Effect of using a birth ball on birth satisfaction and pain in pregnant women during labor: a randomized controlled trial

doi:10.21203/rs.3.rs-4837446/v1

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Research Article

Effect of using a birth ball on birth satisfaction and pain in pregnant women during labor: a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-4837446/v1

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Purpose

This study was applied to evaluate the effect of birth ball use on birth satisfaction and pain levels of pregnant women during labor.

Methods

The type of study is randomized controlled. The data of the study were collected in the delivery room of a state hospital in blinded between March 2020 and December 2021. The sample of the study consisted of 57 pregnant women for the intervention group and 54 pregnant women for the control group. During labor, intervention group was seated on the birth ball in an upright position; control group was laid on the bed in semi fawler or lateral positions. In the study, Descriptive Information Form, Birth Process Follow-up Form, Visual Analog Scale and Birth Satisfaction Scale-Revised were used as data collection tools.

Results

It was determined that the pain scores of the pregnant women in the intervention group were lower during the first and second follow-up than the control group. The duration of the active phase of labor in the intervention group was shorter than in the control group, and a statistically significant difference was found between them. It was found that the Birth Satisfaction Scale-Revised total score, the sub-dimensions of quality of care, women’s attributes and stress experienced during labor of the pregnant women in the intervention group were higher than the control group.

Conclusion

According to the results of the study, the use of a birth ball during the active phase of labor reduces the pain level during labor and increases the level of birth satisfaction of pregnant women.

Birth ball

birth satisfaction

pain

midwife

Birth is the most important experience in a women's life. Birth satisfaction represents a complex and multidimensional construct that can be influenced by a number of situational, cognitive and emotional factors [1, 2]. The four most important factors determining mothers' birth satisfaction levels are their personal expectations, the support they receive during birth, the quality of the caregiver-patient relationship (e.g., respect, communication, continuity of care), and participation in the decision-making process [3]. Birth satisfaction may be influenced by variables such as the use of induction during labor, the use of medical interventions and midwife-led births [4, 5]. High quality and personalised maternity care during childbirth is a factor associated with very positive birth satisfaction [3, 5]. Women's level of satisfaction with labor can affect both mother and baby [6]. A negative birth experience can lead to decreased maternal infant attachment and desire to breastfeed, increased sexual dysfunction, post-traumatic stress disorder, and depression [6, 7].

Also, the main purpose of intrapartum care is the management of labor pain, which has a natural, unique, complex and multifactorial nature [8, 9]. Women with a positive perception of labor is able to tolerate labor pain well [10]. Women's cultural, social and environmental experiences may affect the perception of birth. In addition, personal experiences, expectations of family support and relationships with health professionals affect the perception of labor pain [11]. There are many pharmacological and non-pharmacological methods for the low perception of labor pain. However, due to the risks of pharmacological methods, attention is drawn to the use of non-pharmacological methods [12, 13]. Many methods with physical, psychological and emotional effects such as position, massage, breathing techniques, movement, music, hot/cold application, etc. can be used to reduce the perception of pain [14, 15]. For example, changing position techniques instead of supine position during birth both prevent the baby's heartbeat from being negatively affected and affect the progress of labor by creating gravity support [16].

The use of a birth ball (BB) during the birth process makes the pressure areas less felt compared to the supine or semi fawler positions, increases the mobility of the pelvis and facilitates the rotation of the baby and the progression of the birth [17]. In the active phase of labor, it is recommended to use the BB for at least 20–30 minutes [18, 19]. Considering the women's preference, the active phase of labor can be managed using BB, walking or lying in bed. BB is safe and easy to use for mother and baby health. The women do not need to sit on the BB all the time; she can get up and sit down again. For example, the women's going to the toilet, walking around the room and then sitting on the BB again does not interrupt the practice [18, 20–22]. It is recommended that health professionals use a BB for 30 minutes during the active phase of labor to ensure that the mother has a positive birth experience and is able to tolerate labor pain well. This study is expected to make a significant contribution to existing literature on this topic.

2.1 Aim

This study was applied to evaluate the effect of BB use on birth satisfaction and pain levels of pregnant women during labor.

2.2 Design

This is a randomized controlled trial.

2.3 Study Hypotheses

H1: There is a difference between pain levels of pregnant women who used a BB and not used it during labor.

