Pregnancy RelatedNSTNCT04433637
Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother
A study testing Cake + fruit juice and Video group in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Cake + fruit juice and Video group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 or over
- Being pregnant more than 32 weeks gestation,
- Having at least one live birth,
- Having had NST before,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Pregnancy Related
- Being tested
- Cake + fruit juice, Video group
- Keywords
- Non Stress Test, Motivational Video, Music, Nutrition, State Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cake + fruit juiceDietary supplement
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.
Video groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Group | Experimental | Pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure. Receives: Dietary Supplement: Cake + fruit juice |
| Video Group | Experimental | 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. Receives: Other: Video group |
| Control Group | No intervention | No intervention was applied to the pregnant women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start25 Apr 2018
- Primary completion11 Jul 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin NACAR, Inonu University
- Investigators
- Gülçin N NACAR, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433637
- Sponsor's protocol ID
- gulcin nacar
- Acronym
- NST
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research
- ClinicalTrials.gov ID
- NCT04433637
- Acronym / sponsor ID
- NST / gulcin nacar
- Conditions
- Pregnancy Related
- Keywords
- Non Stress Test, Motivational Video, Music, Nutrition, State Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Nutrition Group | Experimental | Dietary Supplement: Cake + fruit juicePregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure. |
| Video Group | Experimental | Other: Video groupThe 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. |
| Control Group | No intervention | –No intervention was applied to the pregnant women in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 or over
- Being pregnant more than 32 weeks gestation,
- Having at least one live birth,
- Having had NST before,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cake + fruit juiceCake+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. | Dietary supplement | Nutrition Group |
| Video groupMusic 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. | Other | Video Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- BackgroundTaşhan 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....
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülçin N NACAR, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cake + fruit juice and Video group in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nutrition (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.