Pain Perceived by Women During Episiotomy Repair

• ClinicalTrials.gov Identifier: NCT05134376
• Recruitment Status: Completed
• First Posted: November 24, 2021
• Last Update Posted: November 24, 2021
• Sponsor: Aydin Adnan Menderes University
• Information provided by (Responsible Party): Mine Gokduman Keles, Aydin Adnan Menderes University

Tracking Information

• First Submitted Date: September 14, 2021
• First Posted Date: November 24, 2021
• Last Update Posted Date: November 24, 2021
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: January 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 23, 2021)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This research is a randomized controlled experimental study.

Masking: None (Open Label)
Masking Description:

episiotomy application and intervention was done by midwives

Primary Purpose: Supportive Care

Condition

• Virtual Reality
• Birth

Intervention

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.

Study Arms

• 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.
  Intervention: Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 23, 2021): 84
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 31, 2021
• Actual Primary Completion Date: January 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: primipary

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT05134376
• Other Study ID Numbers: AYDIN ADNAN MENDERES UNUVERSTY
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Mine Gokduman Keles, Aydin Adnan Menderes University
• Study Sponsor: Aydin Adnan Menderes University
• Collaborators: Not Provided

Investigators

• Study Director: mine gökduman keleş, 1

• PRS Account: Aydin Adnan Menderes University
• Verification Date: November 2021