Pain Perceived by Women During Episiotomy Repair

NCT05134376 | Completed DMC

• 1 other identifier: AYDIN ADNAN MENDERES UNUVERSTY
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Virtual Reality; Birth

Keywords

Virtual Reality; labor; pain; episiotomy

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

Workgroup

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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

Workgroup

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: primipary
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Institute of Health Sciences ile

Aydin, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40082095 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• mine gökduman keleş, 1

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: episiotomy application and intervention was done by midwives
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Otolaryngology

Model Details: This research is a randomized controlled experimental study.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 24, 2021
• Study Start: November 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)