Clinical Trial

Effects of Nada Yoga Music and Mandala Coloring During Labor on Pain, Anxiety, and Maternal Outcomes

Completed
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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.
Protocol Amendment History 3 changes
critical Trial completed 2026-05-28
notable Primary completion pushed: 2025-08-01 -> 2025-10-01 2026-05-28
notable Sponsor changed: Inonu University -> Agri Ibrahim Cecen University 2026-04-23
Trial Details
NCT Number NCT07533448
Lead Sponsor Agri Ibrahim Cecen University
Conditions Childbirth, Labor Process
Enrollment 106 participants
Start Date 2025-06-01
Primary Completion 2025-10-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-10