High Risk PregnancyNCT05495789
The Effect of Virtual Reality and Music in High-Risk Pregnants on Non-Stress Test
A study testing Virtual Reality and Music in people with High Risk Pregnancy, run by NESLİHAN YILMAZ SEZER at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to determine the effects of virtual reality and listening to music during the NST procedure on NST parameters, anxiety and satisfaction in high-risk pregnant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- Virtual Reality and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2023to 10 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being at the 32nd and above gestational week
- Pregnant women with a single fetus
- Have eaten at least two hours before the NST procedure
- No cardiovascular disease diagnosed in the fetus,
- The participants ate at least 2 h before the NST, urinated immediately before the NST and did not smoke or drink alcohol for at least 2 h before the NST.
- Those diagnosed with high-risk pregnancy by a physician (pregnancy-induced hypertension, preeclampsia, eclampsia, gestational diabetes, premature rupture of membranes, pregnancy large or small for gestational age, intrauterine growth retardation, polihydramnios, oligohydramnios, premature birth threat, maternal age 35 age and above, maternal body mass index over 30 (obesity)
- Not having vision and hearing problems
Who cannot join
- Pregnant women with major medical (cardiac, renal or neurological diseases) or mental illnesses (psychosis, neurosis, addictions, etc.)
- healty pregnant women
- multiple pregnancy
- having a fetus with anomaly,
- Pregnant women with fetal distress and for whom emergency intervention is considered by the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality and Music Application on Non-Stress Test Parameters, Anxiety and Satisfaction During Non-Stress Test in High-Risk Pregnants
Aim: The aim of this study is to determine the effects of virtual reality and listening to music during the NST procedure on NST parameters, anxiety and satisfaction in high-risk pregnant.
Hypotheses H01 In the NST process, there is no difference between the NST parameters of the virtual reality group and the NST parameters of the control group.
Read more
H02 In the NST procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group.
H03 There is no difference between the satisfaction score of the group in which virtual reality was applied in the NST procedure and the satisfaction score of the control group.
H04 In the NST process, there is no difference between the NST parameters of the group to which the virtual reality is applied and the NST parameters of the musical group.
H05 In the NST procedure, there was no difference between the anxiety score of the group in which virtual reality was applied and the anxiety score of the music group.
H06 In the NST process, there is no difference between the satisfaction score of the group to which the virtual reality was applied and the satisfaction score of the music group.
H07 In NST operation, there is no difference between the NST parameters of the music group and the NST parameters of the control group.
H08 In the NST procedure, there was no difference between the anxiety score of the music group and the anxiety score of the control group.
H09 There is no difference between the satisfaction score of the music group and the satisfaction score of the control group in the NST procedure.
Read the detailed description
The study will be carried out in three different groups. The practice will start with meeting the high-risk pregnant who apply to the NST. After the women are evaluated in terms of eligibility criteria for the research, the high-risk pregnant who are eligible will be informed about the research and written informed consent will be obtained from the high-risk pregnant who accept. The random distribution of high-risk pregnant to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the high-risk pregnant in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After the NST device is connected and, the high-risk pregnant included in the experimental group will be made to watch a video lasting an average of 40 minutes with virtual reality glasses until the procedure is completed.
Music Group In addition to the routine procedure, the high-risk pregnant women in the music group of the research will listen to the relaxing music used in the virtual reality application with headphones.
Control Group The high-risk pregnants in the control group of the study will not be subjected to any treatment other than the routine procedure.
- Conditions
- High Risk Pregnancy
- Being tested
- Virtual Reality, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
A relaxing video will be watched with virtual reality glasses.
MusicOther
Relaxing music will be played by wearing headphones.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | In addition to the routine procedure, virtual reality glasses will be applied to the high-risk pregnant in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After the NST device is connected and, the high-risk pregnant included in the experimental group will be made to watch a video lasting an average of 40 minutes with virtual reality glasses until the procedure is completed. Receives: Other: Virtual Reality |
| Music Group | Experimental | In addition to the routine procedure, the high-risk pregnant women in the music group of the research will listen to the relaxing music used in the virtual reality application with headphones. Receives: Other: Music |
| Control Group | No intervention | The high-risk pregnants in the control group of the study will not be subjected to any treatment other than the routine procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Measured: immediately before the NST procedure and immediately after the NST procedure
the degree of satisfaction
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
Measured: immediately after the NST procedure
Non-Stress Test Parameters/ basal fetal heart rate
It is the average fetal heart rate sustained over a 10-minute period and 120-160 beats/minute is normal.
Measured: immediately after the NST procedure
Non-Stress Test Parameters: number of accelerations
Acceleration an increase in fetal heart rate.
Measured: immediately after the NST procedure
Non-Stress Test Parameters/ number of decelerations
Deceleration is the slowing of fetal heart rate seen on the monitor during contractions.
Measured: immediately after the NST procedure
Non-Stress Test Parameters/ reactive nst
Reactive NST; It is a normal result showing that accelerations occur at least twice within a maximum of 20 minutes, are at least 15 beats/min more than the basal level and continue for 15 seconds.
Measured: immediately after the NST procedure
Non-Stress Test Parameters / Test time (minutes) for reactive NST
Time until reactive NST result is obtained.
Measured: immediately after the NST procedure
Non-Stress Test Parameters / Non-reaktif NST
Non-reactive NST; An abnormal result showing that less than two of the accelerations that are at least 15 beats/min above baseline occur in a 40 min time frame.
