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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04433637
Other study ID # gulcin nacar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2018
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Non Stress Test (NST) has been used frequently in fetal health assessment in recent years due to its easy application, cheapness, reliability and rapid assessment. False negativity rates of NST also cause an increase in cesarean rates. Studies in recent years show that there are methods and factors that increase fetal movements and shorten NST application time. It was observed that nutrient intake, music playing, fetal acoustic vibration application and halogen light applications before NST increased fetal movements and shortened NST time.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date June 1, 2020
Est. primary completion date July 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cake + fruit juice
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.
Other:
Video group
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.

Locations

Country Name City State
Turkey Inonu University Malatya Battalgazi

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Tashan ST, Çoskun EI, 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....

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of nutrition 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
Primary Effect of music with motivational video 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
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