H2: There is a difference between birth satisfaction levels of pregnant women who used a BB and not used it during labor.

2.4 Participants

The universe of the research consists of pregnant women who gave birth in the delivery room of a state hospital in blinded and accepted to participate in the research. G*Power 3.1.7 program was used to calculate the sample size [23, 24]. In the study of Hollins Martin et al. (2014), it was found that the intervention group (IG) scored 29.19 ± 5.86 and the control group (CG) 26.51 ± 5.13 points from the Birth Satisfaction Scale-Revised [25]. Using these known scores, the sample size was calculated as 85% power, 0.48 effect size, and 0.15 probability of error, 53 in each group, with a total of 106 pregnant women. The study was completed with the IG = 57 and the CG = 54 pregnant women by excluding the pregnant women who left (n = 12) and cesarean delivery (n = 17) during the study.

2.5 Randomization

In order to provide randomization in the study, the pregnant women were divided into two groups using the random numbers table in the simple random sampling method. The researcher wrote “one” number for the CG and “two” number for the IG on two cards. Then the pregnant women were asked to choose one of the two cards. It was decided which group the pregnant women would be according to the number they chose. Since the researcher knew which group the pregnant women were in, only blinding was possible. However, in order to prevent bias, the researcher who collected the data gave codes (first group, second group) to the questionnaire forms of the pregnant women. Afterwards, the statistical researcher used the codes and performed statistical analysis without knowing the group of pregnant women. In the study, the CONSORT scheme was followed during the application (Fig. 1).

Figure 1. Study Design (CONSORT 2010 Flow Diagram)

2.6 Data Collection Method

The data of the study were collected in the delivery room of a state hospital in blinded between March 2020 and December 2021. The pregnant women who came to the delivery room were screened in terms of inclusion criteria, and the women who agreed to participate in the study were included in the study. Inclusion criteria for the study were that the pregnant women agreed to participate in the study, signed the informed consent form, were over 18 years old, had a cervix dilatation of 4 cm, and had no complications preventing vaginal delivery, ≥ 36. gestational week and above, having a singleton pregnancy, not having any extremity problems related to using the BB and performing activities, not being diagnosed with a risky pregnancy, not having a disease diagnosed by a psychiatrist. A situation requiring emergency cesarean section during labor (n = 17), narcotic analgesia applied, pregnancy complications (intrauterine growth retardation, oligohydramnios and polyhydramnios, intrauterine death, placenta previa, fetal distress, preeclampsia, presentation anomalies, macrosomic baby, etc.) pregnant women were excluded from the study.

2.7 Data Collection Method for the Intervention Group (IG);

In data collection times one (Beginning), the data were collected by the researcher in the form of a question-answer face-to-face survey technique. First of all, the aim of the study was explained to the pregnant women and their written consent was obtained. Before the intervention, a “Descriptive Information Form” was performed to the pregnant women. In data collection times two (First Follow-up), the BB intervention was made and followed. Pregnant women with 4 cm cervical dilation admitted to the delivery room were instructed to sit on the BB, pelvic rocking, forward-backward and right-left rocking, forward supported sitting, springing movements for a total of 30 minutes. IG was seated on the BB in an upright position during labor. A stopwatch clock was used to determine these 30 minutes. In order for the pregnant women to continue her balance exercises, she was allowed to sit on the round BB with her knees and hips at an angle of approximately 90°, with an upright spine. The pregnant women were not asked to sit on the ball all the time, and she could take a break for rest or other needs. The duration of use of the BB was completed to 30 minutes. The BB, which is suitable for women's use, was preferred in 45 cm dimensions, and the pilates circle was used as a stabilizer. Under the supervision of the researcher, the pregnant women sat upright on the ball and started to do pelvic rocking, forward-backward and right-left rocking, forward supported sitting, springing movements. Meanwhile, the researcher held the pregnant women's hand. In order for the pregnant women not to lose her balance, the BB was placed on a pilates circle and she was supported by the researcher in making the movements. The pregnant sitting on the BB was not left alone. The researcher supported while sitting or standing on the BB. Obstetric characteristics and pain perception to be followed throughout the delivery process were recorded periodically until the cervix dilation of the pregnant women was 8 cm. The intervention was terminated when the cervix dilation reached 8 cm. At the end of the intervention, the cleaning of the BB was provided by the researcher. The birth process was followed every half hour by the researcher and information about labor was recorded in the “Birth Process Follow-up Form”. The pain level of the women was determined between 0 (no pain) and 10 (unbearable pain) using the “Visual Analog Scale (VAS)”. In data collection times three (Second Follow-up), the “Birth Satisfaction Scale-Revised (BSS-R)” was applied to the women in the first half hour postpartum.

2.8 Data Collection Method for the Control Group (CG);

In data collection times one (Beginning), the data were collected by the researcher in the form of a question-answer face-to-face survey technique. First of all, the purpose of the study was explained to the pregnant women and their written consent was obtained. A “Descriptive Information Form” was applied to the pregnant women. In data collection times two (First Follow-up), only routine supportive midwifery care was given in the CG. CG was laid on the bed in semi fawler or lateral positions during labor. The researcher was with the pregnant women in the CG throughout the birth process. The birth process was followed every half hour by the researcher and information about labor was recorded in the “Birth Process Follow-up Form”. The pain level of the women was determined between 0 (no pain) and 10 (unbearable pain) using the “VAS”. In data collection times three (Second Follow-up), the “BSS-R” was applied to the women in the first half hour postpartum.

2.9 Data Collection Tools

Descriptive Information Form, Birth Process Follow-up Form, VAS and BSS-R were used in the study.

Descriptive Information Form; the form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women [7, 15, 16].

Birth Process Follow-up Form; it was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions about the time when the cervix dilation is 4 cm and the following follow-up hours, dilatation, fetal heartbeat, whether there is using of oxytocin, contraction duration and frequency [20, 26, 27].

Visual Analog Scale (VAS); it is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). A 10 cm vertical form was used in the study. Pain level was evaluated with VAS during each follow-up of the pregnant women.

Birth Satisfaction Scale-Revised (BSS-R); the short form of the scale was revised by Martin et al. in 2016 to evaluate the birth satisfaction levels of women. [28]. Serhatlıoğlu et al. conducted the Turkish validity and reliability study in 2018. The scale consists of 10 items and a minimum of 0 and a maximum of 40 points can be obtained. The items of the scale are in a 5-point Likert type and are scored as strongly agree (4 points)-strongly disagree (0 points). High scores obtained from the scale indicate that the level of birth satisfaction increases. The scale has reverse items. The scale has three sub-dimensions: "Quality of Care", "Women's Attributes" and "Stress Experienced". Serhatlıoğlu et al. determined the total Cronbach’s alpha value of the scale as 0.71 in their study. [29]. In our study, the total Cronbach’s alpha value of the scale was calculated as 0.81.

2.10 Statistical analysis

Analysis of the research data was carried out on the computer with the Statistical Package for Social Science (SPSS) 20.0 package program. The introductory information of the pregnant women was given as number and percentage distributions. Descriptive and obstetric characteristics of pregnant women were compared with Yates Chi-square test. It was used t test in independent groups (Mann Whitney-U test in non-parametric conditions) to determine the difference between the introductory information and scale scores of the pregnant women. And it was used the t test in independent groups (Mann Whitney-U test in non-parametric conditions) to examine the difference between the scale scores of the pregnant women who were IG and CG. It was analyzed by chi-square analysis about the descriptive and birth process information of the pregnant women who were IG and CG. The values in the birth process follow-up of pregnant women who were IG and CG were evaluated with one-way analysis of variance (Friedman Analysis of Variance in non-parametric conditions). The statistical significance of the data was evaluated at the p < 0.05 level.

2.11 Ethics

Ethical approval

was obtained from (Blinded committee of name) Faculty of Health Sciences Ethics Committee for Non-Interventional Clinical Investigations (Date: blinded Number: blinded). Written informed consent was obtained from the pregnant women who participated in the study. The information obtained from pregnant women who left (n = 12) and had cesarean section (n = 17) during the study were destroyed in front of their eyes. The Clinical Trials number is blinded.

The mean age of the pregnant women participating in our study was 28.47 ± 5.98 years in the IG and 28.55 ± 4.68 years in the CG. There was no statistically significant difference between them (p = 0.936). The mean week of gestation was 39.24 ± 1.22 for the IG and 38.40 ± 0.78 for the CG, and a statistically meaningful divergence was noted. (p < 0.001). According to the Body Mass Index (BMI) classification, 35% of the participants in the IG and CG were in the obese group. It was determined that there was no difference between the descriptive characteristics of the participants in the IG and CG before the application. A statistically significant disparity was discovered among gestational weeks and the number of pregnancies in the IG and CG (Table 1).

