron et al. 2017) (Data S1). The research stages are presented in Figure 1.
FIGURE 1.
CONSORT‐NPT flow diagram outlining the execution and data collection process of the study (Boutron et al. 2017).
2.4. Data Collection Tools
2.4.1. Information Form
Prepared by the researchers within the framework of the literature. The form consisted of 10 questions querying the sociodemographic and obstetric information of women (Kollmann et al. 2017; Sajedi et al. 2007).
2.4.2. Neonatal Follow‐Up Form
This comprised 10 questions, including identifying characteristics of the newborn, measurements of vital signs, and time and duration of initial breastfeeding.
2.4.3. Neonatal Pain and Stress Assessment Scale (ALPS‐Neo)
This scale was developed by Lundqvist et al. (2014) to assess pain and stress in premature and term newborns. The scale consists of a single dimension and five items, including the newborn's facial expression, breathing pattern, extremity tone, and activity level, such as hand and foot activity, rated on a 3‐point Likert scale (0–1–2). Scores range from 0 to 10, with higher scores indicating increased pain and stress. The Turkish validity and reliability study of the ALPS‐Neo scale was conducted by Ceylan and Bolışık (2017).
Before data collection, the observer midwife received training on the use and scoring of the ALPS‐Neo scale. The observer also completed a practice assessment using a sample case before participant evaluation began. ALPS‐Neo scoring was performed in real time by a single observer. Therefore, inter‐rater and intra‐rater reliability were not assessed in this study.
2.5. Study Procedure
Ethical committee approval and institutional permission were obtained before the study. Information about the study was provided to eligible participants before the caesarean section and before initiation of the surgical procedure. The purpose of the study, study procedures, voluntary participation, and the right to withdraw from the study were explained. Participants who met the inclusion criteria and agreed to participate were asked to read and sign the written informed consent form.
This study did not implement a gentle or sensitive caesarean protocol. In such protocols, the unclothed newborn is passed directly over or under the surgical drape and placed immediately on the mother's bare chest. Instead, the intervention was adapted to the routine operating‐room conditions and newborn safety procedures of the study hospital. After birth, newborns were first assessed under a radiant heater for well‐being and Apgar scores. Initial drying, diapering, covering the head with a cap, and wrapping with pre‐warmed surgical drapes were then performed to reduce heat loss before skin‐to‐skin contact.
Newborns allocated to the skin‐to‐skin contact group received brief intraoperative skin‐to‐skin contact during caesarean section. Newborns in the control group received routine institutional care. Intramuscular injections in both groups were administered by Seda Yazıcı Yel. Neonatal pain and stress were assessed in real time by an independent observer midwife. The observer was not involved in randomization, group allocation, intervention delivery, routine newborn care, or injection administration. Another independent midwife assisted Seda Yazıcı Yel during the procedure.
2.5.1. Outcome Measurements
The primary outcome was the ALPS‐Neo pain and stress score measured during the first intramuscular injection. ALPS‐Neo scores were assessed at four measurement timepoints: Time 1, pre‐intervention baseline under the radiant warmer; Time 2, immediately before the first intramuscular injection; Time 3, during the first intramuscular injection; and Time 4, approximately 5 min after the first intramuscular injection. Secondary outcomes included neonatal vital signs, time to first breastfeeding, and duration of initial breastfeeding.
The trial registration initially listed ALPS‐Neo scores immediately before and after the intramuscular injection as the primary outcome timepoints. After the study began, the measurement plan was refined following the pilot study and expert review. The during‐injection measurement was then selected as the primary outcome because it directly captured the newborn's response to the painful stimulus. This decision was made before the final data analysis. However, the ClinicalTrials.gov record was not updated to reflect this change. The secondary outcomes reported in this study were also not specified in the original trial registration.
2.5.1.1. Procedure for the Skin‐to‐Skin Contact Group
After newborns were born by caesarean section, their well‐being and Apgar scores were assessed under a radiant heater.
Suitable newborns were dried with green cloths under the radiant heater, diapered, and their heads were covered with caps. The newborns were then wrapped in pre‐warmed surgical drapes.
The baseline ALPS‐Neo score was assessed and recorded under the radiant heater.
Before skin‐to‐skin contact began, a pre‐warmed surgical drape was placed on the mother's chest, and maternal chest temperature was measured with a thermometer.
