NCT07299214

Brief Summary

Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

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

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 23, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

non-stress testmusiccomfortvital signsanxiety

Outcome Measures

Primary Outcomes (5)

  • During Non-Stress Testing on Women's Comfort Level

    Prenatal Comfort Scale (PCS) was used to determine women's comfort level. The short version of the PCS consists of 15 items. Response given to the items are rated on a six-point Likert type scale ranging from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The minimum and maximum possible scores that can be obtained from the PCS are 0 and 75, respectively. The higher the score is the higher the comfort level is.

    Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

  • During Non-Stress Testing on Women's Systolic Blood Pressure Level

    The women's systolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).

    Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

  • During Non-Stress Testing on Women's Diastolic Blood Pressure Level

    The women's diastolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).

    Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

  • During Non-Stress Testing on Women's Diastolic Heart Rate Level

    Heart rate level was determined electronically. Heart rate level was recorded in beats per minute (bpm).

    Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

  • During Non-Stress Testing on Women's Anxiety Level

    State Anxiety Scale (SAS) was used to determine the anxiety level. The scale is a 4-point Likert type, "not at all" (1), "somewhat" (2), "moderately" (3), "very much" (4). The scale consists of 20 items and items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reverse scored. To calculate the total score of the SAS, the total score of the reversed items is subtracted from the total score of the non-reversed items. Then, 50 points, which is the constant value of the state anxiety scale, are added to this score. The result is the score for the overall SAS. The total score varies between 20 and 80. The higher the score is the higher the level of the anxiety is. While a score ranging between 0 and 19 indicates "no anxiety", a score ranging between 20 and 39 indicates mild anxiety, a score ranging between 40 and 59 indicates moderate anxiety, a score ranging between 60 and 79 indicates severe anxiety, and a score of 80 indicates very severe anxiety (Panic).

    Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)

Study Arms (2)

Music Group

EXPERIMENTAL

After the pregnant women were positioned, while the NST procedure was implemented they listened to music for 20-30 minutes. The pregnant women listened to the music on an MP3 player during the application. The duration of the music recorded on the MP3 player was 30 minutes. The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect

Other: Music intervention

Control Group

NO INTERVENTION

Pregnant women were not subjected to any intervention during the NST procedure.

Interventions

The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect.

Music Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipation in the study was restricted based on biological sex. Because the study included pregnant women, biologically female individuals were eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-45 years
  • Completion of at least the 32nd week of gestation
  • No pregnancy-related risk factors (e.g., premature rupture of membranes, preeclampsia, gestational diabetes)
  • No multiple pregnancy
  • Normal blood pressure levels (not ≤80/60 mmHg and not ≥140/90 mmHg)
  • Having eaten at least two hours before the NST procedure
  • No smoking or alcohol consumption for at least two hours before the NST procedure
  • Ability to communicate effectively
  • No hearing impairment
  • Voluntary participation in the study

You may not qualify if:

  • Pregnant women with fetal distress
  • Cases for whom the physician considered emergency intervention necessary
  • Individuals with an impaired NST requiring immediate intervention
  • Individuals with a diagnosed psychiatric disorder
  • Individuals with hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University District, 2076 Street, No: 11

Karaman, Central, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participating pregnant women were not informed of the group they belonged to. Since only the researcher knew the participants' groups, single-blindness was achieved in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Simple randomization method was used in this study. Pregnant women who met the study criteria were randomly assigned to the music or control group with equal probability, independently of any previous assignments, on the day they came to the hospital for their physical examination. The total number of pregnant women determined by the G\*Power analysis was entered into the program at ''https://www.randomizer.org," and randomization was conducted using the program. The assignment of the groups was performed on the computer, and the pregnant women were randomly assigned to the music and control groups. The data of the study were collected from the pregnant women using the face-to-face interview technique at the NST outpatient clinic on the days and hours when the researcher was present in the hospital.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor, Department of Nursing

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 23, 2025

Study Start

June 1, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations