Back to resultsTactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
Primary Purpose
Fetal Heart Failure, Fetal Movement Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
tactile stimulation group
listen music
virtual reality group
Sponsored by
About this trial
This is an interventional other trial for Fetal Heart Failure focused on measuring nursing, fetal health, women, women health
Eligibility Criteria
Inclusion Criteria:
- - 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
Exclusion Criteria:
- Any complications in pregnancy and fetus
- Refusal to accept the final test
Sites / Locations
- Lokman hekim University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
maternal touch
music group
virtual reality group
control
Arm Description
maternal touch
music group
virtual reality group
Outcomes
Primary Outcome Measures
Fetal heart rate, fetal movement
number
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05492058
First Posted
July 22, 2022
Last Updated
August 4, 2022
Sponsor
Adiyaman University Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05492058
Brief Title
Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Heart Failure, Fetal Movement Disorder
Keywords
nursing, fetal health, women, women health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
maternal touch
Arm Type
Experimental
Arm Description
maternal touch
Arm Title
music group
Arm Type
Experimental
Arm Description
music group
Arm Title
virtual reality group
Arm Type
Experimental
Arm Description
virtual reality group
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
tactile stimulation group
Other Intervention Name(s)
maternal touch
Intervention Description
The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.
Intervention Type
Other
Intervention Name(s)
listen music
Other Intervention Name(s)
music group
Intervention Description
Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.
Intervention Type
Other
Intervention Name(s)
virtual reality group
Intervention Description
Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.
Primary Outcome Measure Information:
Title
Fetal heart rate, fetal movement
Description
number
Time Frame
20 minutes
Title
Maternal anxiety
Description
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.
Time Frame
20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
Any complications in pregnancy and fetus
Refusal to accept the final test
Facility Information:
Facility Name
Lokman hekim University
City
Çankaya
State/Province
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
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