CClinicalTrials.gg
CompletedNCT07533448Updated Aug 26, 2026

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

An interventional study of NADA and MANDALA in Childbirth and Labor Process, sponsored by Agri Ibrahim Cecen University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Agri Ibrahim Cecen University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Childbirth
  • Labor Process

Keywords

  • Pain during labor
  • Mandala coloring
  • Childbirth
  • Nada Yoga music
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In context

Lead sponsor

Agri Ibrahim Cecen University is the lead sponsor of 39 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    NADA

    Nada Yoga music

    Other: NADA

  • Experimental
    MANDALA

    Mandala coloring

    Other: MANDALA

  • No intervention
    CONTROL

    Control

Interventions

  • OtherNADA

    Listening to Nada Yoga music

  • OtherMANDALA

    Mandala coloring

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, Periprocedural (labor stages: first, second, third)

  2. Personal Information Form

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

    Time frame: Baseline

  3. 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).

    Time frame: Baseline, Periprocedural (labor stages: first, second, third)

  4. 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.

    Time frame: Baseline, Periprocedural (labor stages: first, second, third)

  5. 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.

    Time frame: Periprocedural (labor stages: first, second, third)

  6. 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

    Time frame: Periprocedural (labor stages: third)

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Study locations

1 site
  • Ağri İbrahim Çeçen Universty
    Ağrı, Ağri 04100, Turkey (Türkiye)
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References and documents

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.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be publicly shared due to ethical and confidentiality considerations, as the dataset contains sensitive personal and clinical information. However, de-identified data may be made available from the corresponding author upon reasonable request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07533448
Lead sponsor
Agri Ibrahim Cecen University
Responsible party
NURTEN ÖZÇALKAP (Asistant Professor, Agri Ibrahim Cecen University) — Principal investigator
First posted
Apr 16, 2026
Start date
Jun 1, 2025
Primary completion
Oct 1, 2025
Completion
May 1, 2026
Last update
Aug 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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