NCT07392112

Brief Summary

This study was designed as a randomized controlled trial. Based on the power analysis (Cohen's d = 0.80, α = 0.05, power = 80%), a total of 52 pregnant women were included, with 26 participants in the intervention group and 26 in the control group. Pregnant women who met the inclusion criteria and provided written informed consent were randomly assigned to the groups using a computer-generated randomization method. The intervention group received Nada Yoga music therapy after admission to the delivery room, and the intervention was continued until birth. The therapy consisted of music compatible with the philosophy of Nada Yoga, including relaxing melodies, mantras, and nature sounds, which were delivered via speakers placed in the labor room. The control group received standard obstetric care. Data were collected using the Pregnant Woman Information Form, Labor Follow-up Form, Visual Analog Scale (VAS), and the Spielberger State Anxiety Inventory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 1, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

Labor painAnxietyNada Yoga music therapy

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Before the intervention, when cervical dilatation reached 4-5 cm, the following assessments were conducted in pregnant women in both groups: collection of demographic and obstetric characteristics using the Personal Information Form and Labor Follow-up Form, assessment of pain intensity using the Visual Analog Scale (VAS), and measurement of anxiety levels using the Spielberger State Anxiety Inventory.

    Before the intervention (when cervical dilatation reached 4-5 cm) and after the intervention during the active (4-7 cm) and transition (8-10 cm) phases of labor

Secondary Outcomes (1)

  • Secondary Outcome Measure

    Before the intervention (at 4-5 cm cervical dilatation) and after the intervention during the active (4-7 cm) and transition (8-10 cm) phases of labor

Study Arms (2)

Nada Yoga music therapy

EXPERIMENTAL

Intervention Applied to the Intervention Group This intervention is a behavioral intervention. Participants in the experimental arm receiPregnant women in the intervention group will receive Nada Yoga music therapy after admission to the delivery room. The intervention will be implemented as follows: Selected music: A playlist consisting of special melodies, mantras, and nature sounds compatible with the philosophy of Nada Yoga, which have been proven to have a relaxing effect on brain waves, will be used. Duration of application: Music therapy will continue from the time of admission to the delivery room until birth occurs. Method of application: During this period, the pregnant women will listen to the music through speakers placed in the labor room.Pregnant women in the intervention group will listen to Nada Yoga music via speakers throughout labor after admission to the delivery room, and their pain and anxiety levels will be assessed using the VAS and the State Anxiety Inventory.

Other: Nada Yoga music therapy

Control Group

NO INTERVENTION

Procedure Applied to the Control Group Pregnant women in the control group will not receive any music therapy, and standard obstetric care procedures will be followed. This group will be monitored throughout the labor process without any additional relaxing music or sound interventions.Pregnant women in the control group will receive only routine obstetric care throughout labor, without any music or additional relaxing interventions, and their pain and anxiety levels will be assessed using the VAS and the State Anxiety Inventory.

Interventions

Nada Yoga music therapy

Nada Yoga music therapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant woman
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having no impairment in communication skills
  • Voluntarily agreeing to participate in the study
  • Being between 37-42 weeks of gestation
  • Planning a vaginal delivery
  • Having no high-risk factors during pregnancy
  • Having a singleton pregnancy
  • Having a vertex fetal presentation

You may not qualify if:

  • Individuals with communication problems
  • Those who do not volunteer to participate in the study
  • Pregnant women before 37 weeks of gestation or after 42 weeks of gestation
  • Pregnant women with a planned cesarean delivery
  • Pregnant women with gestational diabetes, preeclampsia, or other obstetric risk factors
  • Those with multiple pregnancies
  • Those with non-vertex fetal presentations (e.g., breech, transverse)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sinop University

Sinop, Sinop, 57000, Turkey (Türkiye)

Location

sinop University

Sinop, Sinop University, 57000, Turkey (Türkiye)

Location

Related Publications (1)

  • Misto, R. (2016). Yoga of Sound music therapy system: techniques acting on autonomic nervous system. Nordic Journal of Music Therapy. https://doi.org/10.1080/08098131.2016.1180115. Misto, R. (2020). Therapeutic Musical Scales: Theory and Practice. , 6, 1-1. https://doi.org/10.21926/OBM.ICM.2102019. Singh, P. (2021). Exploring Current Music Therapy Practices in India. Voices: A World Forum for Music Therapy. https://doi.org/10.15845/voices.v21i3.3246. Sundar, S. (2005). Can Traditional Healing Systems Integrate With Music Therapy -

    RESULT

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Sibel YÜCETÜRK, pHd

    SinopUniversity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Due to the nature of the intervention (audible music), participants and healthcare providers could not be blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is designed as a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2026

First Posted

February 6, 2026

Study Start

May 1, 2025

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual patient data obtained in this study will not be shared with other researchers in order to protect the privacy and confidentiality of the participants.

Locations