Pain Perceived by Women During Episiotomy Repair

NCT ID: NCT05134376

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-01-31

Brief Summary

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

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.

Conditions

Virtual Reality; Birth

Keywords

Virtual Reality; labor; pain; episiotomy

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Turkish,
• 18 - 35 years
• primiparous,
• gestational week 37- 42
• Mediolateral episiotomy performed

Exclusion Criteria

• high risk pregnancy
• vision and hearing problem
• with deep laceration
• 3rd and 4th degree laceration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

Mine Gokduman Keles

Head of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mine gökduman keleş, 1

Role: STUDY_DIRECTOR

Locations

Adnan Menderes University Institute of Health Sciences ile

Aydin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Gokduman Keles M, Altinkaya SO. The Effect of Virtual Reality Accompanied by Music on Women's Perceived Pain, Postpartum Comfort During Episiotomy Repair: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Aug;26(4):e398-e404. doi: 10.1016/j.pmn.2025.02.004. Epub 2025 Mar 12.

Reference Type: DERIVED

PMID: 40082095 (View on PubMed)

Other Identifiers

AYDIN ADNAN MENDERES UNUVERSTY

Identifier Type: -

Identifier Source: org_study_id