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NCT Number: NCT06663397

Laughter Yoga's Impact on Traumatic Childbirth Preparation

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.

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Key information

Conditions

Maternal Distress Pregnancy Related Prenatal Stress

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard Childbirth Preparation Training

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

Primary outcomes

  1. Traumatic Birth Perception

    Time frame: It will be administered three times: before the training, immediately after, and one month later.

    • 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).

  2. Birth Fear

    Time frame: It will be administered three times: before the training, immediately after, and one month later.

    • 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.

  3. Prenatal Attachment

    Time frame: It will be administered three times: before the training, immediately after, and one month later.

    • 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.

  4. Prenatal Depression

    Time frame: It will be administered three times: before the training, immediately after, and one month later.

    • 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Serkan Yılmaz, Prof.Dr.

CONTACT

[email protected]

03123191450

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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