Table 1

Comparison of Descriptive and Obstetric Characteristics of Pregnant Women in the Intervention and Control Groups (n = 111)
	Intervention Group (n = 57)		Control Group (n = 54)		X²	p
Variables	n	%	n	%
BMI groups during pregnancy
Normal weight 18.50-24.99	10	17.5	6	11.1	1.017	0.601
Overweight 25.00-29.99	27	47.4	29	53.7
Obese ≥ 30.00	20	35.1	19	35.2
Education Status
4 years and below	11	19.3	7	13.0	5.381	0.068
4 to 11 years	36	63.2	44	81.5
12 years and above	10	17.5	3	5.6
Working Status
Yes	10	17.5	4	7.4	1.747	0.186
No	47	82.5	50	92.6
Health Insurance
Yes	47	82.5	48	88.9	0.482	0.488
No	10	17.5	6	11.1
Monthly Income Status of the Family
Income less than expenses	11	19.3	13	24.1	2.193	0.334
Income equals expense	44	77.2	41	75.9
Income more than expense	2	3.5	0	0.0
Gestational Weeks
36 to 38 weeks	13	22.8	28	51.9	8.834	0.003
39 to 41 weeks	44	77.2	26	48.1
Number of Pregnancy
One pregnancy (Primiparous)	20	35.1	7	13.0	6.221	0.013
Two or more pregnancies (Multiparous)	37	64.9	47	87.0
Note: In the table, p values < 0.05 are shown in bold.

The incoming part of the fetus is the head in all pregnant women included in the study. No statistically significant difference was found in the variables of fetal heart rate, oxytocin use and contraction frequency of the pregnant women in the IG and CG at the beginning, during the first and second follow-up. It was determined that 27% of the pregnant women were given oxytocin in the beginning follow-up, 45% in the first follow-up, and 63% in the second follow-up. It was determined that the cervix dilatation levels of the pregnant women in the IG were higher than the CG during the first and second follow-up, and the difference between them was statistically significant. When the contraction times of pregnant women are examined; it was found that the contraction time was shorter in the IG compared to the CG at the beginning and at the first follow-up, and there was no difference between them at the second follow-up. It is seen that the pain scores of the pregnant women in the IG were lower during the first and second follow-up compared to the CG, and the difference was statistically significant (Table 2).

Table 2

Comparison of the Results of the Birth Process of the Pregnant Women
Variables	Beginning	First Follow-up	Second Follow-up
Fetal Heart Rate
Intervention (Mean ± SD)	144.24 ± 6.79	145.38 ± 6.95	143.01 ± 7.38
Control (Mean ± SD)	145.48 ± 6.95	148.07 ± 9.68	141.88 ± 10.60
p*	0.281	0.098	0.547
Cervix Dilatation
Intervention (Mean ± SD)	4.24 ± 0.50	7.01 ± 1.23	8.89 ± 1.81
Control (Mean ± SD)	4.40 ± 0.63	6.27 ± 1.73	7.88 ± 1.48
p*	0.141	0.011	< 0.001
Using Oxytocin
Intervention (%)	10.8	22.5	34.0
Control (%)	16.2	22.5	29.0
p**	0.214	0.947	0.950
Contraction Frequency (minutes)
Intervention (Mean ± SD)	9.00 ± 7.56	6.78 ± 5.72	6.00 ± 5.32
Control (Mean ± SD)	7.68 ± 5.61	6.42 ± 6.21	5.46 ± 4.34
p*	0.306	0.749	0.590
Contraction Time (seconds)
Intervention (Mean ± SD)	15.80 ± 13.64	22.12 ± 18.89	33.76 ± 28.83
Control (Mean ± SD)	25.09 ± 11.63	36.11 ± 16.64	41.55 ± 13.13
p*	< 0.001	< 0.001	0.077
Pain Score
Intervention (Mean ± SD)	5.05 ± 2.14	6.40 ± 1.96	7.54 ± 1.81
Control (Mean ± SD)	5.37 ± 1.81	7.22 ± 1.83	8.44 ± 1.25
p*	0.402	0.026	0.004
t test in Independent Groups, Chi-Square Yates Test, Note: p values < 0.05 are shown in bold.*

None of the babies included in the study in the postpartum period were taken to the intensive care unit. The duration of the active phase of labor in the IG was shorter than in the CG, a statistically significant variation was observed across them. It was determined that there was no difference between the birth weight of the baby and the 1st and 5th APGAR scores of the pregnant women in the IG and CG. It was found that the BSS-R total score, the sub-dimensions of the quality of care, women’s attributes and stress experienced during labor of the pregnant women in the IG were higher than the CG, and the difference between them was significant (Table 3).

Table 3

Comparison of the Postpartum Period Results and Birth Satisfaction Levels of the Pregnant Women
	Intervention (n = 57)	Control (n = 54)	p*
Variables	Mean ± SD	Mean ± SD
Duration of Active Phase (hours)	3.36 ± 1.36	3.92 ± 1.28	0.029
Baby's Birth Weight (grams)	3328.10 ± 369.90	3249.25 ± 340.61	0.246
APGAR Score at
1st minute	8.49 ± 0.92	8.61 ± 0.68	0.439
5th minute	9.59 ± 0.56	9.75 ± 0.43	0.089
BSS-R Total	24.73 ± 5.70	20.12 ± 3.61	< 0.001
Sub-dimensions of BSS-R
Quality of Care	13.57 ± 2.52	12.29 ± 0.90	0.001
Women’s Attributes	3.33 ± 1.79	2.59 ± 1.20	0.013
Stress Experienced	7.82 ± 2.63	5.24 ± 2.78	< 0.001
t test in Independent Groups, Note: p values < 0.05 are shown in bold.*

Our study was evaluated the effect of BB use on birth satisfaction and pain levels of pregnant women during labor. The descriptive features of the participants in the IG and CG were similar. However, there was a difference between the characteristics of the gestational week and the number of pregnancies of the participants in the IG and CG. Vaginal birth occurs when the baby or mother is physiologically ready. For this reason, there may have been differences in the gestational weeks at birth. In addition, it is thought that the number of women with two or more pregnancies is high because of the higher probability of vaginal delivery in multiparous pregnant women. Despite randomization, it is seen that there are more multiparous pregnancies in the CG.

In our study, it is seen that the contraction times of the pregnant women in the IG were shorter at the beginning and at the first follow-up, and there was no statistical difference in the second follow-up, but the mean contraction time of the CG was higher. The difference in the study may be due to the duration of the contraction at the beginning. Literature studies have shown that there is no difference between IG and CG in terms of contraction duration and intervals between contractions [26, 30]. The use of the BB in the active phase did not affect the frequency of contractions.

The most striking result of the study is that cervical dilatation was higher in the IG compared to the CG in the first and second follow-ups. In addition, the duration of the active phase was shorter in the IG than in the CG. It was thought that the use of a BB in the active phase shortens the delivery time and causes an increase in cervical dilatation due to the force of gravity. Contrary to our study, Taavoni et al. (2011) found that the use of the BB had no effect on the duration of the active phase [26]. In similar studies, it was determined that the cervix dilatation increased and the duration of the first and second birth stages decreased [5, 31]. Another study using a BB and birth chart found that the duration of the first stage of labor was shorter [27]. In another study, it was stated that the use of a BB reduces the duration of the first stage of labor [20]. It was concluded that the use of the BB, which was used during the active phase of labour, advanced the labour and shortened its duration [5, 32].

According to the results of the study, it was determined that the pain level of the pregnant women in the IG, who used a 30-minute BB during the active phase of labor, was lower than the pregnant women in the CG. In similar studies, it has been shown that using a BB during the active phase of labor is effective in reducing labor pain [21, 26]. In the meta-analysis studies, they determined that the use of a BB in the first stage of labor is an effective tool in reducing labor pain [18, 21, 22]. Wu et al. (2022), in their study where they used a BB and birth chart, determined that the pregnant women had more self-control compared to the CG, and they had less pain and anxiety during labor [27]. There are many factors (oxytocin use, operative deliveries, etc.) that affect labor pain. In our study, the IG and CG were similar in terms of using oxytocin. In a similar study, it was stated that the rate of oxytocin use was not different in the IG and CG, and the pain level of the IG was lower [20].

