Abstract
Background
Therapeutic play is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play with teddy bear on children's pain, anxiety, and mothers’ anxiety during peripheral intravenous catheterisation.
Methods
This prospective, randomised clinical trial consisted of children between the ages of 3–6 admitted to the pediatric service and their mothers (N = 120). The therapeutic play method with the teddy bear during peripheral intravenous catheterisation was applied in the Therapeutic play group (N = 60), and the standard procedure of the clinic was applied in the control group (N = 60). A questionnaire, the “FLACC” pain scale, the “CEMS” anxiety scale and “STAI-S” anxiety scale for parents were used to collect data.
Results
There was no significant difference in the pain and anxiety scores of the children before peripheral intravenous catheterisation between the groups (p > 0.05). During the peripheral intravenous catheterisation, pain and anxiety levels of children were lower in the Therapeutic play group (p < 0.001). There was no significant difference in the anxiety mean scores of the mothers between the groups before peripheral intravenous catheterisation (p > 0.05). During the peripheral intravenous catheterisation, anxiety levels of the mothers were lower in the Therapeutic play group (p < 0.001). A strong and positive correlation was found between the anxiety scores of mothers and pain and anxiety scores of children (p < 0.05).
Conclusion
Therapeutic play with teddy bear was effective in lowering pain and anxiety levels of children, and the anxiety levels of mothers during peripheral intravenous catheterisation.
Practical implications
Therapeutic play is an effective non-pharmacological intervention. Health care professionals have great responsibilities in using the structured therapeutic play method during painful procedures.
Trial Registration
NCT05823324, registered on 2023–04-09.
Keywords: Therapeutic play, Pain, Anxiety, Peripheral intravenous catheterisation
Highlights
Therapeutic play methods applied during painful procedures are effective in lowering the pain and anxiety levels of children.
When the pain and anxiety experienced by the children decreases, the anxiety of the parents decreases during the PIVC.
Health care professionals have great responsibilities in integrating the structured therapeutic play method into practice.
Introduction
Children in pediatric units often undergo a range of invasive procedures, including venipuncture, injections, and peripheral intravenous catheterization (PIVC) [1]. PIVC is one of the most frequently performed painful procedures in pediatric units [2]. In children, multiple attempts are often required for successful IV access, increasing pain and anxiety for the child and reducing parental satisfaction [3]. Managing procedural pain in pediatric patients is one of the most challenging issues in hospital care [4]. This experience impairs effective communication between children and healthcare professionals and causes problems in adapting to care and treatment in the hospital setting [5]. Pain-related stress not only affects physical, social, and cognitive functioning but also impairs the emotional and mental health of children [6].
As one of the non-pharmacological pain relief methods, therapeutic play (TP). is a distraction that is defined as “the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose” [7, 8]. In order to call play with a child who is hospitalized as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalization, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits [9–11]. Children could be told facts such as the hospitalization, the procedures to be followed and the time when this procedure would end through TP [12–14]. Drama therapy is a type of TP, which is a creativity-based approach that helps the individual to gain an insight into his or her inner self. Other forms of TP include educational games, which teach children about their medical conditions and procedures; cathartic games, which allow children to express and release pent-up emotions; and creative play, which uses art, music, or imaginative activities to foster emotional expression and exploration [15].
Upon a literature review, it is seen that TP methods applied during acute painful procedures such as venipuncture, blood sampling, and PIVC are effective in lowering the pain and anxiety levels of children [10, 16–20]. The study by Lemos et al. [21] with preschool and school-age children who were hospitalised reported that TP used during vascular access can be used as an effective treatment method to alleviate the pain of children. In their study, Crevatin et al. [19] found that TP methods applied for children between the ages of 4–13 during invasive procedures lowered their pain levels. Derleyen [13] used the therapeutic play method in children aged 7–12 years during PIVC and concluded that the anxiety and fear levels of children dropped. Demirel and Topan [7] applied the TP method during the medical procedure for hospitalised children aged 7–14 years and found that this method alleviated anxiety and fear. In the literature, there are studies using different TP methods to reduce pain and anxiety during PIVC in children [7, 21–24]. However, most of these studies have been conducted in older age groups and very few studies have been conducted in the 3–6 years age group. Therefore, it is important to further investigate the effects of therapeutic play in this age group.
It is considered that the hospital setting would no longer be a stressful, frightening, suffering and painful place for children and their parents if paediatric health care professional use play as a communication tool during care and treatment practices [20, 24]. In this study, the use of dramatic TP. It included a demonstration of the PIVC procedure on a teddy bear and a structured conversation about the child's emotions. This study aimed to investigate the impact of dramatic therapeutic play using a teddy bear on pain and anxiety in children aged 3–6 years, as well as on their mothers'anxiety, during PIVC. This is an area that has not been extensively investigated in the literature. In addition, there is no study in the literature showing the relationship between mothers’ anxiety and child pain and anxiety.
Hypotheses of the study;
H1: TP using drama technique is effective in reducing pain in children during PIVC.
H2: TP using drama technique is effective in reducing anxiety in children during PIVC.
H3: TP using drama technique is effective in reducing anxiety in mothers during PIVC.
H4: There is a relationship between mothers'anxiety and children's pain and anxiety during PIVC.
Methods
Study design
This study was conducted in a prospective randomized clinical trial.
Participants
The population of the study consisted of children hospitalized in the general pediatric unit of a training and research hospital between February 2020 and June 2020 and their mothers. There are a total of 12 rooms and 24 beds in the pediatric unit. The routine PIVC procedure is performed by two nurses when the patient is admitted to the unit, after the anamnesis is taken in the treatment room, the parent is also taken to the procedure room. Since one of the general rules of the unit is that only the mother can stay with the children as a parent, only the mother of the child is present as a parent during the PIVC procedure. No non-pharmacological method is applied to reduce pain and anxiety during the PIVC procedure in the unit.
The inclusion criteria were determined as follows: (1). age 3 to 6 years, (2). inpatient treatment in the pediatric service with upper respiratory tract infection, (3). no mental disability or chronic disease, (4). able to speak and understand Turkish for children and their mothers, and (5). voluntary to participation in the study mothers. We focused on children with respiratory tract infections because it is estimated in the literature that pain associated with such conditions is generally less compared to other conditions such as surgical and orthopedic pain [24]. Children who used other non-pharmacological techniques, used local anesthetic cream, more than two unsuccessful PIVC attempts, and who were given pain medication in the hours before the procedure were not included in the study.
The sample size of the study was calculated using a power analysis for an independent t test. Based on the study by He et al. (2015), therapeutic play was assumed to have a medium effect size on children’s anxiety. To achieve the expected medium effect size of 0.69 [Cohen’s d = 0.69]. and 95% power, with a statistically significant level at 0.05 (α = 0.05) (two-tailed) for the difference in children’s anxiety between the TP and control groups, the calculated required sample size was 112, with 56 participants in each group. Considering potential attrition in the study, the sample size was increased by approximately 10% to reach 60 children in each group. This helped increase the statistical power of our study and made our results more reliable. The G-Power (Ver. 3.1.9.4). software was used for the power analysis calculations.
The block randomization method was selected as the preferred approach to the maintenance of balance in the number of children in each group, for which 20 different combinations were created using a block size of six, represented by the letters A, B [AAABBB[1]., AABBBA[2]., ABBBAA[3].…].. The combinations were assigned numbers [1–19]., and a random sequence was generated on https://www.randomizer.org/ using these numbers. The allocation of each child to any of the groups was determined by the sequence of the PIVC (1–120) by the same researcher. This researcher was independent of the nurse who implemented the intervention.
Blinding
Parents and children were not given information about the other group in the study (TP and control). As the intervention was performed by the researcher, blinding could not be performed. To prevent bias during data analysis, the study groups were coded as A and B in the database and analysis of data was performed by a statistical expert independent of the research.
Interventions
Before the data collection process, the researcher attended a Therapeutic Play Certificate Program and received a certificate. The program lasted for 100 h. Seventy hours of the program was held online and 30 h was held face-to-face.
TP Group
Children in the TP group received five minutes of dramatic TP through structured conversation about their feelings and demonstration of the PIVC procedure on a teddy bear by the same researcher. The questionnaire was completed with the child and his/her mother approximately ten minutes before the procedure. Face, Legs, Activity, Cry, Consolability (FLACC) pain scale and Children’s Emotional Manifestation Scale (CEMS) were completed for the child, the State-Trait Anxiety Inventory-S (STAI-S) was administered to the mother five minutes before the TP. The PIVC materials and a teddy bear were then taken to the examination room. The PIVC procedure was demonstrated to the children and their mothers using the teddy bear for about five minutes just before PIVC. The PIVC was then performed. During PIVC, the other nurse continued to distract the child's attention with the teddy bear. During the intervention, when a tourniquet is applied to the child's arm, the FLACC and CEMS were repeated for the child and the STAI-S was repeated for the mother.
