Pain Perceived by Women During Episiotomy Repair

The Effect of Virtual Reality Glasses Watched With Music on Pain Perceived by Women During Episiotomy Repair, Vital Signs and Postpartum Comfort

This research was carried out to evaluate the effect of video and accompanying music played with virtual reality glasses during episiotomy repair on women's perceived pain, vital signs and postpartum comfort during episiotomy repair.

This research is a randomized controlled experimental study. The study was conducted on 84 pregnant women, 40 of whom were in the intervention group and 44 were in the control group.

The goals expected to be achieved during the research are; Reducing the perceived pain during episiotomy repair with video and accompanying music played with virtual reality glasses during episiotomy repair Video and accompanying music watched with virtual reality glasses during episiotomy repair increase postpartum comfort The positive effect of video and accompanying music on vital signs during episiotomy repair with virtual reality glasses

Study Overview

• Status: Completed
• Conditions: Virtual Reality; Birth
• Intervention / Treatment: Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music

Detailed Description

Workgroup implementation steps Informed Voluntary Consent Form and Pregnancy Introductory Form (the first 8 questions of the pregnant introductory information - labor and episiotomy follow-up form) will be filled in by the researcher, to the pregnant women who were randomized daily to the study and control group by going to the clinic during the research. During the repair of mediolateral episiotomy, the pregnant women included in the study group will be shown the video accompanying the acemaşîrân makam with sterile virtual reality glasses with a view of nature. In the literature, it is stated that the video watched with the acemaşîrân makam and virtual reality glasses reduces pain [6, 7, 21] After the internet connection is established with a smart phone, the video to be clicked on youtube.com will be clicked, Relaxation Project 1 (SBS VR) video and Acemaşiran Ayini Şerifi Ney-Bendir will be selected for the sound, and video and music will be played with virtual reality glasses by pressing the play button[22, 23] Sound and image will be adjusted as the pregnant woman wants. During the study, all pregnant women included in the study will be given the same care and follow-up, apart from watching the video. The video containing nature scenes prepared by the researcher and the acemaşîrân maqam will be watched from the moment the episiotomy is opened to the time when the episiotomy is closed. Numerical pain assessment scale will be applied before, during (during hymen suturing) and 1 hour after the end of mediolateral episiotomy repair. Postpartum comfort scale 4-24th postpartum. The vital signs of the pregnant women in the study group will be recorded by the researcher before and during episiotomy repair (during hymen suturing) and 1 hour after the end of mediolateral episiotomy repair. In episiotomy repair, the time from the first suture to the last column will be recorded. The pregnant woman will be asked how long she perceives the duration of episiotomy.

Control group application steps Unlike the experimental group, only video and music applications will not be applied to the pregnant women included in the control group. Other applications will be made in the same way.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey
    • Adnan Menderes University Institute of Health Sciences ile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Turkish,
• 18 - 35 years
• primiparous,
• gestational week 37- 42
• Mediolateral episiotomy performed
• pregnant women in active phase Exclusion Criteria
• high risk pregnancy
• vision and hearing problem
• with deep laceration
• 3rd and 4th degree laceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Workgroup; During the repair of the mediolateral episiotomy, the pregnant women included in the study group will be shown a video accompanying the acemaşîrân office with sterile virtual reality glasses with a view of nature.	Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music; Unlike the experimental group, only video and music application will not be applied to the pregnant women included in the control group. Other applications will be done exactly.
NO_INTERVENTION: Control; Unlike the experimental group, only video and music applications will not be applied to the pregnant women included in the control group. Other applications will be done in the same way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).	before the episiotomy intervention,
Numerical Pain Rating Scale	In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).	during the hymen suturing during the episiotomy,
Numerical Pain Rating Scale	In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).	one hour after the intervention.
Postpartum Comfort Scale	The lowest score to be taken on the scale is 34, and the highest score is 170.	after 24 hours
Systolic Blood Pressure	mmHg;	before the episiotomy intervention,
diastolic Blood Pressure	mmHg;	before the episiotomy intervention,
Systolic Blood Pressure	mmHg;	during the hymen suturing during the episiotomy,
diastolic Blood Pressure	mmHg;	during the hymen suturing during the episiotomy, n
Systolic Blood Pressure	mmHg;	one hour after the intervention
diastolic Blood Pressure	mmHg;	one hour after the intervention
pulse,	minute;	before the episiotomy intervention, during the hymen suturing during the episiotomy, and one hour after the intervention
espiratory rate	unit	before the episiotomy intervention,
espiratory rate	unit	during the hymen suturing during the episiotomy,
espiratory rate	unit	one hour after the intervention

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Director: mine gökduman keleş, 1

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (ACTUAL): November 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: pain; Virtual Reality; labor; episiotomy
• Other Study ID Numbers: AYDIN ADNAN MENDERES UNUVERSTY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No