Measured: immediately after the NST procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start9 Jan 2023
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- NESLİHAN YILMAZ SEZER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NESLİHAN YILMAZ SEZER, Ankara University
- Investigators
- AYKAN YÜCEL, Prof.Dr., Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495789
- Sponsor's protocol ID
- 12/125
- Status last verified
- May 2023
- First submitted
- 9 Aug 2022
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Music Application on Non-Stress Test Parameters, Anxiety and Satisfaction During Non-Stress Test in High-Risk Pregnants
- ClinicalTrials.gov ID
- NCT05495789
- Acronym / sponsor ID
- 12/125
- Conditions
- High Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- NESLİHAN YILMAZ SEZERUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 10 Aug 2022 (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.
Aim: The aim of this study is to determine the effects of virtual reality and listening to music during the NST procedure on NST parameters, anxiety and satisfaction in high-risk pregnant.
Hypotheses H01 In the NST process, there is no difference between the NST parameters of the virtual reality group and the NST parameters of the control group.
H02 In the NST procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group.
H03 There is no difference between the satisfaction score of the group in which virtual reality was applied in the NST procedure and the satisfaction score of the control group.
H04 In the NST process, there is no difference between the NST parameters of the group to which the virtual reality is applied and the NST parameters of the musical group.
H05 In the NST procedure, there was no difference between the anxiety score of the group in which virtual reality was applied and the anxiety score of the music group.
H06 In the NST process, there is no difference between the satisfaction score of the group to which the virtual reality was applied and the satisfaction score of the music group.
H07 In NST operation, there is no difference between the NST parameters of the music group and the NST parameters of the control group.
H08 In the NST procedure, there was no difference between the anxiety score of the music group and the anxiety score of the control group.
H09 There is no difference between the satisfaction score of the music group and the satisfaction score of the control group in the NST procedure.
Detailed description
The study will be carried out in three different groups. The practice will start with meeting the high-risk pregnant who apply to the NST. After the women are evaluated in terms of eligibility criteria for the research, the high-risk pregnant who are eligible will be informed about the research and written informed consent will be obtained from the high-risk pregnant who accept. The random distribution of high-risk pregnant to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the high-risk pregnant in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After the NST device is connected and, the high-risk pregnant included in the experimental group will be made to watch a video lasting an average of 40 minutes with virtual reality glasses until the procedure is completed.
Music Group In addition to the routine procedure, the high-risk pregnant women in the music group of the research will listen to the relaxing music used in the virtual reality application with headphones.
Control Group The high-risk pregnants in the control group of the study will not be subjected to any treatment other than the routine procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual RealityIn addition to the routine procedure, virtual reality glasses will be applied to the high-risk pregnant in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After the NST device is connected and, the high-risk pregnant included in the experimental group will be made to watch a video lasting an average of 40 minutes with virtual reality glasses until the procedure is completed. |
| Music Group | Experimental | Other: MusicIn addition to the routine procedure, the high-risk pregnant women in the music group of the research will listen to the relaxing music used in the virtual reality application with headphones. |
| Control Group | No intervention | –The high-risk pregnants in the control group of the study will not be subjected to any treatment other than the routine procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being at the 32nd and above gestational week
- Pregnant women with a single fetus
- Have eaten at least two hours before the NST procedure
- No cardiovascular disease diagnosed in the fetus,
- The participants ate at least 2 h before the NST, urinated immediately before the NST and did not smoke or drink alcohol for at least 2 h before the NST.
Key exclusion criteria (5 listed)
- Pregnant women with major medical (cardiac, renal or neurological diseases) or mental illnesses (psychosis, neurosis, addictions, etc.)
- healty pregnant women
- multiple pregnancy
- having a fetus with anomaly,
- Pregnant women with fetal distress and for whom emergency intervention is considered by the physician
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 |
|---|---|---|
| Virtual RealityA relaxing video will be watched with virtual reality glasses. | Other | Virtual Reality Group |
| MusicRelaxing music will be played by wearing headphones. | Other | Music Group |
Primary outcome
Change in anxiety
Time frame: immediately before the NST procedure and immediately after the NST procedure
STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
the degree of satisfaction
Time frame: immediately after the NST procedure
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
Non-Stress Test Parameters/ basal fetal heart rate
Time frame: immediately after the NST procedure
It is the average fetal heart rate sustained over a 10-minute period and 120-160 beats/minute is normal.
Non-Stress Test Parameters: number of accelerations
Time frame: immediately after the NST procedure
Acceleration an increase in fetal heart rate.
Non-Stress Test Parameters/ number of decelerations
Time frame: immediately after the NST procedure
Deceleration is the slowing of fetal heart rate seen on the monitor during contractions.
Non-Stress Test Parameters/ reactive nst
Time frame: immediately after the NST procedure
Reactive NST; It is a normal result showing that accelerations occur at least twice within a maximum of 20 minutes, are at least 15 beats/min more than the basal level and continue for 15 seconds.
Non-Stress Test Parameters / Test time (minutes) for reactive NST
Time frame: immediately after the NST procedure
Time until reactive NST result is obtained.
Non-Stress Test Parameters / Non-reaktif NST
Time frame: immediately after the NST procedure
Non-reactive NST; An abnormal result showing that less than two of the accelerations that are at least 15 beats/min above baseline occur in a 40 min time frame.
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 12 May 2023.
- 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.
AYKAN YÜCEL, Prof.Dr. study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Music in people with High Risk Pregnancy, run by NESLİHAN YILMAZ SEZER 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 7 inclusion and 5 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 12 May 2023. 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?
Change in anxiety (time frame: immediately before the NST procedure and immediately after the NST procedure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2023.