NCT07414641

Brief Summary

This study evaluated whether listening to music during routine non-stress test (NST) monitoring affects fetal parameters and maternal psychological outcomes. NST is a common prenatal assessment, and some pregnant women may experience anxiety or negative emotions during the procedure. Music listening is a non-pharmacological approach that may improve emotional well-being and potentially influence fetal responses. In this randomized controlled trial, pregnant women who attended an NST unit were assigned either to a music group that listened to music through headphones during NST monitoring or to a control group that received routine NST monitoring without music. Fetal parameters were assessed from NST recordings. Maternal anxiety, loneliness, and positive-negative affect were measured before and after the NST using validated questionnaires. The results of this study aim to inform supportive prenatal care practices and evaluate whether music listening can be used as a simple intervention during NST monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable pregnancy

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

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 6, 2026

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal State Anxiety

    Change in maternal anxiety measured using the State-Trait Anxiety Inventory - State Form (STAI-S). Scores range from 20 to 80; higher scores indicate greater anxiety.

    Baseline (pre-NST) and immediately post-NST (same visit)

Secondary Outcomes (4)

  • Loneliness (Social and Emotional Loneliness)

    Baseline (pre-NST) and immediately post-NST (same visit)

  • Positive and Negative Affect

    Baseline (pre-NST) and immediately post-NST (same visit)

  • Fetal Heart Rate During NST

    During NST monitoring (same visit)

  • Fetal Movement Count During NST

    During NST monitoring (same visit).

Study Arms (2)

Music Listening During NST

EXPERIMENTAL

Participants listened to music through headphones during routine NST monitoring in a left lateral position for at least 20 minutes. The volume was adjusted according to participant preference.

Behavioral: Music Listening During NST

Control Group

NO INTERVENTION

Participants received routine NST monitoring in a left lateral position for at least 20 minutes without music.

Interventions

Participants listened to music through headphones during routine NST monitoring in a left lateral position for at least 20 minutes. The volume was adjusted according to participant preference.

Music Listening During NST

Eligibility Criteria

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

You may qualify if:

  • Pregnant women attending the NST unit during the study period
  • Aged 18 years or older
  • Volunteered to participate and provided written informed consent

You may not qualify if:

  • Inability to read and write Turkish
  • Hearing impairment or mental health conditions limiting participation
  • Multiple pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University Hospital, Obstetrics Clinic, NST Unit, Istanbul

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

Study Officials

  • NİLGUN AVCI

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phD

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 17, 2026

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations