Laughter Yoga's Impact on Traumatic Childbirth Preparation | NCT06663397

NCT06663397

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Brief Summary

This study will be conducted as a single-center, parallel-group, randomized controlled intervention trial to determine the effects of birth preparation training supported by laughter yoga on the perception of traumatic birth, fear of birth, prenatal depression, and attachment in primiparous women. The research population will consist of pregnant women who attend the Pregnancy Clinic of the Department of Obstetrics and Gynecology at Cebeci Medical Faculty, Ankara University. The study will involve two groups: the first group will receive birth preparation training supported by laughter yoga, while the second group will receive standard birth preparation training. A total of 68 pregnant women, 34 in each group, are planned to participate in the study. Data will be collected using the Introductory Information Form, Traumatic Birth Perception Scale, Prenatal Self-Assessment Scale Fear of Birth Subscale, Edinburgh Depression Scale, and Prenatal Attachment Inventory. These instruments will be administered to the participants three times: before the training, immediately after the training, and one month later. The research data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 24. Descriptive statistics (number, percentage, mean, standard deviation, minimum, and maximum values) will be used for data analysis. Independent samples t-test will be employed for comparisons between two independent groups, paired samples t-test will be used for repeated measures, one-way ANOVA will be used for comparisons among more than two groups, and Pearson correlation analysis will be applied for the relationship between two quantitative variables.

When data do not follow a normal distribution, the Mann-Whitney U test will be used for comparisons between two independent groups, the Wilcoxon signed-rank test will be used for repeated measures, the Kruskal-Wallis test will be used for comparisons among more than two groups, and Spearman correlation analysis will be used for the relationship between two quantitative variables. The reliability of the scales used in the study will be determined using Cronbach's alpha coefficient. Statistical significance will be set at p < 0.05.

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group (Laughter Yoga-Supported Childbirth Preparation Training)	Experimental	Similar to the control group, the training will be conducted by the researcher, covering the same content as the standard childbirth preparation training. However, in addition to this, the experimental group will participate in Laughter Yoga sessions lasting 45 minutes each week for a total of 4 sessions. These sessions will include 30 minutes of laughter and breathing exercises, followed by 15 minutes of laughter meditation and relaxation	Other: Laughter Yoga Other: Standard Childbirth Preparation Training
Control Group (Standard Childbirth Preparation Training)	Active Comparator	The sessions will be conducted in groups of 8 participants. Various educational materials, including visual aids, will be used, and the training will involve presentations, direct instruction, video displays, and question-and-answer sessions.	Other: Standard Childbirth Preparation Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laughter Yoga	Other	Laughter Yoga sessions lasting 45 minutes each week for a total of 4 sessions. These sessions will include 30 minutes of laughter and breathing exercises, followed by 15 minutes of laughter meditation and relaxation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Traumatic Birth Perception	• Traumatic Birth Perception Scale: Developed by Yalnız et al. (2016) to assess the level of traumatic birth perception among women of reproductive age, this scale consists of 13 items related to feelings of anxiety, fear, and worry when thinking about childbirth. Scoring ranges from 0 to 10 for each item, with a total possible score of 0 to 130. Higher scores indicate a greater perception of traumatic birth. The Cronbach's alpha reliability coefficient for this scale is 0.89 (Yalnız et al., 2017).	It will be administered three times: before the training, immediately after, and one month later.
Birth Fear	• Prenatal Self-Assessment Scale Birth Fear Subscale: This scale, developed by Lederman (1979), evaluates pregnant women's adjustment to motherhood. The Turkish reliability and validity study was conducted by Beydağ and Mete (2008). The Birth Fear Subscale consists of 10 items, with possible scores ranging from 10 to 40. Higher scores indicate greater fear of childbirth. The Cronbach's alpha reliability coefficient for this subscale is reported as 0.79 in Lederman's study and 0.84 in Beydağ and Mete's study.	It will be administered three times: before the training, immediately after, and one month later.
Prenatal Attachment	• Prenatal Attachment Inventory (PBE): Developed by Müller (1993) and adapted to Turkish by Yılmaz and Beji (2013), this 21-item scale assesses emotional experiences and attachment levels during pregnancy. Scores range from 21 to 84, with higher scores indicating stronger attachment. The Cronbach's alpha for this scale is 0.84 (Yılmaz & Beji, 2013), and it will be administered at the same intervals.	It will be administered three times: before the training, immediately after, and one month later.
Prenatal Depression	• Edinburgh Depression Scale: Developed by Cox et al. (1987), this scale assesses the risk, level, and severity of postpartum depression. The Turkish validity and reliability study was conducted by Engindeniz et al. (1996), with an internal consistency coefficient of 0.79. The scale consists of 10 items rated on a 4-point Likert scale. Although designed for postpartum assessment, it will be used during pregnancy. The Cronbach's alpha coefficients for the three trimesters were 0.82, 0.83, and 0.84, respectively (Bergin et al., 2011).

Eligibility Module

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics