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

NCT ID: NCT05578989

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2022-08-02

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.

Detailed Description

Objective: 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.

Method: The research population consisted of 50 primiparous pregnant women who applied to the delivery room of Necip Fazıl City Hospital Gynecology and Child Additional Service Building between 15 June 2021 and 15 December 2021 for vaginal delivery. Data were collected with the Mother Identification Form and Visual Analogum Scales (VAS) Pain - Satisfaction Evaluation Forms. During the episiotomy repair procedure, 5 ml of lidocaine was administered to the patients in the intervention group; A video with music was watched with virtual reality glasses for an average of 10 minutes, just before starting the process and throughout the process. No application was made to the mothers in the control group, except for 5 ml of lidocaine, which was applied during episiotomy repair. In the evaluation of the data, mean, standard deviation, percentage and number values are given. Student's t test was used to compare normally distributed variables in two groups, and Mann Whitney U test was used to compare non-normally distributed variables in two groups. In testing the variables in different groups and times, repeated measures of variance analysis were applied. Relationships between categorical variables were tested with CI-square test, and relations between non-normally distributed numerical variables were tested with Spearman rank correlation coefficient. SPSS 22.0 Windows version package program was used in the analysis. P<0.05 was considered significant.

Conditions

Episiotomy; Dehiscence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group watching video with virtual reality glasses

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

Group Type: EXPERIMENTAL

Virtual reality glasses

Intervention Type: DEVICE

watching a video with music with virtual reality glasses.

Comparisongroup that does not use virtual glasses

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality glasses

watching a video with music with virtual reality glasses.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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,

• Those with headaches

Exclusion Criteria

• 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%)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Merva Orhan

MSc Midwife

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aysel Bülez, Assist. Prof.

Role: STUDY_CHAIR

Kahramanmaraş Sütçü İmam University institute of health sciences.

Locations

Necip Fazıl City Hospital/ Gynecology and Children

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

135790

Identifier Type: -

Identifier Source: org_study_id