NCT05723666

Brief Summary

From the gestation period, labor affects the mother due to both physical and emotional changes. Mothers experience new emotions and experiences since their admission to the delivery room. With the progression of the mother's physiological changes and labor in the delivery room, new situations arise. Although the birth process is a complex process, it can vary from person to person. In the delivery room, many preparations and applications are made for labor. A positive pregnancy and childbirth will affect both the motherhood process and later life periods. Every day, new applications are added to the applications made for the mother to leave the labor satisfied. Virtual reality (VR) glasses application has features such as relaxation, distraction, reducing focus on pain, painful and stressful applications. When the literature is examined, SG glasses are generally focused on pain in the field of women's health. In this study, it is aimed to evaluate the effect of watching videos with SG glasses on the fear of childbirth, NST results and delivery time by using the distraction feature of the mother in the delivery room. The study included mothers who came to Antalya Training and Research Hospital delivery room for vaginal delivery, aged 18-35, had no hearing and vision problems, had an uneventful pregnancy, and had no chronic disease in the fetus or mother. A total of 128 mothers with 64 experimental (32 primiparous, 32 multiparous), 64 control groups (32 primiparous, 32 multipara) and a total of 128 mothers will be included in the study by power analysis. For the randomization of this study, which was planned as a randomized controlled trial, "simple randomization method" stratified sampling, which was admitted to the delivery room and met the inclusion criteria, was used. In the study, mothers in the experimental group will be shown a nature video with SG glasses during the NST procedure. No intervention other than routine delivery room care will be applied to the control group. At the end of the study, it is expected that the level of fear of birth will decrease, the NST will be reactive, and the duration of labor will decrease with the relief of the mothers' SG glasses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

January 20, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

January 21, 2022

Last Update Submit

February 9, 2023

Conditions

Keywords

virtual realityfear of childbirthnon-stress testtime of delivery

Outcome Measures

Primary Outcomes (3)

  • physiological parameter

    reactive NST,

    48 hour

  • Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) Version A and B

    low fear of childbirth

    48 hour

  • physiological parameter

    positive effects on labor time

    2 hour

Study Arms (2)

Group watching video with virtual reality glasses

EXPERIMENTAL

A nature video will be watched with virtual reality glasses.

Other: Group watching virtual reality glasses

Group not watching video with virtual reality glasses

NO INTERVENTION

Virtual reality glasses will not be watched. An intervention will not be applied.

Interventions

A nature video will be watched with virtual reality glasses.

Group watching video with virtual reality glasses

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Verbal communication,
  • Between the ages of 20 and 35,
  • ·-No limitation of hearing and vision,
  • Gestational week between 35-42,
  • Vaginal delivery planned,
  • Do not have any risk factors (premature rupture of membranes, preeclampsia, gestational diabetes, etc.) during pregnancy,
  • No defined cardiovascular disease, anomaly, IUGR (intrauterine growth retardation) in the fetus,

You may not qualify if:

  • Diagnosed with risky pregnancy,
  • Having obstetric complications,
  • Have a previous negative birth history,
  • Having a psychiatric diagnosis,
  • Have a systemic disease,
  • Those who watch the video for less than 20 minutes,
  • Those who went to the cesarean operation,
  • Those with positive or symptomatic COVID-19 PCR test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: There are two Groups with parallel properties. The first group is the experimental group using virtual reality glasses. The second group is the control group without intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 13, 2023

Study Start

January 20, 2022

Primary Completion

June 30, 2022

Study Completion

January 30, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations