NCT06663397

Laughter Yoga's Impact on Traumatic Childbirth Preparation

Not yet recruiting NA Last updated 29 October 2024

What this trial tests

NA trial testing Laughter Yoga in Maternal Distress in 68 participants. Not yet recruiting.

Timeline

30 December 2024

Primary endpoint
30 September 2025

31 March 2026

Quick facts

Lead sponsor	Ankara University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	68
Start date	30 December 2024
Primary completion	30 September 2025
Estimated completion	31 March 2026
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Laughter Yoga
• Standard Childbirth Preparation Training

Conditions studied

• Maternal Distress — all drugs for Maternal Distress →
• Prenatal Stress — all drugs for Prenatal Stress →
• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

Ankara University

Who can join

18 and older, female only, with Maternal Distress or Prenatal Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.