Teddy bears were a plush toy suitable for children between the ages of 3 and 6 and were washed and cleaned after each procedure. A total of six teddy bears were purchased by the researchers for the study (Fig. 1).
Fig. 1.
Teddy Bear in TP Group
Control Group
Children in the control group underwent the routine procedure of the clinic. Within the scope of the routine invasive procedure of the clinic, the mothers accompany their children and are involved in the procedure. Before the procedure, the child and the mother were taken to the examination room and the questionnaire was filled out. FLACC and CEMS were completed for the child just before the PIVC procedure. The STAI-S was applied to the mother. During the intervention, FLACC and CEMS were also applied for the child and the STAI-S was applied for the mother.
During the PIVC procedure, the mothers of the children in both groups accompanied their children and were involved in the procedure. All the assessments of FLACC and CEMS were performed by the same two nurse observers, who were previously informed about the purpose of the study and the use of the scales, and had similar clinical experience. The same nurse performed all PIVC procedures.
In both groups, mothers were present with their children, and holding their hands during the procedure.
Data collection tools
The data collection tools were a Descriptive Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) pain scale, Children’s Emotional Manifestation Scale (CEMS) to determine the anxiety of the children and State-Trait Anxiety Inventory-S (STAI-S) to determine anxiety of mothers.
Descriptive Information Form: The form, prepared by the researchers, consists of two sections and a total of 29 items, concerning the demographic characteristics of the children and their mothers and about the PIVC prosedure (previous experience, number and duration of PIVC).
Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC)
The FLACC was used to assess the children’s pain scores [25]. It was developed by Merkel et al. in 1997 [24]. The validity and reliability study of the scale was conducted by Sezer et al., (2021) [26]. The FLACC used for children aged 2 to 7 years consists of five categories: Face, Legs, Activity, Cry, and Consolability. Each category has three items rated between 0 and 2 points. The scale is scored between 0 and 10 points indicating “0”: the child is relaxed and calm, “1–3”: the child is mildly uncomfortable, “4–6”: the child has moderate pain and “7–10”: the child has severe pain. The Cronbach’s alpha coefficient of the scale was 0.88. In the present study, Cronbach’s alpha value was 0.966 before PIVC and 0.813 during PIVC. Two independent nurses assessed the pain. These nurses had training in scale assessment. In the inter-observer fit analysis of the pain scale, the correlation coefficient was 0.956 before the intervention and 0.944 during the intervention.
Children’s Emotional Manifestation Scale (CEMS)
The CEMS was used to assess the children’s anxiety level [27]. It was developed by Li and Lopez (2005) with the aim of measuring children's emotional reactions during painful and stressful medical procedures observed by a parent or researcher [28]. The validity and reliability study of the scale was conducted by Yanık et al., (2019). The CEMS scale was originally developed for children aged 7–12 years. The Turkish validity and reliability study reported that the anxiety experienced by children aged 3–6 years during hospitalisation and medical procedures can be easily assessed by parents or health professionals through observation using the CEMS [28]. The CEMS comprises 5 sections [facial expressions, noises made, activity, interaction, and cooperation]. to assess observation based emotional behavior. For each section, the child's behavior is rated from 1 to 5. Total points that can be obtained range from 5 to 25. As the scores obtained from the scale increase, negative emotional manifestations increase in direct proportion. The Cronbach’s alpha value of the scale is 0.92. In the present study, its Cronbach’s alpha value was 0.835 before PIVC and 0.906 during PIVC. Two independent nurses assessed the scale. These nurses had training in scale assessment. In the inter-observer fit analysis of CEMS, the correlation coefficient was 0.894 before PIVC and 0.904 during PIVC.
To determine inter observers’ agreement, these two nurses’ intraclass correlation coefficients (ICC) were calculated. ICC ranged from 0.89 to 0.95 before and during the PIVC for the scales of FLACC and CEMS.
State-Trait Anxiety Inventory (STAI-S)
The STAI-S was used to assess the anxiety mean scores of the mothers [23]. It was developed by Spielberger (1973) [29]. The validity and reliability study of the scale was conducted by Öner and Le Compte (1983) [30]. This self-assessment scale with brief statements comprises a total of 40 items, including 20 items in each of two sections, the “state anxiety inventory” and the “trait anxiety inventory”. The ‘State Anxiety Inventory’ was designed to determine what was felt at that moment and the ‘Trait Anxiety Scale’ was designed to determine what was felt in the last week. The “State Anxiety Inventory” was used in this study. Total score ranges between 40 and 160 points. The Cronbach’s alpha coefficient of the scale was 0.86. In the present study, Cronbach’s alpha value was 0.868 before PIVC and 0.924 during PIVC.
Ethical considerations
Ethics Committee approval (31/01/2020; Decision No: 22) and institutional permission [22/10/2020; Number: 45793301–604.01.01] were obtained before beginning the study. All methods were carried out in accordance with the Declaration of Helsinki. This study was retrospectively registered at ClinicalTrials.gov (NCT05823324). The study conformed to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The parents of children who met the inclusion criteria were informed about the purpose, content, and method of the study and how the collected information would be used through the ‘Informed Consent Form’ before the application, and the mothers, of whom verbal and written consents were obtained, and their children were included in the study.
Data analysis
The data were analysed using licensed Statistical Package for Social Sciences 22 (IBM SPSS Turkey) software. Descriptive statistics included mean, standard deviation, frequency, minimum, maximum, and percentage values. The distribution of the variables was assessed using Kolmogorov–Smirnov and Shapiro–Wilk tests, confirming that the data did not follow a normal distribution (e.g., Shapiro–Wilk, p < 0.05). Consequently, median values and interquartile ranges were used as measures of central tendency to better represent the data. The analyses revealed right-skewed distributions where extreme high values increased the mean compared to the median. Non-parametric tests were performed: Mann–Whitney U test was used for quantitative independent data to compare distributions between groups, Chi-Square test for qualitative independent data, and Spearman’s correlation test for monotonic relationships between variables. Results were assessed at a significance level of p < 0.05 within a 95% confidence interval.
Results
One hundred and twenty children took part in the study. Each group was allocated 60 (Fig. 2). There was no significant difference in terms of gender, mean age, hospital experience, previous invasive procedure experience (PIVC, blood sampling), and number and duration of PIVC procedures between the children in the study groups (p > 0.05) (Table 1). There was no significant difference in terms of age, educational background, employment, family type and the number of children between the mothers in the study groups (p > 0.05) (Table 2).
Fig. 2.
CONSORT flow diagram
Table 1.
Descriptive and Clinical Characteristics of the Children (N = 120)
| Characteristics |
TP Group (N = 60) |
Control Group (N = 60) | Total | Test; p | |
|---|---|---|---|---|---|
| Gender (n/%) | Female | 26 (43.3%) | 18 (30%) | 44 (36.7%) | X2 = 2.297; p = 0.092 |
| Male | 34 (56.7%) | 42 (70%) | 76 (63.3%) | ||
| Age (years) | X ± SD; | 4.45 ± 1.08 | 4.77 ± 1.1 | 4.61 ± 1.09 | U = 1.410; p = 0.114 |
| Previous hospitalization (n/%) | Yes | 24 (40%) | 25 (41.7%) | 49 (40.8%) | X2 = 0.034; p = 0.853 |
| No | 36 (60%) | 35 (58.3%) | 71 (59.2%) | ||
| PIVC experience (n/%) | Yes | 45 (75%) | 45 (75%) | 90 (75%) | No significant difference* |
| No | 15 (25%) | 15 (25%) | 30 (25%) | ||
|
Number of PIVC attemps (current) (n/%) |
1 | 32 (53.3%) | 31 (51.7%) | 63 (52.5%) | X2 = 0.052; p = 0.85 |
| 2 | 28 (46.7%) | 30 (48.3%) | 58 (47.5%) | ||
| Time to succesful of PIVC (second) (current) | (X ± SD) | 84.67 ± 55.65 | 85.58 ± 61.88 | 85.12 ± 58.76 | U = 1738.5; p = 0.744 |
X2 chi-square test, U Mann–Whitney U test, X ± SD Mean ± standard deviation, P level of significance, PIVC Peripheral Intravenous Catheterization, TP Therapeutic play
*No statistical analysis was performed for PIVC experience due to the lack of difference between the groups
Table 2.
Descriptive Characteristics of the Mothers (N = 120)
| Characteristics | TP Group (N = 60) |
Control Group (N = 60) |
Total | Test; p | ||
|---|---|---|---|---|---|---|
| Age | (X ± SD) | 31.38 ± 5.79 | 31.5 ± 5.73 | 120 (100%) | U = 1765.5; p = 0.856 | |
| Education level (n/%) | Uneducated | 18 (30%) | 7 (11.7%) | 25 (20.8%) | X2 = 0.074; p = 0.079 | |
| Primary School | 10 (16.7%) | 19 (31.7%) | 29 (24.2%) | |||
| High School | 24 (40%) | 27 (45%) | 51 (42.5%) | |||
| University | 8 (13.3%) | 7 (11.7%) | 15 (12.5%) | |||
| Employment status (n/%) | Employed | 20 (33.3%) | 12 (20%) | 32 (26.7%) | X2 = 0.062; p = 0.074 | |
| Unemployed | 40 (66.7%) | 48 (80%) | 88 (73.3%) | |||
| Type of Family (n/%) | Nuclear | 39 (65%) | 45 (75%) | 84 (70%) | X2 = 2.727; p = 0.103 | |
| Extended | 17 (28.3%) | 15 (25%) | 32 (26.7%) | |||
| Broken | - | 4 (6.7%) | 4 (3.3%) | |||
| Number of Children (n/%) | 1–2 | 24 (40%) | 28 (46.7%) | 52 (43.3%) | X2 = 0.543; p = 0.29 | |
| 3 and more | 36 (60%) | 32 (53.3%) | 68 (56.7%) | |||
X2 chi-square test, U Mann–Whitney U test, X ± SD Mean ± standard deviation, P level of significance, PIVC Peripheral Intravenous Catheterization, TP Therapeutic play
The FLACC mean scores of the children in the therapeutic play group were 2.8 ± 2.08 before PIVC and 4.45 ± 3.18 during PIVC, indicating an increase of 1.65 (p < 0.001). The scores of those in the control group were 3.68 ± 2.97 before PIVC, and 7.25 ± 2.81 during PIVC, indicating an increase of 3.57 (p < 0.001). There was no significant difference in terms of the pain mean scores between the children in the study groups before PIVC (p > 0.05), but the pain mean scores of the children in the TP group were lower during PIVC (p < 0.001) (Table 3).
Table 3.
Pain and Anxiety Scores of the Children (N = 120)
| Pain and Anxiety Scores |
TP Group (N = 60) |
Control Group (N = 60) |
Test; p | |
|---|---|---|---|---|
| FLACC Scores | ||||
| Before PIVC | Min–Max, X ± SD (M) | 0–10; 2.80 ± 2.08 (2.5) | 0–10; 3.68 ± 2.97 (3) | U = 1636; p = 0.618 |
| During PIVC | Min–Max, X ± SD (M) | 0–9; 4.45 ± 3.18 (4) | 0–9; 7.25 ± 2.81 (7) | U = 1234; p = 0.000 |
| Test; p | Z = -6.486; **p = 0.001 | Z = -6.986; **p = 0.000 | ||
| CEMS Scores | ||||
| Before PIVC | Min–Max, X ± SD (M) | 5–22; 18.88 ± 4.86 (17) | 8–25; 19.6 ± 5.2 (18) | U = 1710.5; p = 0.416 |
| During PIVC | Min–Max, X ± SD (M) | 5–25; 6.08 ± 5.91 (5) | 6–25;18.8 ± 6.34 (16) | U = 540;p = 0.000 |
| Test; p | Z = -6.946; p = 0.000 | Z = -2.434; p = 0.684 | ||
U Mann–Whitney U test, Z Wilcoxon signed-rank test, X ± SD Mean ± standard deviation, M Median, P level of significance, PIVC Peripheral Intravenous Catheterization, TP Therapeutic Play, FLACC Face, Legs, Activity, Cry, Consolability, CEMS Children’s Emotional Manifestation Scale
The CEMS mean scores of the children in the TP group were 18.88±4.86 before PIVC and 6.08±5.91 during PIVC (p<0.001), whereas they were 19.6±5.2 before PIVC and 18.8±6.34 during PIVC in the control group (p> 0.05). There was no significant difference in terms of the anxiety mean scores between the children in the study groups before PIVC (p> 0.05), but the anxiety mean scores of the children in the TP group were lower during PIVC (p<0.001) (Table 3).
