NCT05093283

Brief Summary

When the literature is examined, it is seen that virtual reality glasses are used during medical procedures, have an anxiety-lowering effect and have a reducing effect on the perception of fatigue (20, 7, 10, 11). On the other hand, no study has been found in the literature on the application of virtual glasses to pregnant women who underwent NST. However, in line with the results of the study on virtual glasses, it is thought that the application of virtual glasses will also have a positive effect on the Reactive (Negative) Non-Stress Test result by reducing the anxiety level of pregnant women and increasing fetal movement and fetal cup speed in pregnant women with NST. This study was planned to examine the effects of virtual reality glasses, one of the cognitive behavioral techniques, on fetal movement, fetal heart rate, maternal satisfaction and anxiety level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

September 14, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

Virtual RealityFetal MovementFetal Heart RateAnxiety

Outcome Measures

Primary Outcomes (3)

  • When virtual reality glasses are applied during the Non-Stress test application; (1) increase fetal heart rate and fatal heart rate?

    occurring at least 2 times within a maximum of 20 minutes, at least 15 beats/min more than basal level and lasting for 15 seconds

    through study completion, wenty minutes

  • When virtual reality glasses are applied during the Non-Stress test application; (2) increases maternal satisfaction?

    The scale is a 5-point Likert-type scale consisting of 19 items including nursing care. All items of the Newcastle Nursing Care Satisfaction Scale are positive. In the scoring used to determine the degree of satisfaction, there are statements such as "Not at all Satisfied=1 point, Slightly Satisfied=2 points, Fairly Satisfied=3 points, Very Satisfied=4 points, Extremely Satisfied=5 points". The scores given to the questions of all items marked on the score evaluation scale are added together. The maximum score obtained from the scale is 95, and the minimum score is 19. Evaluation is made by converting the total score obtained from the scale to 100. The increase in the total score obtained from the scale indicates that the patients' satisfaction with nursing is high.

    through study completion, twenty minutes

  • When virtual reality glasses are applied during the Non-Stress test application; Does it reduce the level of maternal anxiety?

    Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.

    through study completion, twenty minutes

Study Arms (2)

Workgroup

EXPERIMENTAL

The probes will be fixed by giving the left lateral position for NST to the pregnant women in the intervention group by the researcher. After providing internet connection with a smart phone for the image, by clicking on youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video watching virtual reality glasses will be provided. The name and surname of the pregnant woman will be written on the NST trace and the trace will be photographed. After the NST process is completed, the NST traces will be evaluated by the researchers.

Device: Virtual Reality Glasses

Control

NO INTERVENTION

Unlike the study group, only video monitoring will not be applied to the pregnant women included in the control group. Other applications will be done in the same way.

Interventions

Virtual Reality Glasses

Workgroup

Eligibility Criteria

Age32 Weeks - 40 Weeks
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 18-45,
  • Healthy pregnant women,
  • No cardiovascular disease diagnosed in the fetus,
  • Having completed the 32nd gestational week,
  • Having eaten at least two hours before the NST procedure,
  • Not smoking or consuming alcohol at least two hours before the NST procedure,
  • Pregnant women who have no communication and visual impairments were included in the study.

You may not qualify if:

  • Pregnant women with fetal distress and for whom emergency intervention is considered by the physician,
  • Pregnant women with impaired NST and needing intervention at that time,
  • Pregnant women with uterine contraction as a result of NST were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TurkishMoHKahramanmarasPH

Kahramanmaraş, Onikişubat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professional

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 26, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

June 30, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations