- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433637
Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother (NST)
Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research
Objective: The research was conducted to determine the effect of music and nutrition played together with motivational video on non-stress test (NST) result and mother's anxiety level.
Method: The study was conducted as a randomized controlled clinical trial. The sample of the study consisted of 360 pregnant women, two experimental and one control group (120 pregnant women in each). In the study, pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure. The second experimental group was provided to eat fruit juice and cake before NST, and the video created with a similar content was given about the developments and changes occurring in the mother and fetus during pregnancy, and was watched for about 15-20 minutes during the NST procedure accompanied by music that provided relaxation. The data of the study were collected by using the Participant Presentation Form, NST evaluation form and State Anxiety Inventory.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Battalgazi
-
Malatya, Battalgazi, Turkey, 44280
- İnonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being 18 or over
- Being pregnant more than 32 weeks gestation,
- Having at least one live birth,
- Having had NST before,
Exclusion Criteria:
- Having any risk factor (preeclampsia, IUGG, early membrane rupture, getational diabetes etc.) during pregnancy
- Urinary contraction after NST,
- It is a cardiovascular disease diagnosed in the fetus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nutrition Group
Pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure.
|
Cake+fruit juice experiment group, pregnant were allowed to consume fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST.
|
Experimental: Video Group
The video, which contains information about the developments and changes occurring in the mother and the fetus during pregnancy, was watched for 15-20 minutes during the NST procedure, accompanied by music that provided relaxation.
|
Music with motivational video experimental group, pregnant women were provided with fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST.
During this waiting period, the researchers were informed about the development and changes in the body and the fetus specific to the gestational week and NST.
Later, NST was applied, and during the procedure, the pregnant women were watched with music that provides relaxation with the video regarding the fetal development appropriate for the gestational week and changes in the mother.
|
No Intervention: Control Group
No intervention was applied to the pregnant women in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of nutrition
Time Frame: 1 month
|
questionnaire NST Findings Registration Form As Reactive NST; The test result was accepted as reactive NST in the presence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed and was 15 beats / minute more than the baseline beat. As nonreactive NST; The absence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed, was 15 beats / minute more than the baseline beat, or 160 beats / minute and above continuous fetal tachycardia in the presence of severe variable decelerations and late decelerations. In case of development, the result was evaluated as nonreactive NST. |
1 month
|
Effect of music with motivational video
Time Frame: 1 month
|
scale State Anxiety Scale The state anxiety part of the scale consisting of two parts was used. Answer options on both scales consisting of twenty questions can get points from 1 to 4. There are direct and inverted expressions in the scales. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten reversed expressions in the WHO and these are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The total score value obtained from the scale varies between 20 and 80. The increase in the score obtained from the scale indicates that the level of anxiety is high. |
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülçin N NACAR, PhD, Inonu universitesi
Publications and helpful links
General Publications
- Taşhan ST, Çoşkun Eİ, Nacar G, Erci B. Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research. Complementary Therapies in Medicine....
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- gulcin nacar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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