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

NCT ID: NCT05711875

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study was designed as a randomized controlled trial conducted with experimental and control groups (71 experimental group, 71 control group).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Virtual Reality Glasses

Virtual Reality (VR) glasses applied group

Group Type EXPERIMENTAL

Virtual Reality (VR) glasses

Intervention Type OTHER

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

Standard of care

group without Virtual Reality (VR) glasses

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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İnönü University

UNKNOWN

Sponsor Role collaborator

Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Mevhibe Coban

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ESRA GÜNEY

Role: PRINCIPAL_INVESTIGATOR

Inonu University

Locations

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Inonu University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33140989 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

web site is provided

View Document

Related Links

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Other Identifiers

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2021/2302

Identifier Type: -

Identifier Source: org_study_id

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