If the maternal chest temperature was 36.5°C or higher, the newborn was brought to the mother and placed naked on her bare chest.
A heated surgical drape was placed over the newborn to reduce the risk of heat loss.
The ALPS‐Neo score was recorded before the first injection while skin‐to‐skin contact was being provided on the mother's chest.
Hepatitis B vaccine and Vitamin K were administered intramuscularly while the newborn was on the mother's chest. The ALPS‐Neo score was reassessed during administration. The first intramuscular injection was administered during the approximately 3‐min skin‐to‐skin contact period. Skin‐to‐skin contact was then ended under thermal precautions. Time 4 assessment was performed approximately 5 min after the injection.
To reduce the risk of hypothermia, skin‐to‐skin contact was maintained for approximately 3 min under thermal precautions.
The ALPS‐Neo score was assessed approximately 5 min after the intramuscular injection.
The newborn was then taken to the nursery for dressing, anthropometric measurements, and other routine examinations.
When the mother was transferred from the operating room to the delivery ward, the newborn was transferred with her. The time to first breastfeeding and the duration of breastfeeding were then recorded.
2.5.1.2. Procedure for the Control Group
In the control group, the routine institutional procedure was applied after caesarean section.
After birth, newborns' well‐being and Apgar scores were assessed under a radiant heater.
The baseline ALPS‐Neo score was assessed and recorded under radiant heating.
The newborn was wrapped in pre‐warmed operating‐room drapes and shown to the mother.
The newborn was then taken to the nursery for dressing, anthropometric measurements, and other routine examinations.
The ALPS‐Neo score was recorded before the first injection.
Hepatitis B vaccine and Vitamin K were administered intramuscularly in the nursery. The ALPS‐Neo score was reassessed during administration.
The ALPS‐Neo score was assessed approximately 5 min after the intramuscular injection.
These procedures and the transfer took approximately 30–45 min. After the routine procedures and examination were completed, the newborns were transferred to their room in the maternity ward.
As part of routine hospital practice, transfer and maternal stabilization procedures were completed before breastfeeding was initiated. The time to first breastfeeding was recorded for each newborn.
The time of mother–newborn skin‐to‐skin contact, time to first breastfeeding, and duration of breastfeeding were evaluated and recorded.
3. Statistical Analysis
Data analysis was performed using IBM SPSS Statistics 25.0 software (IBM Corp., Armonk, NY, USA). All randomized participants were included in the analysis according to the intention‐to‐treat principle. Descriptive statistics were used to summarize sociodemographic, obstetric, and neonatal characteristics. Between‐group comparisons of continuous variables were performed using independent‐samples t‐tests. Categorical variables were compared using the chi‐squared test or Fisher's exact test, as appropriate. ALPS‐Neo scores measured at four timepoints were analysed using a two‐way mixed ANOVA, with time as the within‐subject factor and group as the between‐subject factor. Although the individual ALPS‐Neo items are ordinal, the analysis was based on the summed ALPS‐Neo score, which ranges from 0 to 10 and has 11 possible score values. The summed score was treated as an approximately continuous outcome for the repeated‐measures analysis. The balanced group design and the relative robustness of mixed ANOVA to moderate departures from normality supported this analytical approach. This model was used to account for the correlated structure of repeated measurements within the same newborn. The group × time interaction was examined to determine whether changes in ALPS‐Neo scores over time differed between the groups. When the sphericity assumption was violated, Greenhouse–Geisser corrected degrees of freedom were reported (Greenhouse and Geisser 1959). Following a significant group × time interaction, between‐group comparisons at individual timepoints were performed using estimated marginal means. Because only two groups were compared at each timepoint, no additional multiplicity adjustment was applied to these pairwise comparisons. For the primary outcome, the standardized between‐group effect size was calculated using Hedges' g with a 95% confidence interval. No interim analyses or stopping guidelines were planned for this study. Statistical significance was set at p < 0.05.
4. Results
The maternal and neonatal baseline characteristics of the participants are presented in Table 1. No statistically significant between‐group differences were observed in these characteristics (p > 0.05). Before the procedure, respiratory rate was significantly higher in the control group than in the skin‐to‐skin contact group (49.20 ± 2.07 vs. 47.80 ± 1.98, p = 0.010). The findings related to the vital measurements of the newborns in the study are presented in Table 2. No statistically significant difference was observed between the body temperatures, pre‐procedure pulse rates, and saturation values of the newborns in the skin‐to‐skin contact and control groups (p > 0.05). However, a statistically significant difference was observed between the skin‐to‐skin contact and control groups in the following measurements: pulse rate during the procedure, post‐procedure pulse rate, pre‐procedure respiratory rate, respiratory rate during the procedure, and post‐procedure respiratory rate (p < 0.05).
