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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711875
• Other study ID #: 2021/2302
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 1, 2022
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (2)

Lead Sponsor	Collaborator
Inonu University	Inönü University

Country where clinical trial is conducted

Turkey, 

References & 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: 10.1080/13625187.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)

External Links

•   Reference link