The Effect of Virtual Reality Glasses Applied During Vaginal Incision Suturing on Pain and Satisfaction
The Effect of Virtual Reality Glasses Applied During Episiotomy on Pain and Satisfaction: Single Blind Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey, 46050
- Necip Fazıl City Hospital/ Gynecology and Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group watching video with virtual reality glasses
Women in the intervention group watched a video with virtual reality glasses during the episiotomy.
(25 women)
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watching a video with music with virtual reality glasses.
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No Intervention: Comparisongroup that does not use virtual glasses
The women in the control group were treated with without watching videos during the episiotomy.
(25 women)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 10-15 munites.
|
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.
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10-15 munites.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 5 munites.
|
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.
|
Collaborators and Investigators
Investigators
- Study Chair: Aysel Bülez, Assist. Prof., Kahramanmaraş Sütçü İmam University institute of health sciences.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 135790
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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