TABLE 1.
Maternal and neonatal baseline characteristics of participants (n = 60).
| Characteristics | Skin‐to‐skin contact (n = 30) | Control (n = 30) | Total | t test/p |
|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Mean ± SD | ||
| Age | 28.03 ± 4.84 | 28.33 ± 5.39 | 28.18 ± 5.08 |
t = 0.227 p = 0.821 |
| Marriage age | 21.56 ± 3.27 | 20.03 ± 3.03 | 20.80 ± 3.22 |
t = 1.881 p = 0.065 |
| Gestational age | 39.03 ± 1.18 | 38.70 ± 1.02 | 38.86 ± 1.11 |
t = 1.165 p = 0.249 |
| Birth weight | 3265.83 ± 336.45 | 3278.67 ± 367.98 | 3272.25 ± 349.63 |
t = 0.141 p = 0.888 |
| First‐minute Apgar score | 8.97 ± 0.18 | 9.00 ± 0.00 | 8.98 ± 0.13 |
t = −1.000 p = 0.321 |
| n | % | n | % | n | % | χ 2/p | |
|---|---|---|---|---|---|---|---|
| Marital status | |||||||
| Married | 28 | 93.3 | 28 | 93.3 | 56 | 93.3 |
χ 2 = 0.000 a p = 1.000 |
| Single | 2 | 6.7 | 2 | 6.7 | 4 | 6.7 | |
| Employment status | |||||||
| Not working | 25 | 83.3 | 25 | 83.3 | 50 | 83.3 |
χ 2 = 0.000 b p = 1.000 |
| Working | 5 | 16.7 | 5 | 16.7 | 10 | 16.7 | |
| Education level | |||||||
| Primary education | 9 | 30.0 | 12 | 40.0 | 21 | 35.0 |
χ 2 = 1.799 b p = 0.407 |
| Secondary education | 13 | 43.3 | 14 | 46.7 | 27 | 45.0 | |
| University | 8 | 26.7 | 4 | 13.3 | 12 | 20.0 | |
| Income level | |||||||
| Good | 7 | 23.3 | 5 | 16.7 | 12 | 20.0 |
χ 2 = 0.417 b p = 0.519 |
| Medium | 23 | 76.7 | 25 | 83.3 | 48 | 80.0 | |
| Family type | |||||||
| Nuclear family | 15 | 50.0 | 12 | 40.0 | 27 | 45.0 |
χ 2 = 0.606 b p = 0.436 |
| Extended family | 15 | 50.0 | 18 | 60.0 | 33 | 55.0 | |
| Place of residence | |||||||
| Rural area | 9 | 30.0 | 7 | 23.3 | 16 | 26.7 |
χ 2 = 0.341 b p = 0.559 |
| Urban area | 21 | 70.0 | 23 | 76.7 | 44 | 73.3 | |
| Cigarette use | |||||||
| Yes | 6 | 20.0 | 8 | 26.7 | 14 | 23.3 |
χ 2 = 0.373 b p = 0.542 |
| No | 24 | 80.0 | 22 | 73.3 | 46 | 76.7 | |
| Sex | |||||||
| Female | 13 | 43.4 | 18 | 60.0 | 31 | 51.7 |
χ 2 = 1.669 b p = 0.196 |
| Male | 17 | 56.6 | 12 | 40.0 | 29 | 48.3 | |
Note: p < 0.05 statistical significance.
Abbreviations: SD, standard deviation; t, ındependent groups t‐test.
χ 2: Fisher's exact chi‐squared.
χ 2: Pearson chi‐squared.
TABLE 2.
Outcomes related to neonatal vital signs (n = 60).
| Characteristics | Skin‐to‐skin contact (n = 30) | Control (n = 30) | Total | t test/p |
|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Mean ± SD | ||
| Baseline neonatal body temperature | 36.55 ± 0.06 | 36.54 ± 0.08 | 36.55 ± 0.07 |
t = 0.343 p = 0.733 |
| Neonatal pulse rate before the procedure | 134.46 ± 5.84 | 136.70 ± 5.91 | 135.58 ± 5.93 |
t = −1.472 p = 0.147 |
| Neonatal pulse rate during the procedure | 139.13 ± 5.72 | 153.46 ± 5.27 | 146.30 ± 9.05 |
t = −10.086 p < 0.001 |
| Neonatal pulse rate after the procedure | 134.46 ± 6.04 | 145.06 ± 4.77 | 139.76 ± 7.60 |
t = −7.531 p < 0.001 |
| Respiratory rate before the procedure | 47.80 ± 1.98 | 49.20 ± 2.07 | 48.50 ± 2.13 |
t = −2.668 p = 0.010 |
| Respiratory rate during the procedure | 51.13 ± 1.71 | 57.43 ± 2.12 | 54.28 ± 3.71 |
t = −12.619 p < 0.001 |
| Respiratory rate after the procedure | 48.53 ± 1.96 | 51.26 ± 1.77 | 49.90 ± 2.31 |
t = −5.654 p < 0.001 |
| Newborn saturation | 99.13 ± 0.77 | 98.87 ± 0.81 | 99.00 ± 0.80 |
t = 1.294 p = 0.201 |
Note: Bold value: p < 0.001, p < 0.05 statistical significance.
Abbreviations: SD, standard deviation; t, independent groups t‐test.
The pain and stress scores of the newborns in the skin‐to‐skin contact and control groups during intramuscular injections were compared using the ALPS‐Neo scale (Table 3). Following the significant group × time interaction, simple‐effects comparisons based on estimated marginal means were performed at each timepoint. There was no significant between‐group difference at the pre‐intervention measurement (mean difference = −0.233, 95% CI: −0.595 to 0.129, p = 0.202). ALPS‐Neo scores were significantly lower in the skin‐to‐skin contact group before the first injection (mean difference = −0.733, 95% CI: −1.240 to −0.227, p = 0.005), during the first injection (mean difference = −2.633, 95% CI: −3.135 to −2.132, p < 0.001), and after the injection (mean difference = −1.933, 95% CI: −2.316 to −1.550, p < 0.001) (Table 3). For the primary outcome measured during the first intramuscular injection, the standardized between‐group effect was large (Hedges' g = −2.68, 95% CI: −3.38 to −1.99). These findings supported Ha.
TABLE 3.
Comparison of ALPS‐Neo scores between groups across measurement timepoints (n = 60).
| Timepoint | Skin‐to‐skin contact (n = 30) | Control (n = 30) | Mean difference (95% CI) | p |
|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Mean ± SD | ||
| Pre‐Intervention (under radiant heater) | 2.13 ± 0.68 | 2.37 ± 0.72 | −0.233 (−0.595 to 0.129) | p = 0.202 |
| Before the first injection | 1.57 ± 1.14 | 2.30 ± 0.79 | −0.733 (−1.240 to −0.227) | p = 0.005 |
| During the first injection (primary outcome) | 1.77 ± 0.77 | 4.40 ± 1.13 | −2.633 (−3.135 to −2.132) | p < 0.001 |
| After the first injection | 1.07 ± 0.25 | 3.00 ± 1.02 | −1.933 (−2.316 to −1.550) | p < 0.001 |
Note: Mean differences and 95% confidence intervals are based on estimated marginal means from the two‐way mixed ANOVA. Between‐group comparisons at each timepoint were examined as simple effects following the significant group × time interaction. Bold values indicate statistical significance at p < 0.05.
Abbreviations: CI, confidence interval; SD, standard deviation.
The findings related to breastfeeding data for the newborns in the study are presented in Table 4. A statistically significant difference was found in the time taken to initiate the first breastfeeding after birth (t = 2.894, p = 0.005) and in the duration of breastfeeding between the skin‐to‐skin contact and control groups (t = 9.277, p < 0.001).
TABLE 4.
Findings related to assessment of neonatal breastfeeding data (n = 60).
| Characteristics | Skin‐to‐skin contact (n = 30) | Control (n = 30) | Total | t test/p |
|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Mean ± SD | ||
| Time from birth to first breastfeeding (min) | 48.00 ± 5.35 | 51.67 ± 4.42 | 49.83 ± 5.20 |
t = −2.894 p = 0.005 |
| Initial breastfeeding duration (min) | 23.17 ± 5.33 | 11.83 ± 4.04 | 17.50 ± 7.39 |
t = 9.277 p < 0.001 |
Note: Bold value: p < 0.001, p < 0.05 statistical significance.
Abbreviations: SD, standard deviation; t, t‐test for independent groups.
A two‐way mixed ANOVA was conducted to examine the effects of group, time, and the group × time interaction on ALPS‐Neo scores. Because the sphericity assumption was violated, Greenhouse–Geisser corrected results were reported. The analysis showed a significant main effect of group, F(1, 58) = 64.445, p < 0.001, partial η 2 = 0.526, and a significant main effect of time, F(1.674, 97.088) = 42.421, p < 0.001, partial η 2 = 0.422. In addition, the group × time interaction was statistically significant, F(1.674, 97.088) = 46.737, p < 0.001, partial η 2 = 0.446. These findings indicate that changes in ALPS‐Neo scores over time differed significantly between the skin‐to‐skin contact and control groups (Table 5).
TABLE 5.
Two‐way mixed ANOVA results for ALPS‐Neo scores in the skin‐to‐skin contact and control groups (n = 60).
| Source | Sum of squares | df | Mean square | F | p | Partial η2 |
|---|---|---|---|---|---|---|
| Between‐subjects effects | ||||||
| Group | 114.817 | 1 | 114.817 | 64.445 | < 0.001 | 0.526 |
| Error | 103.333 | 58 | 1.782 | — | — | — |
| Within‐subjects effects | ||||||
| Time a | 49.150 | 1.674 | 29.362 | 42.421 | < 0.001 | 0.422 |
| Time × Group a | 54.150 | 1.674 | 32.349 | 46.737 | < 0.001 | 0.446 |
| Error (Time) a | 67.200 | 97.088 | 0.692 | — | — | — |
Note: Two‐way mixed ANOVA was performed with time as the within‐subject factor and group as the between‐subject factor.
Abbreviations: —, statistic was not applicable or not calculated for the corresponding error term; partial η 2, partial eta squared.
Greenhouse–Geisser corrected degrees of freedom are reported because the sphericity assumption was violated (Mauchly's W = 0.301, χ 2(5) = 68.092, p < 0.001; ε = 0.558).
As shown in Figure 2, ALPS‐Neo scores changed differently across the four predefined timepoints in the skin‐to‐skin contact and control groups. Scores were similar between groups at the pre‐intervention baseline, but subsequently followed different patterns. ALPS‐Neo scores remained lower in the skin‐to‐skin contact group before, during, and after the first intramuscular injection, whereas scores increased markedly during the injection in the control group. This pattern was consistent with the significant group × time interaction.
FIGURE 2.
Time‐dependent ALPS‐Neo score changes in the groups. Time 1: pre‐intervention baseline under the radiant warmer; Time 2: immediately before the first intramuscular injection; Time 3: during the first intramuscular injection; Time 4: approximately 5 min after the first intramuscular injection.
4.1. Harms and Adverse Events
No adverse events related to the intervention were observed during the study. No episodes of clinically apparent desaturation, interruption of the skin‐to‐skin contact procedure, or contamination of the surgical field were recorded. Post‐intervention neonatal body temperature was not measured; therefore, post‐intervention hypothermia could not be evaluated.
5. Discussion
Mother–newborn bonding is best supported by skin‐to‐skin contact initiated as early as possible after birth. However, medical needs and institutional conditions may delay or prevent this contact. These conditions include operating‐room procedures, team coordination, and maternal or newborn safety. Skin‐to‐skin contact is more commonly used after vaginal birth and is less frequently applied after caesarean delivery because of concerns about neonatal hypothermia (Kollmann et al. 2017). Recommendations have been developed to improve the feasibility of skin‐to‐skin contact during caesarean section. The Pan American Health Organization has also promoted this practice in caesarean care (Robertson 2013). Current evidence suggests that early skin‐to‐skin contact may benefit maternal and neonatal outcomes when appropriate thermal precautions are used. These benefits may also include improved lactation outcomes (Moore et al. 2025).
This study was conducted to examine the effect of skin‐to‐skin contact during caesarean section on pain and stress caused by the first intramuscular injection in newborns. Participants were randomized and assigned to groups. The similarity in demographic characteristics of the mothers and newborns supports the interpretation of the observed differences in relation to the intervention. In our study, the skin‐to‐skin contact group had lower pain and stress scores during and after the first intramuscular injection compared with the control group. These differences were statistically significant. The use of ALPS‐Neo for pain and stress assessment is also important. Studies have reported that ALPS‐Neo is effective in distinguishing procedural pain and provides acceptable reliability and validity for clinical use (Lundqvist et al. 2014; Vederhus et al. 2023). Because group allocation was visually apparent to the observer, detection bias cannot be excluded when interpreting the ALPS‐Neo findings.
Beyond statistical significance, the magnitude and clinical meaning of the observed differences should be emphasized. During the first intramuscular injection, the mean ALPS‐Neo score was 1.77 in the skin‐to‐skin contact group and 4.40 in the control group, indicating an approximately 2.6‐point reduction on a 0–10 scale. Similarly, after the injection, the difference between groups remained evident, with lower scores in the skin‐to‐skin contact group. This pattern suggests that skin‐to‐skin contact did not merely produce a transient pre‐procedural calming effect. It may also have attenuated the newborn's pain and stress response during the painful stimulus and immediately afterward. This interpretation is consistent with previous evidence indicating that skin‐to‐skin contact can reduce neonatal procedural pain and stress responses (Campbell‐Yeo et al. 2025; Johnston et al. 2017; Kaya and Zengin 2023). The large observed effect size indicates a substantial between‐group difference. However, its magnitude should be interpreted cautiously because the outcome was assessed by a single unblinded observer and the groups differed in postnatal timing and procedural environment. Therefore, the findings may have potential clinical relevance for early neonatal comfort during routine painful procedures after caesarean birth. However, this interpretation should remain cautious given the measurement and procedural limitations of the study. However, the primary outcome should also be interpreted in the context of differences in postnatal timing and procedural environment between the groups. In the skin‐to‐skin contact group, the injection was administered while the newborn was on the mother's chest. In the control group, the injection was administered later during routine nursery care. Therefore, the observed difference in ALPS‐Neo scores may reflect not only the effect of skin‐to‐skin contact but also differences in maternal proximity, postnatal age, and procedural environment. These factors could not be separated in the present study.
The clinical interpretation of the physiological findings also requires caution. Newborns in the skin‐to‐skin contact group had lower pulse and respiratory rates during and after the procedure than those in the control group. These findings were consistent with the lower ALPS‐Neo scores observed in this group. However, these differences may have been influenced not only by skin‐to‐skin contact itself but also by differences in the procedural environment and care pathway. In the intervention group, injections were administered while the newborn was on the mother's chest. In the control group, injections were administered during routine nursery care after separation from the mother. Therefore, the differences in vital signs may reflect the combined effects of brief skin‐to‐skin contact, maternal proximity, and the different procedural context. They should not be interpreted as an isolated physiological effect of skin‐to‐skin contact alone.
The breastfeeding‐related findings should be interpreted cautiously. In the present study, the shorter time to first breastfeeding and longer initial sucking duration in the skin‐to‐skin contact group may partly reflect the intervention itself. However, these outcomes may also have been influenced by differences in the care pathway. Newborns in the control group were separated from their mothers for routine nursery procedures and transfer. These differences in the care pathway may have influenced the timing of breastfeeding. Therefore, these breastfeeding outcomes should not be interpreted as an independent effect of skin‐to‐skin contact alone. Rather, these findings suggest a potential benefit of an early mother–newborn contact pathway during caesarean birth. Brief intraoperative skin‐to‐skin contact was associated with a modestly earlier initiation of breastfeeding in this study.
Previous studies have generally supported the beneficial effect of skin‐to‐skin contact on neonatal procedural pain. Sajedi et al. (2007) reported lower pain responses in term newborns who received skin‐to‐skin contact during an intramuscular injection. They also reported lower heart rates in these newborns (Sajedi et al. 2007). Similarly, Kinaci and Arslan (2021) found beneficial effects of skin‐to‐skin contact on pain and stress responses during heel lance in term newborns (Kinaci and Arslan 2021). Evidence syntheses have also supported skin‐to‐skin contact as a non‐pharmacological intervention for neonatal procedural pain (Johnston et al. 2017; Shen et al. 2022). More recently, Kaya and Zengin (2023) reported that postpartum skin‐to‐skin contact reduced pain associated with the first intramuscular injection in term newborns delivered vaginally (Kaya and Zengin 2023). These findings are consistent with the present results and support the analgesic effect of skin‐to‐skin contact during painful neonatal procedures. The present study extends this evidence by evaluating brief skin‐to‐skin contact initiated during caesarean delivery. It also assessed neonatal pain and stress before, during, and after the first intramuscular injection. The significant group × time interaction showed that the between‐group difference changed across the procedural period and was greatest during the injection.
Newborns are more sensitive to pain than adults. Stress can increase the experience of pain in newborns. These findings increase the clinical importance of pain and stress. Researchers have reported that exposure to painful procedures can increase sensitivity. Therefore, early identification of pain in newborns should be a fundamental goal of care. Pain should also be reduced using the least invasive and most effective methods possible (Olsson et al. 2021). Non‐pharmacological methods such as SSC can be used to manage acute procedural pain in newborns. These methods should be considered an important clinical approach (Altit et al. 2024; Campbell‐Yeo et al. 2025).
Hypothermia is one of the most important concerns for newborns in the operating room environment. It is reported that newborns, lacking a shivering mechanism and prone to heat loss, may experience a rapid drop in body temperature (Singer 2021; Singer et al. 2020). In our study, no difference was found in newborn body temperature between the SSC and control groups. Hypothermia is an important concern for newborns in the operating‐room environment. In the present study, neonatal body temperature was recorded as part of the eligibility and baseline assessment. No between‐group difference was observed in these recorded temperatures. However, body temperature was not reassessed after the skin‐to‐skin contact period. Therefore, the present study cannot determine whether intraoperative skin‐to‐skin contact affects the risk of post‐intervention hypothermia. ERAC recommendations also emphasize that thermal comfort in the operating room can significantly contribute to maternal recovery after caesarean section (Bollag and Nelson 2020; Hochstätter et al. 2023). Maternal recovery can indirectly contribute to newborn comfort, primarily by facilitating breastfeeding (Moore et al. 2025). Although operating rooms may feel cold, the ERAC/ERAS approach recommends maintaining the room temperature at approximately 23°C or higher. Active warming methods may also be used when needed to support maternal comfort and normothermia (Caughey et al. 2026; Na 2025). Current studies and recommendations report that heated or actively heated surgical conditions improve maternal thermal comfort and core temperature. However, there is no evidence that these conditions increase the risk of complications. This has been assessed using indicators related to the surgical field, such as wound temperature (Caughey et al. 2026; Kholeif et al. 2024; Talhaoğlu et al. 2024). Therefore, it may be beneficial to transition from traditional cold operating room environments to operating room environments that improve maternal and neonatal comfort.
Overall, the present findings extend existing evidence. They suggest that brief intraoperative SSC may reduce immediate neonatal pain and stress during the first intramuscular injection after caesarean birth. Further multicenter studies are needed to confirm these findings. They are also needed to evaluate the applicability of the findings across different caesarean care settings.
5.1. Strengths and Limitations
This study is one of the few randomized controlled trials examining the effect of skin‐to‐skin contact during caesarean delivery on neonatal pain and stress. The use of ALPS‐Neo strengthened the assessment process.
Several limitations should be considered. The primary outcome was assessed in real time by a single observer who could not be blinded to group allocation, which may have introduced detection bias. Blinding of the mother and clinical team was not possible, which may have introduced performance bias. Residual confounding from unmeasured factors cannot be excluded. The intervention lasted approximately 3 min; therefore, the findings mainly reflect immediate effects. The single‐center design and inclusion of low‐risk women with healthy term newborns also limit generalizability. Breastfeeding outcomes and some physiological measurements may have been influenced by differences in the care pathway between groups. A significant between‐group difference was present in pre‐procedure respiratory rate. This baseline imbalance should be considered when interpreting the physiological findings. The primary outcome was also measured at different postnatal ages and in different procedural environments between the groups. These differences may have influenced ALPS‐Neo scores independently of the skin‐to‐skin contact intervention. Therefore, the observed between‐group effect should be interpreted cautiously. In addition, no formal allocation concealment procedure was used. Finally, although the summed ALPS‐Neo score was treated as an approximately continuous outcome in the mixed ANOVA, its underlying items are ordinal. This analytical assumption should be considered when interpreting the findings. The sample size calculation was based on a large effect size from the closest available previous study. Therefore, the study may have had limited power to detect smaller true effects.
