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

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT07533448

Acronym / sponsor ID

2025/87

Conditions

Childbirth, Labor Process

Keywords

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

Study type

Interventional

Recruitment status

Completed

Enrolment

106 participants (actual)

Lead sponsor

Agri Ibrahim Cecen UniversityUniversity, hospital or other

Study start

1 Jun 2025 (actual)

Primary completion

1 Oct 2025 (actual)

Study completion

1 May 2026 (actual)

First posted

16 Apr 2026 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

3

Model description

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

Who may qualify

Ages

18 years and older

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
• Results publicationGöncü 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 dataSharing planned: 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.

Related trials for Childbirth

• Not yet recruitingPhase 2/3

  A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial

  Streptococcus Agalactiae Infection, Neonatal Sepsis

• Recruiting

  Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

  Aortic Stenosis Treated With TAVI, Aortic Diseases

• Not yet recruiting

  nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks

  Apnea of Prematurity

• RecruitingPhase 1

  A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity

  Overweight and/or Obesity, Healthy Participants

• Enrolling by invitation

  Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle

  Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.