Clinical trial NCT05711875: The Effects of Using Virtual Reality Glasses During the Non-Stress Test
Official title: The Effects of Using Virtual Reality Glasses on Anxiety, Stress, and Fetal Well-Being During the Non-Stress Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Anxiety
non-stress test
stress
virtual glasses
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: İnönü University
First posted: 2023-02-03
Enrollment: 71
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study was designed as a randomized controlled trial conducted with experimental and control groups (71 experimental group, 71 control group).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety scores
timeFrame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
measure: Distress scores
timeFrame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Secondary outcomes:
measure: Fetal Well-Being scores
timeFrame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: ESRA GÜNEY
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.