A randomized controlled trial on the effectiveness of peanut ball device during labor on maternal outcomes and stress levels

Abstract

BACKGROUND:

Prolonged labor increases the risk of complications such as pain and stress affecting the maternal outcome. This study explores the impact of peanut on the labor process in reducing the labor pain, stress levels, and the need for assisted or cesaerean deliveries, and promotes a noninvasive approach to combat labor outcomes by evaluating its impact on maternal well-being.

MATERIALS AND METHODS:

This block randomized controlled trial was carried out in the labor unit of a tertiary care hospital, involving, “768 low-risk primigravid women,” who were randomly divided into two groups: the experimental group (n = 384) utilized peanut balls during labor when cervical dilatation reached 3–4 cm, and the control group (n = 384) received the standard care. The primary outcomes measured were the duration of 1^st and 2^nd stages of labor and the mode of delivery, while secondary outcomes focused on the pain perception and stress levels.

RESULTS:

This study revealed a substantial reduction in the duration of the active first stage of labor in the experimental arm (mean difference = −105.934 min) compared with the control arm (mean difference = −27.380 min). Moreover, a greater percentage of low-risk primigravid women in the experimental arm experienced normal vaginal delivery (84.9%) than those of control arm (68.8%). The participants in the experimental arm also reported significantly lower levels of pain and maternal stress than those of control arm.

CONCLUSION:

Employing the peanut ball device in labor resulted in notable benefits for the mother. So, educating expectant mothers about this non-invasive method can improve their health and comfort during labor. This approach encourages safer and more efficient delivery methods, thereby enhancing overall maternal care.

Introduction

Childbirth is a complex experience that involves physical, psychological, emotional, and social elements, as emphasized by Power et al.[1] These factors, combined with obstetric variables, significantly influence the well-being of the expectant mothers, as well as newborns.

Scholars have noted that prolonged labor, pain, and maternal stress pose challenges to safe childbirth.[2,3,4] For example, researchers reported a newborn Apgar score less than seven among nulliparous women, whose second stage of labor exceeded 4 hours.[5] In addition, a prolonged second stage of labor is positively correlated with neonatal infections, increased neonatal intensive care unit admissions, and intensive labor pain.

From the socioeconomic perspective, an inequity is observed in access to pain relief measures, among pregnant women across high- and low-income countries.[6] When 80 percent of pregnant women across higher-income countries receive pain relief intervention, only 10 percent have access to pain relief methods across lower-middle-income countries. Likewise, severe labor pain is also associated with post-partum depression,[7] which is higher across low-middle-income-countries (LMIC) than higher income countries.[8] To mitigate these challenges, researchers have assessed various pharmacological and non-pharmacological interventions to enhance the outcomes for both mothers and infants.[9,10,11,12,13]

Pharmacological methods such as the use of epidural anesthesia and a combination of propranolol and misoprostol have been found to be effective in reducing labor pain and duration of labor.[14,15] Despite their effectiveness, pharmacological interventions report adverse effects,[16] and remain unaffordable, among pregnant mothers in LMICs.[6,8] Therefore, researchers have endorsed the application of affordable non-pharmacological methods such as exercises, use of birthing balls, peanut balls, and Swiss balls to improve maternal and neonatal outcomes.[6,17,18] However, the evidence remains debatable due to a smaller sample size and methodological limitations.[6,7] Hence, we aimed to explore the efficacy of the peanut ball intervention in reducing maternal outcomes such as labor duration, pain, maternal stress, and mode of delivery.

A significant number of randomized controlled trials (RCTs) provide evidence for the effectiveness of the peanut ball intervention in decreasing labor duration, alleviating pain, affecting the mode of delivery, reducing postpartum hemorrhage, and influencing newborn APGAR (Appearance (skin color), P – Pulse (heart rate), G – Grimace (reflex irritability), A – Activity (muscle tone), R – Respiration (breathing effort) scores. Research has demonstrated favorable results in these aspects.[6,17,18] However, conflicting findings have also been documented; for instance, the 2018 research conducted by Mercier and Kwan revealed non-significant reduction of labor duration after peanut ball intervention.[17] It has been reported that peanut balls can reduce pain in some studies, but others have reported equivocal results regarding their impact on the method of delivery.

