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Not yet recruiting NCT06663397

Laughter Yoga's Impact on Traumatic Childbirth Preparation

No phase Interventional Maternal Distress Prenatal Stress Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laughter Yoga, Standard Childbirth Preparation Training.
Who it may be relevant to
Registry conditions: Maternal Distress, Prenatal Stress, Pregnancy Related. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects Of Laughter Yoga-Supported Childbirth Preparation Training On Traumatic Birth Perception, Fear Of Birth, Prenatal Depression, And Attachment: A Randomized Controlled Study

Overview

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.

Interventions

  • Other 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
  • 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

Primary outcome measures

  • Traumatic Birth Perception [Time frame: It will be administered three times: before the training, immediately after, and one month later.]
  • Birth Fear [Time frame: It will be administered three times: before the training, immediately after, and one month later.]
  • Prenatal Attachment [Time frame: It will be administered three times: before the training, immediately after, and one month later.]
  • Prenatal Depression [Time frame: It will be administered three times: before the training, immediately after, and one month later.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Ankara University — Ankara

Identifiers

NCT: NCT06663397 · Ankara U

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