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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Virtual Reality Glasses Applied During Episiotomy on Pain and Satisfaction: Single Blind Randomized Controlled Trial

Conditions
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Episiotomy; Dehiscence

Intervention / Treatment
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* Device: Virtual reality glasses


Participation Criteria
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Eligibility Criteria
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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, 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%) Those who did not meet the inclusion criteria, did not fill out the form and stopped participating in the study. Those with headaches

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group watching video with virtual reality glasses<br>Women in the intervention group watched a video with virtual reality glasses during the episiotomy. (25 women) | Device: Virtual reality glasses<br>* watching a video with music with virtual reality glasses.<br>|
| No Intervention: Comparisongroup that does not use virtual glasses<br>The women in the control group were treated with without watching videos during the episiotomy. (25 women) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | It is a scale used to measure subjective experiences. It was used to assess satisfaction after episiotomy. One end of the scale, in the form of a 0-10 cm ruler, indicates dissatisfaction at all, and the other end of 10 indicates the highest degree of satisfaction. The satisfaction level of the woman was evaluated by marking the number on the ruler. Satisfaction was measured in the first 1-hour period immediately after the episiotomy. | 5 munites. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstetrics, Episiotomy, Virtual reality, Pain, Satisfaction