Pain Perceived by Women During Episiotomy Repair

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134376
• Other study ID #: AYDIN ADNAN MENDERES UNUVERSTY
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2021
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth
• Virtual Reality

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.

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Institute of Health Sciences ile	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

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