Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2022
CompletedFirst Submitted
Initial submission to the registry
July 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedAugust 8, 2022
August 1, 2022
2 days
July 22, 2022
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fetal heart rate, fetal movement
number
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.
20 minutes
Study Arms (4)
maternal touch
EXPERIMENTALmaternal touch
music group
EXPERIMENTALmusic group
virtual reality group
EXPERIMENTALvirtual reality group
control
NO INTERVENTIONInterventions
The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.
Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.
Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- Any complications in pregnancy and fetus
- Refusal to accept the final test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lokman hekim University
Çankaya, Ankara, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lokman Hekim University
Study Record Dates
First Submitted
July 22, 2022
First Posted
August 8, 2022
Study Start
July 5, 2022
Primary Completion
July 7, 2022
Study Completion
July 10, 2022
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share