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

NCT07533448 | Active Not Recruiting DMC

• 1 other identifier: 2025/87
• Study Type: interventional
• Target: 104
• 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 is designed as an experimental study planned to be conducted between May 1, 2025 and May 1, 2026. The study population will consist of pregnant women admitted for live birth to the Obstetrics and Gynecology Department of Ağrı Training and Research Hospital during the study period. The sample size was determined based on a power analysis using an effect size of 0.80 (Cohen's d) obtained from a reference study, a significance level of 5% (α = 0.05), and a statistical power of 80% (1 - β = 0.80). According to the analysis conducted for four independent groups, it was determined that a total of 104 participants should be included in the study, with 26 participants in each group (mandala coloring group, Nada Yoga music group, mandala coloring + Nada Yoga music group, and control group).

Conditions

Childbirth; Labor Process

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) is a one-dimensional instrument used to objectively assess the perception of pain in pregnant women. It enables the quantification of subjective experiences that cannot be directly measured numerically. Hayes and Patterson (1921) proposed that emotional states could be represented along a line. The VAS was first developed and applied by Bond and Pilowsky in 1966. The VAS consists of a 100 mm (10 cm) horizontal line, with one end representing "no pain" (0 = no pain) and the other end representing "the worst imaginable pain" (10 = severe pain). Participants are asked to mark a point on the line that corresponds to the intensity of their pain. The distance between the "no pain" anchor and the marked point is measured using a ruler and recorded in centimeters. The obtained numerical value represents the intensity of pain perceived by the participant. Pain intensity is categorized as follows: 0 cm = no pain, 0.5-3 cm = mild pain,

  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) was originally developed by Hollins Martin and Fleming (2011) and later revised into its short form in 2013. The scale is a 10-item Likert-type instrument. It consists of three subdimensions: quality of care, personal attributes, and stress experienced during labor. The total score ranges from 0 to 40, with higher scores indicating higher levels of maternal satisfaction. The cut-off points are defined as follows: scores \<13 indicate low satisfaction, scores between 14-27 indicate moderate satisfaction, and scores \>28 indicate high satisfaction. The Turkish validity and reliability study of the scale was conducted by Göncü (2015). The Cronbach's alpha coefficient of the scale was reported as 0.74. In the present study, the Cronbach's alpha value was found to be 0.66 (Göncü, 2015; Martin and Fleming, 2011).

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

• State Anxiety Inventory (SAI)

  The State Anxiety Inventory (SAI) was developed by Spielberger et al. in 1964 to assess the state anxiety levels of both normal and clinical populations. The scale was adapted into Turkish by Öner and Le Compte (1983). It is a self-report instrument consisting of short statements. The State Anxiety Inventory is designed to measure how an individual feels at a particular moment and under specific conditions. It consists of 20 items that assess the individual's current level of anxiety. Responses are rated on a 4-point Likert scale based on the intensity of the expressed feelings or behaviors: (1) not at all, (2) somewhat, (3) moderately so, and (4) very much so. The inventory includes 10 reverse-coded items (items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). The total state anxiety score is calculated by subtracting the sum of reverse-coded items from the sum of directly scored items and adding a constant value of 50. The total scores range theoretically

  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)

Study Arms (4)

NADA

EXPERIMENTAL

Nada Yoga music

Other: NADA

MANDALA

EXPERIMENTAL

Mandala coloring

Other: MANDALA

NADA+MANDALA

EXPERIMENTAL

Mandala coloring + Nada Yoga music

Other: MANDALA + NADA

CONTROL

NO INTERVENTION

Control

Interventions

NADA OTHER

Listening to Nada Yoga music

NADA

MANDALA OTHER

Mandala coloring

MANDALA

MANDALA + NADA OTHER

Mandala coloring accompanied by Nada Yoga music

NADA+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: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: April 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)