The Effect of Virtual Reality Glasses Applied During Vaginal Incision Suturing on Pain and Satisfaction

NCT05578989 | Completed DMC

• 1 other identifier: 135790
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure. The sample consisted of 50 pregnant woman of whom 25 were in the control group and 25 were determined by randomization among primiparous pregnant woman who met the reasearch's criteria and agreed to participate in the study.

Conditions

Episiotomy; Dehiscence

Keywords

Obstetrics; Episiotomy; Virtual reality; Pain; Satisfaction

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  It is a scale used to measure subjective experiences. In the form of a 0-10 cm ruler, one end of the scale indicates 0 painlessness and the other end 10 indicates the most severe degree of pain intensity. The degree of pain intensity was evaluated by marking the pain perceived by the woman on the ruler.

  10-15 munites.

Secondary Outcomes (1)

• Visual Analogue Scale

  5 munites.

Study Arms (2)

Group watching video with virtual reality glasses

EXPERIMENTAL

Women in the intervention group watched a video with virtual reality glasses during the episiotomy. (25 women)

Device: Virtual reality glasses

Comparisongroup that does not use virtual glasses

NO INTERVENTION

The women in the control group were treated with without watching videos during the episiotomy. (25 women)

Interventions

Virtual reality glasses DEVICE

watching a video with music with virtual reality glasses.

Group watching video with virtual reality glasses

Eligibility Criteria

• Age: 19 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be between the ages of 18-49
• Speak and understand Turkish
• Volunteering to participate in the study
• Being a primiparous (first-time woman) pregnant
• Being in the low pregnancy risk group without obstetric complications (bleeding, unreliable fetal heart rate…) at all stages of delivery
• To have given spontaneous delivery with a medio-lateral episiotomy incision in the hospital at the time of the study.
• Not having vision, hearing and perception problems
• No diagnosis or history of mental illness
• Not having any signs of infection such as vaginal redness, swelling
• Not be allergic to latex and local anesthetic drugs
• No communication problem,

You may not qualify if:

• Apgar score \<7 in 1 minute and 5 minutes
• Having a neonatal anomaly
• Unusual use of lidocaine during episiotomy repair (lidocaine greater than 5 ml 2%)
• Those with headaches

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Necip Fazıl City Hospital/ Gynecology and Children

Kahramanmaraş, 46050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Aysel Bülez, Assist. Prof.

  Kahramanmaraş Sütçü İmam University institute of health sciences.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Midwife

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: October 13, 2022
• Study Start: August 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: August 2, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

TU (1)