- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533448
Effects of Nada Yoga Music and Mandala Coloring During Labor on Pain, Anxiety, and Maternal Outcomes
Evaluation of the Effects of Nada Yoga Music and Mandala Coloring During Childbirth on Pain, Anxiety, Labor Process, and Maternal Satisfaction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ağri
-
Ağrı, Ağri, Turkey (Türkiye), 04100
- Ağri İbrahim Çeçen Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: CONTROL
Control
|
|
|
Experimental: NADA
Nada Yoga music
|
Listening to Nada Yoga music
|
|
Experimental: MANDALA
Mandala coloring
|
Mandala coloring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Information Form
Time Frame: Baseline
|
This form was developed by the researchers based on the relevant literature to collect data on the participants' sociodemographic characteristics.
|
Baseline
|
|
Labor Process Evaluation Form
Time Frame: Periprocedural (labor stages: first, second, third)
|
The Labor Process Evaluation Form (Appendix 5) is a tool developed by the researcher based on the relevant literature (Tuncay, 2024) to assess the childbirth process of the participants.
|
Periprocedural (labor stages: first, second, third)
|
|
Visual Analog Scale (VAS)
Time Frame: Baseline, Periprocedural (labor stages: first, second, third)
|
The Visual Analog Scale (VAS) is It is a unidimensional measurement tool used to evaluate labor pain intensity.
Pain level is determined by measuring the point marked by the participant on a 10-cm line ranging from 0 (no pain) to 10 (unbearable pain).
Higher scores indicate more severe pain perception.
The VAS is widely used as a valid and reliable method for the quantitative evaluation of pain perception, particularly in pregnant women and women during labor
|
Baseline, Periprocedural (labor stages: first, second, third)
|
|
Birth Satisfaction Scale-Short Form (BSS-S)
Time Frame: Baseline, Periprocedural (labor stages: first, second, third)
|
The Birth Satisfaction Scale-Short Form (BSS-S) This scale, developed by Martin and Fleming and revised by Martin and Martin, is a 10-item, 5-point Likert-type instrument designed to evaluate women's perceptions of childbirth.
The Turkish validity and reliability study was conducted by Göncü and Karahan.
Scores obtained from the scale range from 0 to 40, with higher scores indicating greater satisfaction; in the Turkish adaptation, scores were classified as low (<13), moderate (14-27), and high (≥28) satisfaction.
Items are scored between 0 and 4, and items 2, 4, 7, and 8 are reverse coded.
Although the original scale included three subdimensions, the Turkish validity study identified two subdimensions with eigenvalues above 1: Personal Attributes & Stress (PAS) and Quality of Care (QC).
|
Baseline, Periprocedural (labor stages: first, second, third)
|
|
State Anxiety Inventory (SAI-I)
Time Frame: Baseline, Periprocedural (labor stages: first, second, third)
|
The State Anxiety Inventory (SAI-I) It was developed to evaluate anxiety level at a specific moment.
The scale was adapted into Turkish by Öner and Le Compte.
The scale is a self-report instrument that evaluates the individual's current emotional state.
It consists of a total of 20 items, and items are scored on a 4-point Likert scale (not at all = 1, somewhat = 2, very much = 3, completely = 4).
Obtained scores range from 20 to 80, with higher scores indicating higher anxiety levels.
|
Baseline, Periprocedural (labor stages: first, second, third)
|
|
Labor Process Evaluation Form (LPEF)
Time Frame: Periprocedural (labor stages: third)
|
Labor Process Evaluation Form (LPEF): It was prepared by the researcher in accordance with the literature to evaluate clinical and experiential characteristics associated with the labor process in the participants.
The form includes labor stages, labor duration, and basic clinical findings related to the mother and newborn
|
Periprocedural (labor stages: third)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Göncü S. Adaptation of the Birth Satisfaction Scale-Short Form into Turkish and Determination of Its Psychometric Properties. Institute of Health Sciences, Department of Midwifery. Master's Thesis, Karabük: Karabük University; 2015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/87
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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