- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299214
Music During Non-Stress Testing
December 9, 2025 updated by: GAMZE GOKE ARSLAN, Karamanoğlu Mehmetbey University
The Effect of Music During Non-Stress Testing on Women's Comfort, Vital Signs and Anxiety: A Randomized Controlled Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Central
-
Karaman, Central, Turkey (Türkiye), 70200
- University District, 2076 Street, No: 11
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Group
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
|
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.
|
|
No Intervention: Control Group
Pregnant women were not subjected to any intervention during the NST procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
During Non-Stress Testing on Women's Comfort Level
Time Frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
|
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
Time Frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
|
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
Time Frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
|
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
Time Frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
|
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
Time Frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2025
Primary Completion (Actual)
August 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
November 23, 2025
First Submitted That Met QC Criteria
December 9, 2025
First Posted (Actual)
December 23, 2025
Study Record Updates
Last Update Posted (Actual)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 9, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMBU-NST-2025-01
- 2169 (Ethics decision number) (Other Identifier: Non-Interventional Clinical Research Ethics Committee of the Republic of Türkiye Izmir Bakırçay University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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