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Completed
NCT07533448
Effects of Nada Yoga Music and Mandala Coloring During Labor on Pain, Anxiety, and Maternal Outcomes
Conditions: Childbirth, Labor Process
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 106
Sponsor: Agri Ibrahim Cecen University
Location: Ağri İbrahim Çeçen Universty Ağrı Ağri
Summary
Aim:
The aim of this study is to evaluate the effect of mandala coloring on labor pain, childbirth experience, and maternal satisfaction in pregnant women.
Materials and Methods:
This study was conducted as a randomized controlled trial with a pretest-post test group design including measurements at multiple time points. The study population consisted of pregnant women admitted for vaginal delivery to the labor unit of a hospital between June 1, 2025, and May 1, 2026. Sample size was calculated using the G\*Power 3.1.9.7 program. In the sample size calculation, the Cohen's d = 0.80 value obtained from the reference study was used as the basis and was converted to an approximate effect size of f = 0.40. Analysis performed with a 5% significance level and 80% statistical power indicated that the required minimum sample size for the three groups was 66 participants in total. To prevent potential data loss, support voluntary participation, and increase statistical power, 36 participants were initially planned for each group; however, because one participant in each intervention group was younger than 18 years of age and was therefore excluded, the study was completed with a total of 106 participants in the mandala coloring (n = 35), Nada Yoga music (n = 35), and control (n = 36) groups.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* No communication barriers
* Pregnant women admitted to Ağrı Training and Research Hospital for vaginal delivery
* Willingness to participate in the study
* No contraindication to normal vaginal delivery (e.g., cephalopelvic disproportion)
* Term pregnancy (38-42 weeks of gestation)
* Absence of any chronic disease (e.g., diabetes, hypertension)
* No condition preventing mandala coloring (e.g., hand or finger injuries, structural impairments)
* No condition preventing listening to music (e.g., hearing impairment)
Exclusion Criteria:
* Pregnant women who prefer cesarean delivery despite having no contraindication to vaginal birth
* Failure to respond to the questionnaire items
* Presence of psychiatric disorders (e.g., social phobia, schizophrenia, bipolar disorder)
* Conditions requiring emergency cesarean section during the first stage of labor
Source: ClinicalTrials.gov (NCT07533448). StuddyBuddy aggregates publicly available trial information.