The Effects of Using Virtual Reality Glasses During the Non-Stress Test

The Effects of Using Virtual Reality Glasses on Anxiety, Stress, and Fetal Well-Being During the Non-Stress Test

The aim of this study to determine the effect of virtual reality glasses use on anxiety, stress and fetal well-being during the non-stress test. Personal information form was used as data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was used to assess distress, State-Trait Anxiety Inventory (STAI) was used to assessanxiety.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Virtual Reality (VR) glasses

Detailed Description

Material and Method

This research was conducted between between October 2021 and February 2022 in Fethi Sekin City Hospital. When power analysis was performed, the sample size was calculated to be at least 71 women for each group (71 experiments, 71 controls). During the NST procedures, VR glasses were given to the participants in the experimental group by the researcher for the intervention. Data collection form for experimental and control groups before the NST procedures; Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) and State-Trait Anxiety Inventory (STAI) were applied two times before and after NST procedure. After the NST procedures, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• not carrying any risk factors (e.g., preeclampsia, intrauterine growth retardation (IUGR), premature rupture of membranes, gestational diabetes)
• having a singleton pregnancy and no vision problems
• No uterine contraction on the tracing paper at the end of NST
• having eaten at least two hours before NST
• not smoking or drinking alcoholic beverages at least two hours before NST
• having a systolic blood pressure value in the range of 90-140 mmHg and a diastolic blood pressure value in the range of 60-90 mm/Hg
• not having any problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation)
• having no communication barriers.

Exclusion Criteria:

• presence of fetal distress and emergency intervention planned by the physician
• uterine contraction as a result of NST

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Glasses; Virtual Reality (VR) glasses applied group	Other: Virtual Reality (VR) glasses; During the Non Stress Test (NST), the pregnant women in the experimental group watched a video of nature scenery with Virtual Reality (VR) glasses for 10 minutes
No Intervention: Standard of care; group without Virtual Reality (VR) glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety scores	StateTrait Anxiety Scale (STAI The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels	NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Distress scores	Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version): The highest score from the scale is 34, the lowest score is 0. Higher scores indicate higher levels of perceived prenatal distress in the respondent	NST involves 20 minutes of monitoring the fetal heart rate (FHR)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Well-Being scores	NST Registration Form: In the interpretations, the baseline FHR was accepted as 110-160 bpm, variability in a reactive NST was accepted as an FHR of 6-25 bpm, and acceleration was accepted as an elevation in the baseline FHR by at least 15 bpm for at least 15 s. Additionally, deceleration was accepted as a 15-20 bpm drop in comparison to the baseline FHR, and a reactive NST was defined as a result where two or more accelerations peaked at least 15 bpm above the baseline point, each acceleration lasted 15 s or longer, and all these conditions were met within 20 min from the start of the test. A nonreactive NST was defined as the absence of at least two accelerations lasting at least 15 s on the NST tracing paper within 20 min from the start of the test	NST involves 20 minutes of monitoring the fetal heart rate (FHR)

Collaborators and Investigators

• Sponsor: Inonu University
• Collaborators: Inonu University
• Investigators: Principal Investigator: Esra Güney, Inonu University

Publications and helpful links

General Publications

• Sridhar A, Shiliang Z, Woodson R, Kwan L. Non-pharmacological anxiety reduction with immersive virtual reality for first-trimester dilation and curettage: a pilot study. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):480-483. doi: 10.1080/13625187.2020.1836146.

Helpful Links

• Reference link

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; stress; non-stress test; virtual glasses
• Other Study ID Numbers: 2021/2302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: research results will be shared.

Study Data/Documents

1. Informed Consent Form
   Information identifier: Sridhar A, Shiliang Z, Woodson
   Information comments: web site is provided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No