Fetal Heart FailureNCT05492058
Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
A study testing tactile stimulation group, listen music and virtual reality group in people with Fetal Heart Failure and Fetal Movement Disorder, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Heart Failure, Fetal Movement Disorder
- What is being tested?
- tactile stimulation group, listen music and virtual reality group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2022to 10 Jul 2022
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Not having any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy
- Absence of uterine contraction as a result of NST,
- No cardiovascular disease diagnosed in the fetus,
- Being in the 18-49 age group
Who cannot join
- Any complications in pregnancy and fetus
- Refusal to accept the final test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters: A Randomized Controlled Clinical Trial
The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.
- Conditions
- Fetal Heart Failure, Fetal Movement Disorder
- Being tested
- tactile stimulation group, listen music, virtual reality group
- Keywords
- nursing, fetal health, women, women health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tactile stimulation groupOther
Also called maternal touch
The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.
listen musicOther
Also called music group
Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.
virtual reality groupOther
Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.
| Study group | Role | What they receive |
|---|---|---|
| maternal touch | Experimental | maternal touch Receives: Other: tactile stimulation group; Other: listen music; Other: virtual reality group |
| music group | Experimental | music group Receives: Other: tactile stimulation group; Other: listen music; Other: virtual reality group |
| virtual reality group | Experimental | virtual reality group Receives: Other: tactile stimulation group; Other: listen music; Other: virtual reality group |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate, fetal movement
number
Measured: 20 minutes
Maternal anxiety
STAI State Anxiety Inventory The emotions and behaviors expressed in the State Anxiety Inventory (STAI TX-I) items are answered by marking one of the options such as (1) never, (2) a little, (3) a lot, (4) completely, according to the severity of such experiences. The options in the Anxiety Scale are "almost never"(1), "sometimes"(2), "often"(3), "almost always"(4). Scoring ranges from 1 to 4. In the scale, there are direct or straight and reversed statements. Direct statements indicate negative emotions, reversed statements indicate positive emotions.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start5 Jul 2022
- Primary completion7 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart FailureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Kucukkelepce, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492058
- Sponsor's protocol ID
- Lokman Hekim University
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05492058
- Acronym / sponsor ID
- Lokman Hekim University
- Conditions
- Fetal Heart Failure, Fetal Movement Disorder
- Keywords
- nursing, fetal health, women, women health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 8 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.
The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| maternal touch | Experimental | Other: tactile stimulation group, Other: listen music, Other: virtual reality groupmaternal touch |
| music group | Experimental | Other: tactile stimulation group, Other: listen music, Other: virtual reality groupmusic group |
| virtual reality group | Experimental | Other: tactile stimulation group, Other: listen music, Other: virtual reality groupvirtual reality group |
| control | No intervention | – |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - Not having any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy
- Absence of uterine contraction as a result of NST,
- No cardiovascular disease diagnosed in the fetus,
- Being in the 18-49 age group
Key exclusion criteria (2 listed)
- Any complications in pregnancy and fetus
- Refusal to accept the final test
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 |
|---|---|---|
| tactile stimulation groupAlso: maternal touchThe tactile stimulation group will be asked to touch their own abdomen during the NST procedure. | Other | maternal touch, music group, virtual reality group |
| listen musicAlso: music groupPregnant women in the music group will listen to a song they want with headphones during the NST procedure. | Other | maternal touch, music group, virtual reality group |
| virtual reality groupPregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure. | Other | maternal touch, music group, virtual reality group |
Primary outcome
Fetal heart rate, fetal movement
Time frame: 20 minutes
number
Maternal anxiety
Time frame: 20 minutes
STAI State Anxiety Inventory The emotions and behaviors expressed in the State Anxiety Inventory (STAI TX-I) items are answered by marking one of the options such as (1) never, (2) a little, (3) a lot, (4) completely, according to the severity of such experiences. The options in the Anxiety Scale are "almost never"(1), "sometimes"(2), "often"(3), "almost always"(4). Scoring ranges from 1 to 4. In the scale, there are direct or straight and reversed statements. Direct statements indicate negative emotions, reversed statements indicate positive emotions.
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 8 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Fetal Heart Failure
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Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction (HFPEF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tactile stimulation group, listen music and virtual reality group in people with Fetal Heart Failure and Fetal Movement Disorder, run by Adiyaman University Research Hospital 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 2 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 8 Aug 2022. 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?
Fetal heart rate, fetal movement (time frame: 20 minutes). 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?
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 8 Aug 2022.