- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414641
Music Listening During NST Monitoring
Effects of Music Listening During Non-Stress Test Monitoring on Fetal Parameters, Maternal Anxiety, Loneliness, and Positive-Negative Affect: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34010
- State University Hospital, Obstetrics Clinic, NST Unit, Istanbul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women attending the NST unit during the study period
- Aged 18 years or older
- Volunteered to participate and provided written informed consent
Exclusion Criteria:
- Inability to read and write Turkish
- Hearing impairment or mental health conditions limiting participation
- Multiple pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Listening During NST
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.
|
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.
|
|
No Intervention: Control Group
Participants received routine NST monitoring in a left lateral position for at least 20 minutes without music.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal State Anxiety
Time Frame: Baseline (pre-NST) and immediately post-NST (same visit)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness (Social and Emotional Loneliness)
Time Frame: Baseline (pre-NST) and immediately post-NST (same visit)
|
Change in loneliness measured using the Social and Emotional Loneliness Scale for Adults - Short Form (SELSA-S). Total scores range from 15 to 105; higher scores indicate greater loneliness. |
Baseline (pre-NST) and immediately post-NST (same visit)
|
|
Positive and Negative Affect
Time Frame: Baseline (pre-NST) and immediately post-NST (same visit)
|
Change in affect measured using the Positive and Negative Affect Schedule (PANAS). Each subscale ranges from 10 to 50; higher positive scores indicate more positive affect and higher negative scores indicate greater negative affect. |
Baseline (pre-NST) and immediately post-NST (same visit)
|
|
Fetal Heart Rate During NST
Time Frame: During NST monitoring (same visit)
|
Fetal heart rate assessed from NST recordings during the monitoring session.
Measured in beats per minute; normal patterns (120-140/min) indicate better fetal well-being.
|
During NST monitoring (same visit)
|
|
Fetal Movement Count During NST
Time Frame: During NST monitoring (same visit).
|
Number of fetal movements recorded by the mother using the event marker during NST monitoring. Higher counts indicate greater fetal activity. |
During NST monitoring (same visit).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: NİLGUN AVCI, Biruni University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Music Listening During NST
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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