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Completed

NCT Number: NCT07533448

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

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.

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Key information

Conditions

Childbirth Labor Process

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ağri İbrahim Çeçen Universty

Ağrı, Ağri, 04100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

NADA

Other

Listening to Nada Yoga music

Mandala

Other

Mandala coloring

Primary outcomes

  1. 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

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Agri Ibrahim Cecen University

Other

Registry information

Official study title

Evaluation of the Effects of Nada Yoga Music and Mandala Coloring During Childbirth on Pain, Anxiety, Labor Process, and Maternal Satisfaction

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Jul 10, 2026

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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