NCT05711875

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

September 7, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 26, 2023

Last Update Submit

September 5, 2023

Conditions

Pregnancy Related

Keywords

Anxietynon-stress teststressvirtual glasses

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Fetal Well-Being scores

    NST involves 20 minutes of monitoring the fetal heart rate (FHR)

Study Arms (2)

Virtual Reality Glasses

EXPERIMENTAL

Virtual Reality (VR) glasses applied group

Other: Virtual Reality (VR) glasses

Standard of care

NO INTERVENTION

group without Virtual Reality (VR) glasses

Interventions

Virtual Reality (VR) glassesOTHER

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

Virtual Reality Glasses

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33140989RESULT

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • ESRA GÜNEY

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: This study was designed as a randomized controlled trial conducted with experimental and control groups (71 experimental group, 71 control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 3, 2023

Study Start

October 15, 2021

Primary Completion

December 21, 2021

Study Completion

February 1, 2022

Last Updated

September 7, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

research results will be shared.

Available IPD Datasets

Informed Consent Form (Sridhar A, Shiliang Z, Woodson)Access

Locations

TU(1)