Systematic reviews and meta-analyses done have contributed to the comprehensive effects of peanut ball interventions.[3] Grenvik et al. (2019)[18] observed no statistically significant difference in duration of labor. However, a significant rise in vaginal delivery and decrease in cesarean delivery was reported. Conversely, a meta-analysis published in 2021 found peanut balls reduced labor duration significantly, but not delivery method or neonatal outcomes.[19]

A comprehensive assessment of the existing evidence indicates inconclusive results, primarily due to heterogeneity in study outcomes and limited sample sizes. In addition, global inequity in labor pain management, primarily across LMICs, affirms the need for affordable and evidence-based interventions. Therefore, RCTs with larger sample sizes and rigorous methodologies are required to the clarify peanut ball interventions’ effects on maternal and neonatal outcomes. This study seeks to explore the following questions based on the background.

Does peanut ball manipulation reduce the duration of labor and pain during labor?

Does peanut ball manipulation promote normal vaginal delivery and reduce maternal stress?

To answer the above questions, the following hypotheses were formulated:

H1: There will be a significant difference in the mean score of maternal outcomes between experimental and control arms.

H1.1a: There will be a significant difference in the mean duration scores of active first stages of labor.

H1.2b: There will be a significant difference in the mean duration scores of the second stage of labor

H2: There will be a significant difference in delivery between experimental and control arms.

H2.1a: There will be a significant difference in normal vaginal delivery between experimental and control arms.

H2.2b: There will be a significant difference in vacuum delivery between experimental and control arms.

H2.3c: There will be a significant difference in forceps delivery between experimental and control arms.

H2.4d: There will be a significant difference in cesarean deliveries between experimental and control arms.

H3: There will be a significant difference in the pain score between experimental and control arms.

H4: There will be a significant difference in the mean maternal cortisol levels between experimental and control arms.

Theoretical framework

The study was based on Wieden Bach’s theory of “the helping art of clinical nursing,” which highlights important nursing philosophy ideas, such as respecting each person’s autonomy, dignity, and individuality, honoring life as a precious gift, and respectfully acknowledging previous beliefs and choices.[20,21] The theory is described as realizing the demands and worries of patients, designing and achieving goals focused on improving patients’ capabilities and streamlining care activities to improve patients’ conditions.[20]

According to Wieden Bach’s “The Helping Art of Clinical Nursing’ theory, purposeful nursing actions are directed to a specific patient; thus, the helping art of nursing can be analyzed through the conceptual use of a peanut ball during labor. The intervention attempts to solve maternal problems by promoting optimal pelvic positioning, and aims at optimizing comfort, labor duration, and enabling vaginal delivery.

Throughout the intervention, emotional support is provided to manage stress and enhance the maternal experience during the birthing process. The intervention’s efficacy pertaining to peanut ball use was evaluated by the observation of controlled pain, pressure, and labor pain as well as longitudinal monitoring of its progress. The intervention was designed in the context of maternal preferences and delivery goals to ensure clinical relevance and acceptability. The process of application is depicted in Figure 1.

Figure 1.

A conceptual framework based on Wieden Bach’s theory of “The helping art of clinical nursing”

Materials and Methods

Study design and setting

The methodology of the current study was previously published in the study protocol.[22] This study used a single-blind randomized control trial. The study was conducted in a tertiary care teaching hospital in Udupi District, Karnataka State, India, for three years, from October 2019 to September 2022.

Study participants and sampling

The study population consisted of primigravid women classified as low risk, who were admitted to the labor ward for induction or delivery. The prior study served as a basis for study (Stjernholm et al., 2016),[23] which was used to calculate the required sample size, using the formula: [], “ n = sample size per group, =1.96 at α =0.05, Z_1-β =0.84 at 80% power, σ = standard deviation of the primary outcome variable stress level of the mother as measured by serum cortisol level = 2.58 µg/dl,[23] d = clinically significant difference = 0.55 µg/dl, where n = 346 in each group, accounting for a 10% dropout rate, increased to 384 in each group (768 in total), and the samples were randomly assigned to either the experimental or control groups. The process of randomization is depicted in Figure 2.

