- 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 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).
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
|
|
Experimental: NADA+MANDALA
Mandala coloring + Nada Yoga music
|
Mandala coloring accompanied by Nada Yoga music
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Baseline, Periprocedural (labor stages: first, second, third)
|
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
Time Frame: Baseline
|
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)
Time Frame: Baseline, Periprocedural (labor stages: first, second, third)
|
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)
Time Frame: Baseline, Periprocedural (labor stages: first, second, third)
|
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
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)
|
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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