The STAI-S mean scores of the mothers in the therapeutic play group were 54.73 ± 10.2 before PIVC and 38.06 ± 18.9 during PIVC (p < 0.05), whereas those of the mothers in the control group were 52.8 ± 9.81 before PIVC and 64.68 ± 18.56 during PIVC (p < 0.05). There was no significant difference in the anxiety mean scores between the mothers in the study groups before PIVC (p > 0.05), but the anxiety mean scores of the mothers in the TP group were lower during PIVC (p < 0.001) (Table 4).
Table 4.
Anxiety Scores of the Mothers (N = 120)
| STAI-S Scores |
TP Group (N = 60) |
Control Group (N = 60) |
Test; p | |
|---|---|---|---|---|
| Before PIVC | Min–Max, X ± SD (M) | 29–75; 54.73 ± 10.2 (51) | 32–70; 52.8 ± 9.81 (49) | U = 1810.5; p = 0.812 |
| During PIVC | Min–Max, X ± SD (M) | 21–78; 38.06 ± 18.9 (32) | 21–80; 64.68 ± 18.56 (56) | U = 530; p = 0.000 |
| Test; p | Z = −5.462; p = 0.021 | Z = −4.848; p = 0.034 |
U Mann–Whitney U test, Z Wilcoxon signed-rank test, X ± SD Mean ± standard deviation, M Median, P level of significance, PIVC Peripheral Intravenous Catheterization, TP Therapeutic play, STAI-S State-Trait Anxiety Inventory-S
It was found that there was a positive statistically significant correlation between the anxiety mean scores of the mothers and the pain and anxiety mean scores of the children within and between groups, before and during PIVC (p < 0.001) (Table 5).
Table 5.
Correlation between the Mothers'Anxiety Levels and the Children's Pain and Anxiety Levels (N = 120)
|
Children (X ± SD) |
Mother (X ± SD) |
Children Pain-Anxiety and Mother Anxiety (r; p) |
||||
|---|---|---|---|---|---|---|
|
TP Group (N = 60) |
Before PIVC | Pain | 2.80 ± 2.08 | 0.484; < 0.001 | 0.446; < 0.001 | |
| Anxiety | 18.88 ± 4.86 | 54.73 ± 10.2 | 0. 432; < 0.001 | |||
| During PIVC | Pain | 4.45 ± 3.18 | 0.695; < 0.001 | 0.655; < 0.001 | ||
| Anxiety | 6.08 ± 5.91 | 38.06 ± 18.9 | 0.607; < 0.001 | |||
| Control Group (N = 60) | Before PIVC | Pain | 3.68 ± 2.97 | 0.774; < 0.001 | 0.260; < 0.001 | |
| Anxiety | 19.6 ± 5.2 | 52.8 ± 9.81 | 0.305; < 0.001 | |||
| During PIVC | Pain | 7.25 ± 2.81 | 0.816; < 0.001 | 0.546; < 0.001 | ||
| Anxiety | 18.8 ± 6.34 | 64.68 ± 18.56 0.726; < 0.001 | ||||
Spearman test; P level of significance, PIVC Peripheral Intravenous Catheterization, TP Therapeutic play
Discussion
Invasive procedures like venipuncture, blood sampling, injections, and peripheral intravenous catheterization can be distressing for children, leading to anxiety and pain [31]. The pain, anxiety, and fear experienced during these procedures can, in some cases, result in children developing a long-term fear of hospitalization [1]. Therefore, it is crucial that health care professionals use evidence-based, effective, non-pharmacological methods when providing health care to children.
Distraction techniques such as listening to music, watching cartoons, playing video games, and inflating balloons are used to divert a patient's attention away from a stressful situation [32]. This trial was conducted to determine the effects of dramatic TP with teddy bear on pain and anxiety levels of children aged 3–6 years and their mothers’ anxiety undergoing PIVC.
When the literature was reviewed, gender, age, previous hospital experiences, and number of PIVC attempts of children were reported to affect pain and anxiety during invasive procedures [8, 33, 34]. In this study, there was no statistical difference between the descriptive characteristics of the children and their mothers between the groups (p > 0.05). Our analysis did not reveal a statistically significant relationship between these demographic factors and children's pain and anxiety scores. Specifically, as shown in Table 1, the groups were similar with respect to gender, age, previous hospitalization, and number of PIVC attempts. This lack of association may be due to the relative homogeneity of our sample regarding these factors. Additionally, the standardized nature of the PIVC procedure may have minimized the influence of individual patient characteristics on pain and anxiety outcomes.
In this study, TP with teddy bear was shown to effectively reduce pain experience and anxiety during PIVC in children. The study by Lemos et al. [21] with preschool and school-age children who were hospitalised reported that TP used during vascular access can be used as an effective treatment method to alleviate the pain of children. In their study, Crevatin et al. [19] found that TP methods applied for children between the ages of 4–13 during invasive procedures lowered their pain levels. The study by Aslan and Erci [35] found that playing with toys made of medical materials was effective in relieving pain in children during IV treatment. Derleyen [13] used the TP method in children aged 7–12 years during PIVC and concluded that the anxiety and fear levels of children dropped. The study by Koç and Alemdar [36] observed that the use of musical xylophone toy during peripheral venous access procedures in children was effective in reducing anxiety scores by children. The study by Uslu [37] found that 6–10-year-old children who played with a toy before the PIVC procedure had reduced levels of pain, fear and anxiety. The study by Tuncay and Sarman [1] the ventriloquist intervention was shown to effectively reduce fear, pain and anxiety during invasive procedures.
According to our results, children who played with a teddy bear during the PIVC procedure displayed fewer negative emotional signs. It is thought that this result will reduce the fear of long- term hospitalisation in children. Also, it is recommended that the efficacy of using the teddy bear be assessed in different age groups, with different painful procedures, using different pain scales and larger sample sizes.
Also, there are some reasons for parents to suffer from anxiety, such as the change in routines during the hospitalisation process, the thought that they would not be able to relieve their children’s pain, anxiety and fears during this process, and the presence of other children who stay at home and whom they have to take care of [38, 39]. Therefore, it is known that parents are unable to sufficiently support their children due to the concerns and anxieties they experience during their children’s illness and hospitalisation processes. Parental support during painful invasive procedures on their children and their involvement in therapeutic methods to comfort their children may contribute to parents to have more self-confidence and decreased anxiety levels [13, 39, 40].
In this study, TP with teddy bear was shown to effectively reduce mothers’ anxiety during PIVC. It was also observed that there was a relationship between the mothers'anxiety scores and their children's pain and anxiety scores, and as the mothers'anxiety scores decreased, so did the children's pain and anxiety scores. A study by Gündüz et al. [41] reported that when parents talked with their children about the procedures to be performed in the hospital before the procedure and made them psychologically ready, this greatly alleviated their fear and anxiety associated with invasive procedures. Parental role-playing of what may happen in the hospital environment by pretending to be a doctor with the child can also alleviate the stress and fear in the child [42]. In their study, Li et al. [43] concluded that therapeutic play applied for children who would undergo outpatient surgery with the involvement of their parents alleviated concern and anxiety in children and their parents. It appears that involving parents during painful procedures helps reduce the pain, anxiety levels of both parents and their children. In addition to the primary findings, it is noteworthy that the mean pre-procedure anxiety scores of mothers in the therapeutic play [TP]. group were higher, although not statistically significant. This observation may be attributed to several factors. Firstly, mothers in the TP group might have received more detailed information about the procedure beforehand, which could have heightened their awareness and concern. This increased awareness could potentially lead to higher anxiety levels as mothers might have been more informed about the potential risks or complications associated with the procedure. Secondly, the emotional investment of mothers in the TP group could also play a role, as they might have been more engaged with their children's emotional state and thus experienced increased anxiety themselves. However, the lack of statistical significance suggests that this difference may not be clinically meaningful, and further research is needed to fully understand the dynamics at play.
In this way, our study is important in terms of showing that the use of a teddy bear as a therapeutic play during PIVC procedures reduced the pain, anxiety levels and emotional symptoms of children and their parents.
Strenghts and limitations
One of the main strengths of our study is that it is among the limited number of studies examining the use of dramatic TP in children aged 3–6 years during PIVC. The scarcity of studies evaluating the effectiveness of this method in this age group makes our research a significant contribution to the field. Additionally, our study is one of the pioneering studies showing the relationship between mothers'anxiety and children's pain and anxiety. Revealing this relationship provides an important step for understanding the role of parents in the development of children's pain management strategies. Finally, the fact that our study is a randomized controlled trial (RCT) increases the reliability and internal validity of our results.
There are several limitations to this study. The first limitation is that the data collection period coincided with the COVID-19 pandemic period and the research nurses had to work in the COVID-19 wards from time to time. Secondly, the study was originally planned to be conducted with mothers and fathers, but as only mothers were present at the clinic during this period, fathers could not be included in the study. Thirdly, mothers'trait anxiety levels were not taken into account when sampling in this study. Fourthly, the study measures the effect of TP on children's adaptation to the PIVC process and on reducing anxiety. However, the follow-up time may be too short to assess the long-term effect. Fifthly, the researchers had no prior relationship with the child, which may have led to the child remaining silent during the procedure. Sixth, the study may have had limitations in controlling for external factors. For example, other factors in the child's treatment process (supportive treatments, family support, hospital environment, etc.) may influence the child's adaptation in ways other than TP. Seventh, in the study the nurse made a maximum of two attempts at PIVC. The second attempt may have influenced pain and anxiety levels. However, the groups were similar in terms of the number of PIVC attempts. Eighth, we did not perform a formal intention-to-treat (ITT) analysis; however, we assert that this did not significantly impact our findings, as the dropout rate was low and balanced across groups, and the primary outcome measures were objective and not susceptible to bias due to participant adherence. Finally, the study was conducted in a single hospital, so the socioeconomic status and physical environment of the patients may differ from the general population. This may limit the generalisability of the results and studies with a larger social sample may be needed.
Implications for practice
A holistic approach and care are required for children to positively experience the hospitalisation process. Health care professionals working in the field of pediatrics have great responsibilities in integrating the structured TP method into practice. Health care professionals should not distance themselves from the child during the procedures they perform, and should communicate with expressions similar to those used by the child by adapting to his/her imaginary world through different play methods. TP is an effective non-pharmacological intervention. We also think that the TP method provides effective communication and mutual trust between the health care professionals, children, and their parents, and positively affects the hospitalization process.
Conclusions
This randomized controlled trial demonstrated that TP significantly reduced pain and anxiety in children aged 3–6 years undergoing peripheral PIVC. Furthermore, a notable decrease in anxiety levels was observed in mothers. As the mothers'anxiety decreased, so did the pain and anxiety experienced by their children.These findings support the idea that TP methods can be an effective tool in improving children's hospital experiences and reducing parental stress. In conclusion, it is recommended that TP methods be structured in accordance with the age and cognitive level of children and be frequently used during painful procedures. Further randomized controlled trials in this area will contribute to a better understanding of the effectiveness and clinical applications of TP.
Acknowledgements
We would like to thank to the healthcare professionals working in the clinic and to the patients and mothers who agreed to participate in the study.
Authors’ contributions
S.Ç. and S.A. conceptualized and designed the study; S.Ç. administrated the project and data collection; S.A. coordinated and supervised data collection; S.A. performed data analysis; S.A. drafted the initial manuscript; and S.Ç. critically reviewed and revised the manuscript. All the authors read and approved the final version of the manuscript.
Funding
The authors have no funding to disclose.
Data availability
Data is provided within the manuscript or supplementary information files.
Declarations
Ethics approval and consent to participate
Haliç University Ethics Committee approved the study [31/01/2020; Decision No: 22]. and institutional permission from the hospital [22/10/2020; Number: 45793301–604.01.01]. were obtained before beginning the study. All methods were carried out in accordance with the Declaration of Helsinki. This study was retrospectively registered at ClinicalTrials.gov [NCT05823324].. The parents of children who met the inclusion criteria were informed about the purpose, content, and method of the study and how the collected information would be used through the ‘Informed Consent Form’ before the application, and the mothers, of whom verbal and written consents were obtained, and their children were included in the study. All methods were carried out in accordance with the Declaration of Helsinki.
Consent for publication
Not Applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Data Availability Statement
Data is provided within the manuscript or supplementary information files.