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Completed

NCT Number: NCT05711875

The Effects of Using Virtual Reality Glasses 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.

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Key information

Conditions

Pregnancy Related Anxiety Disorders Mental Disorders

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality (VR) glasses

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

Primary outcomes

  1. Anxiety scores

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

    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

  2. Distress scores

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

    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

Secondary outcomes

  1. Fetal Well-Being scores

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

    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

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Collaborators

  • İnönü University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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