NCT07452861

Brief Summary

This randomized controlled trial evaluates the effects of listening to ney music during routine non-stress testing (NST) on maternal psychological and physiological responses and fetal reactivity. Maternal anxiety during NST may activate sympathetic pathways and potentially influence fetal heart rate patterns. A total of 126 pregnant women at ≥32 weeks' gestation were randomly assigned to either an intervention group (ney music during NST) or a control group (standard NST care). Maternal state anxiety (State-Trait Anxiety Inventory-State), perceived stress and anxiety (DASS-21), blood pressure, heart rate, respiratory rate, oxygen saturation, and NST reactivity were assessed before and after the procedure. The primary objective is to determine whether ney music reduces acute maternal state anxiety during NST. Secondary objectives include evaluating its effects on autonomic physiological parameters and fetal NST reactivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 1, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

non-stress testmusic interventionmaternal anxietyautonomic regulationfetal reactivityney music

Outcome Measures

Primary Outcomes (1)

  • State Anxiety (STAI-S Score)

    Change in maternal state anxiety measured using the State-Trait Anxiety Inventory-State (STAI-S) before and immediately after the non-stress test (NST).

    Immediately before NST and immediately after NST (20 minutes)

Secondary Outcomes (6)

  • Systolic Blood Pressure (mmHg)

    Before and immediately after NST (20 minutes)

  • Diastolic Blood Pressure (mmHg)

    Before and immediately after NST (20 minutes)

  • Heart Rate (beats per minute)

    Before and immediately after NST (20 minutes)

  • Respiratory Rate (breaths per minute)

    Before and immediately after NST (20 minutes)

  • Oxygen Saturation (%)

    Before and immediately after NST (20 minutes)

  • +1 more secondary outcomes

Study Arms (2)

Ney Music During NST

EXPERIMENTAL

Pregnant women listened to ney music ("Aşkın Yolculuğu") via headphones for 20 minutes during routine non-stress testing (NST).

Behavioral: Ney Music

Standard NST (No Music)

NO INTERVENTION

No Intervention

Interventions

Ney MusicBEHAVIORAL

Listening to prerecorded ney music through headphones during the 20-minute NST procedure.

Ney Music During NST

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥18 years,
  • gestational age ≥32 weeks,
  • singleton pregnancy,
  • absence of known fetal cardiovascular anomalies,
  • no visual or hearing impairments,
  • having eaten at least two hours before the NST,
  • bladder emptied prior to the procedure,
  • voluntary participation.

You may not qualify if:

  • pre-existing maternal medical conditions (hypertension, diabetes, obesity),
  • multiple pregnancy,
  • smoking,
  • known fetal abnormalities or fetal distress,
  • inherited anemia or sexually transmitted infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
KTO Karatay University

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 5, 2026

Study Start

May 30, 2024

Primary Completion

May 30, 2024

Study Completion

August 30, 2024

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations