Clinical trial NCT06663397: Laughter Yoga's Impact on Traumatic Childbirth Preparation
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Distress
Prenatal Stress
Pregnancy Related
Keywords: Perception of Traumatic Birth
Fear of Childbirth
Prenatal Depression
Prenatal Attachment
Laughter Yoga
Childbirth Preparation Training
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center parallel-group randomized controlled trial study
Primary purpose: SUPPORTIVE_CARE

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 \&lt; 0.05.


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.

Primary outcomes:
measure: Traumatic Birth Perception
timeFrame: It will be administered three times: before the training, immediately after, and one month later.
measure: Birth Fear
timeFrame: It will be administered three times: before the training, immediately after, and one month later.
measure: Prenatal Attachment
timeFrame: It will be administered three times: before the training, immediately after, and one month later.
measure: Prenatal Depression
timeFrame: It will be administered three times: before the training, immediately after, and one month later.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: İlknur Gönenç, Assoc. Prof. Dr.
role: STUDY_CHAIR
References: