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

NCT07533448 | Completed DMC

• 1 other identifier: 2025/87
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childbirth; Labor Process

Keywords

Pain during labor; Mandala coloring; Childbirth; Nada Yoga music

Outcome Measures

Primary Outcomes (6)

• Visual Analog Scale (VAS)

  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)

• Personal Information Form

  This form was developed by the researchers based on the relevant literature to collect data on the participants' sociodemographic characteristics.

  Baseline

• Birth Satisfaction Scale-Short Form (BSS-S)

  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)

  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

  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)

• Labor Process Evaluation Form (LPEF)

  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)

Study Arms (3)

NADA

EXPERIMENTAL

Nada Yoga music

Other: NADA

MANDALA

EXPERIMENTAL

Mandala coloring

Other: MANDALA

CONTROL

NO INTERVENTION

Control

Interventions

NADA OTHER

Listening to Nada Yoga music

NADA

MANDALA OTHER

Mandala coloring

MANDALA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study included pregnant women admitted for childbirth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

Ağri İbrahim Çeçen Universty

Ağrı, Ağri, 04100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: All individuals who agreed to participate in the study will be informed about the research, and written informed consent will be obtained using the Informed Consent Form. A copy of the signed consent form will also be provided to the participants. The study data will be collected by the researcher using the following instruments developed in line with the relevant literature: Personal Information Form (PIF), Visual Analog Scale (VAS), State Anxiety Inventory, Birth Satisfaction Scale-Short Form (BSS-S), and the Labor Process Evaluation Form. Participants will be assigned to groups using a randomization method. The control group will receive only routine care. The intervention group will receive the assigned non-pharmacological interventions. All participants in both groups will complete the Personal Information Form (PIF) (Appendix 1), Visual Analog Scale (VAS) (Appendix 2), State Anxiety Inventory (Appendix 4), and Labor Process Evaluation Form (Appendix 5). During the first, secon

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 16, 2026
• Study Start: June 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)