In addition, in the study of Hau et al. (2012), it was determined that most of the women who used a BB after delivery were satisfied [20]. In a randomized controlled study, pregnant women who used a BB had higher perceptions of birth control and satisfaction with the birth experience [33]. In our study, it was determined that there was a difference between the mean scores of the total BSS-R, the sub-dimensions of quality of care, women’s attributes and stress experienced during labor of the pregnant women in the IG with CG. In a study comparing the use of a BB and pharmacological pain relief methods, it was found that the satisfaction level was higher in the group using a BB [34]. In another study, the use of a BB positively affected the level of birth satisfaction [31].

In our study, it was determined that there was no difference between the fetal heart rate, birth weight of the baby and APGAR scores at the 1st and 5th minutes of the pregnant women in the IG and CG. In other words, it can be said that the use of a BB in the first stage of labor does not affect the health indicators of the baby. In the study of Hau et al. (2012), it was determined that there was no difference between the IG and CG of the baby's birth weight and APGAR scores [20].

4.1 Limitations

The study was carried out in the delivery room of a state hospital in blinded. Therefore, it cannot be generalized to the universe. In addition, the physician decided to use oxytocin according to the condition of the pregnant women during the delivery. The dose of oxytocin used differs for each pregnant woman. Therefore, data on oxytocin dose were not compared.

4.2 Implication for practice

The freedom of movement of the pregnant women, the encouragement of walking, the use of methods such as the BB or birth dance provide benefits for both the pregnant women and the fetus. The use of a BB is an effective, non-pharmacological, inexpensive, easy-to-use method for pregnant women to cope with labor pain. The skills of health professionals need to be developed so that the BB can be used safely for mother and baby in delivery rooms. Pregnant women should be informed about the use of a BB during labor and should be encouraged to use it. Continuous support of the pregnant women by at least one health professional and not being left alone during delivery will make the use of the BB safe. In addition, training during pregnancy so that pregnant women can move on the BB during delivery will facilitate adaptation during delivery.

According to the results of the study, the use of a BB during the active phase of labor was reduced the pain level of pregnant women during labor and was increased the level of labor satisfaction. The duration of the active phase of labor was shorter in the group in which the BB was used, and the cervix dilatation of the pregnant women was higher than in the CG. The use of a BB in the first stage of labor was not affected the health indicators of the baby.

BB: Birth Ball

IG: Intervention Group

CG: Control Group

VAS: Visual Analog Scale

BSS-R: Birth Satisfaction Scale-Revised

BMI: Body Mass Index

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Competing Interests

The authors have no relevant financial or non-financial interests to disclose.

Authors Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Yasemin ERKAL AKSOY, Şerife ÇELİMLİ and Sema DERELİ YILMAZ. The first draft of the manuscript was written by Yasemin ERKAL AKSOY, Şerife ÇELİMLİ and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Ethical Approval

Ethical approval was obtained from Selcuk University Faculty of Health Sciences Ethics Committee for Non-Interventional Clinical Investigations (Date: 26.02.2020 Number: 2020/285). Written informed consent was obtained from the pregnant women who participated in the study. The information obtained from pregnant women who left (n=12) and had cesarean section (n=17) during the study were destroyed in front of their eyes. The Clinical Trials number is NCT05312502. Clinical Trials registration link: https://clinicaltrials.gov/ct2/show/NCT05312502

Acknowledgments

We would like to thank all pregnant women who agreed to participate in the study.

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Effect of using a birth ball on birth satisfaction and pain in pregnant women during labor: a randomized controlled trial

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Abstract

Purpose

Methods

Results

Conclusion

Figures

1 INTRODUCTION

2 METHODS

2.1 Aim

2.2 Design

2.3 Study Hypotheses

2.4 Participants

2.5 Randomization

2.6 Data Collection Method

2.7 Data Collection Method for the Intervention Group (IG);

2.8 Data Collection Method for the Control Group (CG);

2.9 Data Collection Tools

2.10 Statistical analysis

2.11 Ethics

3 RESULTS

4 DISCUSSION

4.1 Limitations

4.2 Implication for practice

5 CONCLUSION

Abbreviations

Statements & Declarations

References

Status:

Version 1