Laughter Yoga's Impact on Traumatic Childbirth Preparation

NCT ID: NCT06663397

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2026-03-31

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.

Conditions

Maternal Distress; Prenatal Stress; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (Laughter Yoga-Supported Childbirth Preparation Training)

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

Group Type: EXPERIMENTAL

Laughter Yoga

Intervention Type: 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

Standard Childbirth Preparation Training

Intervention Type: OTHER

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

Control Group (Standard Childbirth Preparation Training)

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.

Group Type: ACTIVE_COMPARATOR

Standard Childbirth Preparation Training

Intervention Type: OTHER

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

Interventions

Laughter Yoga

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

Intervention Type: OTHER

Standard Childbirth Preparation Training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women aged 18 years and older.
• Pregnant individuals between 20-26 weeks of gestation (Childbirth preparation training should begin by the 20th week of pregnancy according to the recommendations of the Turkish Ministry of Health, and since the training is planned to last 4 weeks, participants will be recruited before entering the third trimester).
• First-time pregnancies.
• Individuals who understand, speak, and can read and write in Turkish.
• Women who consent to participate in the study.

Exclusion Criteria

• Women with high-risk pregnancies (such as placenta previa, history of antepartum bleeding, ruptured membranes, preeclampsia, hypertension, diabetes, or other medical conditions, intrauterine growth restriction, multiple pregnancies, fetal anomalies, or any contraindications for normal vaginal delivery, substance or alcohol dependence, chronic illnesses, etc.).
• Individuals diagnosed with psychiatric disorders.
• Those who have received psychotherapy or medication within the last six months prior to the study.
• Pregnant women with prior training or experience in cognitive awareness-based or mind-body methods.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

İlknur Münevver Gönenç

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlknur Gönenç, Assoc. Prof. Dr.

Role: STUDY_CHAIR

Ankara University

Locations

Ankara University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Serkan Yılmaz, Prof.Dr.

Role: CONTACT

Yilmaz.Serkan@ankara.edu.tr

03123191450

Other Identifiers

Ankara U

Identifier Type: -

Identifier Source: org_study_id