Figure 2.

CONSORT (2010) flow diagram showing the flow of participants through the trial.[22]

Inclusion criteria

The following criteria were included: primigravid women, who were deemed low risk, aged 20 to 40 years, had a gestational age of 37 to 41.6 weeks, carried a singleton fetus in cephalic presentation, planned for vaginal delivery, and agreed to utilize peanut ball during the first stage of labor”

Exclusion criteria

Women who were multigravida, had ‘multiple pregnancies, known fetal abnormalities, coexisting medical conditions like diabetes mellitus or pituitary disorder, were on steroid therapy, had a history of leg fracture, were contraindicated for vaginal delivery, or chose not to participate in the study were excluded.

Data collection tool and technique

To collect the data, researchers utilized the following tools.

The first tool was demographic and biological information form that contained variables like “years of marriage (in years),” “educational level, occupation,” and “family income per month (in INR).” Biological characteristics included “age (in years),” “gestation period (in weeks),” and “body mass index (BMI).” The second tool used was a structured observational tool titled “Record on the Outcome of Labor.” This tool captured data on “duration of the active first and second stages of labor,” “mode of delivery,” “need for pain medications,” “objective assessment of pain” during the active first stage of labor, and “serum cortisol levels.” Nine experts reviewed the content validity of the tools. The experts were in full agreement, and tools had a mean content validity index (CVI) score of one, which represents excellent content validity. Reliability of the tool was determined with the “inter-rater reliability method.” To determine the consistency, the tool was administered to 20 low-risk primigravid women by two observers, who were trained—a primary rater and a secondary rater—to reduce bias. The correlation coefficient (r = 1), revealed that there was a perfect agreement between the raters, establishing the excellent reproducibility and reliability of the tool.

Ethical consideration

Approval to conduct the research was obtained from the Medical Superintendent and Head of the Obstetrical and Gynecological Unit of the selected Tertiary Care Hospital. The study adhered to the ethical standards set forth in the Declaration of Helsinki and ICMR Ethical Guidelines. Prior to the initiation, ethical clearance was approved by Kasturba Hospital Manipal (IEC: 415/2019), an Institutional Ethics Committee. It was also registered with Clinical Trials Registry - India (CTRI/2019/08/020802). A preliminary assessment was carried out as per the inclusion and exclusion criteria for the low-risk primigravid mother arriving at the labor ward for delivery to determine eligibility before recruitment. The researcher then introduced herself and explained the participant information sheet, outlining the contact details, the study’s benefits, procedures, data confidentiality, voluntary participation, and their right to withdraw without any consequences, and confirmation that no potential risks were involved. Written informed consent was obtained from all participants before their enrollment. Additionally, all data were anonymized to ensure participant privacy.

Randomization and blinding

As recommended by Schultz and Grimes (2002), permuted block randomization with a fixed block size was employed to ensure balanced randomization. For the total sample size of 768, 64 blocks with a size of 12 were generated. To maintain the integrity of the randomization process, allocation concealment was implemented using “Sequentially Numbered Opaque and Sealed Envelopes” (SNOSEs) managed by external nursing staff. The participants, who received an envelope marked “1” were assigned to the experimental arm, whereas those with an envelope marked “2” were assigned to the standard care arm. While blinding the study assignment from participants was not feasible, the outcome assessor remained blinded during participant allocation, making this a single-blind study.

Intervention

Once eligible participants were assigned to blocks formed by the researcher, those in the experimental arm received peanut ball intervention upon reaching 3–4 cm cervical dilatation and being confined to bed, while the control arm received standard care. Demographic data were collected from all participants. Women in the experimental arm were then oriented to peanut ball use through an instructional video developed by the researcher, along with position chart sourced from Premier Birth Tools. Standard positioning techniques such as “side-lying,” “sitting,” “semi-sitting,” and the “tuck position” were applied during labor. The size of the peanut ball was selected based on the mother’s height: “40 cm for women 5’3” tall,” “50 cm for women 5’3” to 5’6” tall,” “60 cm for women 5’7” or taller or overweight,” and “70 cm for sitting or straddling.” These guidelines were followed as recommended by Premier Birth Tools. Trained research assistants supervised the positioning and provided support, adjusting every 20 to 40 min or as needed to maintain comfort. Participants were also monitored for any indications of fatigue/discomfort throughout the intervention. Blood samples for serum cortisol were collected at two stages: first at 3–4 cm of cervical dilation and again after full dilation. These samples were analyzed using standard biochemical methods.

Outcome measures

The study investigated the impact of peanut ball intervention on maternal outcomes via the “outcome of the labor assessment tool,” and the secondary outcomes included the perception of pain and maternal stress levels measured through the “visual analog scale for pain” and the “serum cortisol levels” at various stages of labor. Research assistants evaluated maternal outcomes at different stages and compared them between the experimental and control arms. At the time of discharge from the hospital, each participant was given a booklet on postnatal and newborn care as a complement.

Statistical analysis

The gathered data were examined via the “Statistical Package for Social Sciences (SPSS) version-16.” Depending on the normality of the data, two independent sample t-tests was conducted to assess the impact of peanut ball intervention on maternal labor outcomes. The relationships among the variables were analyzed through the chi-square test (for categorical variables) and one-way ANOVA (for continuous variables). The significance level was set at α =0.05, and the results were reported based on relative risk with a 95% confidence interval.

Results

The equality of variables between the experimental and control arms was evaluated at recruitment through the chi-square test for socio-demographic parameters and ANOVA for biological parameters. The results revealed that both statistical tests indicated P > 0.05, confirming that the experimental and control arms participants were similar at the point of recruitment [Table 1].

Table 1.

Descriptive statistics of socio-demographic and Biological characteristics of low-risk primigravid women (frequency and percentage) (n=768)

Characteristics		Experimental arm (n=384)				Control arm (n=384)				P
		f		%		f		%
Years of Marriage (in years)										0.059
Less than 1		132		34.4		98		25.5
1 to 3		224		58.3		243		63.3
4 to 7		24		6.2		37		9.6
8 to 10		03		0.8		05		1.3
More than 10		01		0.3		01		0.3
Educational status
Primary		06		1.6		10		2.6		0.285
High school		30		7.8		31		8.1
Higher secondary		85		22.1		103		26.8
Graduate and above		263		68.5		240		62.5
Occupation
Professional		96		25.0		100		26.0		0.855
Skilled worker		18		4.7		20		5.2
Un skilled worker		01		0.3		02		0.5
Self-employed		12		3.1		08		2.1
Home maker		257		66.9		254		66.1
Family income per month (in INR)
Less than 5000		50		13.0		46		12.0		0.887
5001–10000		18		4.7		17		4.4
10001–15,000		28		7.3		24		6.2
More than 15,001		288		75.0		297		77.3
Biological characteristics of low-risk primigravid women
		Mean SD				Mean SD				P
Mean Age (in years)		27.33±2.91				28.01±3.25				0.077
Period of gestation at enrollment (in weeks)		38.5±1.15				38.65±0.87				0.485
BMI		25.55±3.74				26.1014±4.0				0.594

The result also revealed that active phases of the first and second stages of labor were shorter in the experimental arm compared with the control arm. The mean difference was –105.934 min for the first stage, and –8.702 min for the second stage [Table 2]. Average durations between the two groups were compared using an independent t-test. There was a notable decrease in the duration of the active first stage of labor (t = –27.380, P = 0.001). It was also notable in the recording of the second stage of labor (t = –9.972, P = 0.01) for those in the experimental arm. [Table 2] These results validate research hypotheses H1.1a and H1.2b, indicating that the peanut ball intervention was effective in reducing labor duration among the participants involved in the study.

Table 2.

Duration of the active stage and second stage of labor N [E (343) + C (284)]=627

Duration (in minutes)		Arm		Mean		SD		Mean difference		‘t’		df		P
Active first stage of labor		Experimental		179.29		42.58		−105.934		−27.380		625		0.001*
		Control		283.23		54.27
Second stage of the labor		Experimental		39.68		9.64		−8.702		−9.972		625		0.001*
		Control		48.38		12.21

Key: Abbreviations: E- Experimental arm (used the peanut balls), C=Control arm (standard care),*Significant at P<0.05

The findings in Table 3 indicate that approximately 84.9% of the research participants in the experimental arm underwent normal vaginal delivery, whereas 68.8% of the research participants were in the control arm. The occurrence of assisted delivery and cesarean delivery was greater among the control arm. The chi-square test was used to assess the difference between the experimental and control arms that exhibited a P-value less than 0.05 (χ2 (3) =32.467, P = 0.001), indicating statistical significance. Consequently, the null hypotheses were rejected, and the research hypotheses (H2.1a, H2.2b, H2.3c, and H2.4d) were retained. This finding suggests that the peanut ball device is effective in inducing vaginal delivery.

Table 3.

Association between the nature of delivery and the use of peanut balls during labor (n=768)

Nature of delivery		Experimental arm (n=384) f (%)		Control arm (n=384) f (%)		χ2 test		df		P
Normal Vaginal Delivery (Spontaneous/Induced with episiotomy*)		326 (84.9)		264 (68.8)		32.467		3		0.001*
Vacuum delivery		8 (2.1)		8 (2.1)
Forceps delivery		9 (2.3)		12 (3.1)
Cesarean deliveries		41 (10.7)		100 (26.0)

Key:* indicates before starting an intervention

At the beginning of the study, 768 low-risk primigravid mothers were randomly allocated to the experimental (n = 384) and control (n = 384) arms. Among them, 41 mothers in the experimental arm and 100 mothers in the control arm underwent cesarean sections. As a result, the final analysis included 343 participants from the experimental arm and 284 participants from the control arm, yielding a total sample size of 627 [Table 3].

Results of the chi-square test revealed a substantial discrepancy in the reported pain levels between the experimental and control arms (χ2 df (1), (n = E (343) + C (284) =32.467, P = 0.012). This analysis was conducted after the implementation of the peanut ball intervention. However, the analysis revealed no statistically significant difference in the need for pain medication (P = 0.759) between the two arms [Table 4]. Consequently, the null hypothesis was rejected, and the research hypothesis (H3) was retained.

Table 4.

Association of level of pain among the experimental and control arms N=E (343) + C (284)]=627

Variables				Arm		f (%)		χ 2		df		P
Level of Pain		Moderate pain		Experimental		79 (23.1)		6.193		1		0.012
				Control		5 (1.8)
		Severe pain		Experimental		264 (79.8)
				Control		279 (98.2)
Need for pain medication		Yes		Experimental		67 (19.5)		0.697		1		0.759
				Control		52 (18.3)
		No		Experimental		276 (80.5)
				Control		232 (81.7)
Physician prescribed (pain medication) Control				Experimental		332 (96.8)		0.402		2		0.818
				273 (96.1)
The patient requested (pain medication) Control				Experimental		11 (3.2)
				11 (3.9)

Keywords: E=Experimental arm (the peanut ball), C=Control arm (standard care), df=degree of freedom, χ² test=chi square test*Significant at P<0.05

The repeated-measures ANOVA with Geisser correction indicated that the maternal serum cortisol level assessed at the second stage of active labor (10 cm cervical dilation) in the experimental arm (70.80 µg/dL) (F do (1,623) =975, P = 0.001)) was significantly lower than the mean cortisol level (72.08 µg/dL) in the control arm. Similarly, a significant interaction effect was observed between the experimental and control arms in the two-point analysis (F (1,623) =6134, P = 0.001). [Table 5] Hence, the null hypothesis was rejected, and the research hypothesis (H4) was retained. This can be interpreted as the peanut ball intervention lowered serum cortisol levels in the experimental arm during the active first stage of labor compared to the standard care received by the control arm.

Table 5.

The stress level of low-risk primigravid women who underwent normal vaginal delivery during the active first stage of labor N [E (343) + C (284)]=627

Serum Cortisol		Arm		n		Mean±SD		F		df		P
Before		Experimental		342		42.15±18.5		975		(1,623)		0.001*
		Control		283		44.38±22.6
After		Experimental		342		70.80±19.9
		Control		283		72.08±24.9

Keywords: E=Experimental arm (the peanut ball), C=Control arm (standard care), df=degree of freedom,*Significant at P<0.05

Discussion

The present study highlighted a notable reduction in the duration of labor, pain, and stress among low-risk primigravid women. The duration of the active first and second stage of labor was reported to be − 105.93 min and − 8.7 min shorter in the experimental arm as compared to the control arm. Similarly, when 23.1% of low-risk primigravid women in the experimental arm experienced moderate pain, 79.8% experienced moderate pain across the control arm.

The present study results are in line with those of Sena Fraga et al. (2024),[24] who observed a significant reduction in labor duration in women with peanut ball interventions. Likewise, systematic reviews by Suraci et al. (2020)[25] and Grenwick et al. (2023)[18] established reduced labor durations in pregnant women with birthing ball or mobility-based approaches The facilitation of fetal descent and cervical dilation resulting from peanut ball intervention could contribute to a shorter duration of labor as reported elsewhere (Emam and Al-Zahrani, 2018)[26]. Delgado et al. (2019)[3] carried out a systematic review comprising four randomized controlled trials with 818 participants, which also reported a significant reduction in the active phase of labor in women, who received peanut balls.[2,9,13,19]

There are a few studies that contradict our observation. For example, Mercier and Kwan (2018) reported that among nulliparous women, the implementation of peanut ball during labor failed in lowering the duration of the active stage of labor.[17] Likewise, a recent randomized controlled trial by Dikmen et al. (2024) reported the ineffectiveness of peanut balls in reducing labor duration.[17,24] The observed discrepancy could be attributed to either the smaller sample size or the influence of socio-cultural factors in the study.

Results of the present study also showed that participants in the control arm requested pain medication more frequently, which may indicate that the peanut ball intervention had a beneficial impact. This result is in line with that of Alan Dikmen et al. (2024),[27] who found that using peanut balls successfully decreased maternal fatigue and labor pain Additionally, the intervention increases maternal mobility during labor, promoting a sense of control and reducing the need for analgesia, according to Emam and Al-Zahrani (2018).[26]

These findings agree with Phalswal U et al. (2024),[28] who reported reduced pain in mothers, who took up birthing ball exercises, stressing the effectiveness of sitting in easing lower back pain during the exercise. Likewise, Hartati et al. (2024)[29] came up with a comparable finding focusing on the efficiency of combining yoga with the use of birthing balls or integrating a birthing ball with counter-pressure methods or free positioning in alleviating labor pain. The Peanut ball application has been proven to provide psychological as well as physical relief by encouraging the pelvic opening (Emam, and Al-Zahrani, 2018).[27] Therefore, the pain relief as reported by the participants could be due to the influence of the peanut ball intervention.

Similarly, Cavalcanti AC et al. 2019 reported similar findings following the use of warm showers, perineal exercises, and the application of a Swiss ball.[30] A meta-analysis by Navelia et al. (2023)[31] reported that pelvic rocking and birthing ball exercises are effective non-pharmacological interventions for reducing labor pain and improving labor outcomes, through rhythmic pelvic movements, promotes relaxation and facilitates fetal descent and lowered pain scores (mean difference: −1.19) and shortened the first stage of labor by approximately 1.13 hours, Hence, the shortened first and second stage of labor may be attributed to the peanut ball intervention.

The present research revealed increased normal vaginal deliveries (89.3%) and decreased cesaerean rates (10.7%) among the experimental group, Makvandi et al.,[32] and Emam and Al-Zahrani[26] also presented comparable results, associating peanut ball use with enhanced labor outcomes. This finding is also supported by Grenvik et al. (2023),[18] who reported that pelvic rocking and birthing ball exercises reduced labor pain by 20% at 4 cm and 8 cm cervical dilation, decreased the duration of the first stage by over 2 hours, and lowered cesarean section rates.

Our findings challenge previous conclusions presented by Mercier and Kwan (2018), who reported no significant difference in delivery outcomes between women receiving peanut ball intervention and those receiving standard care.[17] Although women in the experimental arm achieved full cervical dilation, the results were not statistically significant. Similar proportions of cesarean sections were indicated across both arms due to fetal status concerns and labor arrest. However, Hickey and Savage 2019 disputed Mercier and Kwan’s 2018 findings, advocating for the benefits of peanut ball intervention in increasing vaginal delivery rates. They reported a 61 percent vaginal delivery rate among pregnant women in the peanut ball arm compared with the percentage in the control arm,[17,33] which was supported by Grenvik et al.’s (2019)[34] similar outcomes. Discrepancies in Mercier and Kwan’s results could stem from smaller sample sizes.[17]

Findings of the present study showed significant difference in the stress level as measured by the maternal serum cortisol level measured at two time points, during the early stage of labor (at 3–4 cm of cervical dilation) shows that the control group mother serum cortisol levels were higher (44.2 µgm/dl ± 22.6) than the experimental group (42.2 µgm/dl ± 18.5) and later at 10 cm cervical dilatation maternal serum cortisol level in the experimental arm was lower (70.80 2 µgm/dl ± 19.9) than in control group (72.08 2 µgm/dl ± 24.9). The results of this study echoed findings seen in other non-pharmacological echo those of other non-pharmacological approaches to reducing stress. Owing to the scarcity of research on the effectiveness of birthing ball intervention in alleviating maternal, tress, we referenced findings from studies investigating various other nonpharmacological methods to corroborate our own observations. These include the impacts of music therapy,[35] cognitive behavioral therapy,[35] and distraction techniques.[1] Our findings align with those of Teckenburg-Jansson et al. (2019),[35] who noted a significant reduction in maternal stress following live music therapy. However, the author cautioned that such interventions might offer only partial or temporary relief, as participants could experience stress resurgence after a certain period of postintervention.[25] These results were previously discussed in Lin CJ et al.’s 2019[36] meta-analysis, though the authors noted weak methodological quality. Similar conclusions were also supported by studies examining the effects of cognitive behavioral therapy, distraction techniques, and yoga on reducing maternal stress and anxiety.[37,38]

Limitations

Despite the merits, the study had to face some limitations. Primarily, the COVID-19 pandemic, which occurred during the study period, might have triggered low-risk primigravid mothers’ anxiety about childbirth. The research team was aware that the experimental group was receiving the peanut ball intervention, which raised the possibility of ascertainment bias. Again, the nature of the intervention could not blind the participants or the researchers because of the nature of the intervention. Using SNOSEs, allocation concealment was used to reduce this prejudice with the assistance of outside nursing professionals. The participants’ adherence to the peanut ball intervention is another drawback. Constant positive guidance by the skilled nursing staff reduced this prejudice. Despite limitations the first RCT on peanut ball intervention carried out in India, it aimed to enhance delivery experiences and maternal satisfaction, and the findings provided insightful information for medical providers.

Recommendations

The present research is restricted to primigravid women with low-risk factors, there is a chance for researchers to explore how these interventions affect multigravida women and pregnant women facing complications. As the study was confined within a specialized teaching hospital, the replicability of the current findings can be extended to different research environments. There is a need to focus on cost‒benefit analyses of peanut ball intervention as compared with other nonpharmacological approaches, especially in resource-constrained lower‒middle-income countries like India. Moreover, more understanding of the knowledge, skills, and attitudes necessary for implementing the peanut ball intervention in an Indian setting should be taken up. Some studies have suggested that the benefits of combining birthing ball intervention with other methods, such as warm therapy, in wealthier countries should be explored thoroughly within Indian settings.

Conclusion

This randomized controlled trial demonstrates that using peanut ball exercise in obstetric care can effectively shorten the duration of labor, reduce pain, and decrease stress in low-risk primigravid mothers. These findings support the integration of this cost-effective, noninvasive intervention into standard maternity care protocols. Implementing such evidence-based practice enhances maternal health outcomes, optimizes resource utilization, and contributes to strengthening healthcare by promoting safe, efficient, and accessible childbirth intervention.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

This study is funded by the ICMR extramural agency (File No 5/7/58/MH/Adhoc/2019-0146/RBMCH).