6. Conclusions
In this randomized controlled trial, newborns who received brief skin‐to‐skin contact during caesarean section had lower pain and stress scores during and after the first intramuscular injection. These scores were lower than those of newborns who received routine care. The skin‐to‐skin contact group also had lower pulse and respiratory rates during some early measurements. A small between‐group difference was observed in the time to first breastfeeding, while initial breastfeeding duration was longer in the skin‐to‐skin contact group. These secondary findings should be interpreted cautiously because they may have been influenced by differences in the care pathway. However, these secondary outcomes may have been influenced by differences in the care pathway and should be interpreted cautiously. No difference was observed between the groups in baseline neonatal body temperature.
These findings suggest that brief intraoperative skin‐to‐skin contact may be a feasible and potentially beneficial approach. It may reduce immediate neonatal pain and stress responses during routine painful procedures after caesarean birth. Appropriate thermal precautions and suitable clinical conditions should be ensured. However, this was a single‐center study involving selected low‐risk women and healthy term newborns. Therefore, the results should be interpreted cautiously. They should not be generalized to all caesarean births or high‐risk neonatal populations. Further multicenter studies with larger and more diverse samples are needed to confirm these findings and to evaluate longer‐term maternal and neonatal outcomes.
6.1. Implications for Nursing & Health Policy
Nurses and midwives should routinely assess neonatal pain and stress before, during, and after painful procedures using an appropriate neonatal pain assessment tool.
For clinically stable mothers and healthy term newborns, brief intraoperative skin‐to‐skin contact may be considered during early painful procedures after caesarean birth. The timing of procedures such as intramuscular injections may be coordinated with skin‐to‐skin contact when clinical conditions permit.
Before initiating skin‐to‐skin contact, maternal and neonatal clinical stability should be confirmed. Thermal precautions should be maintained, and the newborn should be closely observed throughout the contact period.
Nurses and midwives should document neonatal pain and stress responses and communicate any signs of instability promptly to the obstetric, anaesthesia, and neonatal teams.
Institutions considering intraoperative skin‐to‐skin contact should develop clear protocols defining eligibility criteria, thermal precautions, team responsibilities, monitoring requirements, and conditions for discontinuing the contact.
Because this was a single‐center study involving low‐risk women and healthy term newborns, routine implementation across all caesarean settings should await confirmation from larger multicenter studies.
Author Contributions
Seda Yazici Yel: conceptualization, methodology, data curation, software, investigation, validation, formal analysis, resources, funding acquisition, writing – original draft, writing – review and editing. Sena Dilek Aksoy: conceptualization, methodology, software, project administration, visualization, writing – original draft, writing – review and editing, formal analysis, validation, supervision.
Funding
The authors have nothing to report.
Disclosure
The authors affirm that the statistical methods used in this study were appropriate for the study design and data structure. The statistical analyses were conducted and interpreted correctly, and the authors take responsibility for the appropriateness and accuracy of the statistical analyses reported in the manuscript.
Ethics Statement
Consent was obtained from the institution where the research was conducted and from the participants. Approval was obtained from the Clinical Research Ethics Committee of Kocaeli University (approval number: KAEK/19.bI.03). The study was registered at ClinicalTrials.gov (registration number: NCT05700552). Permission to use the measurement device (ALPS‐Neo) was obtained via an email from the author. Written and verbal consent was obtained from all participants. The tenets of the Declaration of Helsinki were adhered to at all stages of the study.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: 2017 CONSORT checklist for randomized trials assessing nonpharmacologic treatments (NPTs).
Acknowledgements
The authors acknowledge the support of the Kocaeli University Scientific Research Projects Coordination Unit for the project entitled “The Effect of Maternal Body Temperature Level After Cesarean Section on Postoperative Maternal and Neonatal Outcomes: A Cross‐Sectional Study” (project no: TSA‐2021‐2692). Findings from this project contributed to the scientific rationale and planning of the present randomized controlled trial. The authors also acknowledge the Kocaeli University Institute of Health Sciences for its institutional support during the research process.
Declaration of AI use: During the preparation of this study, the authors utilized artificial intelligence (AI) tools for translation from Turkish to English, language editing. After using these tools, the authors reviewed and edited the content as needed and are fully responsible for the content of the publication.
Data Availability Statement
The datasets analysed during the current study are available from the corresponding author upon request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1: 2017 CONSORT checklist for randomized trials assessing nonpharmacologic treatments (NPTs).
Data Availability Statement
The datasets analysed during the current study are available from the corresponding author upon request.