Clinical trial NCT05134376: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Birth
Keywords: Virtual Reality
labor
pain
episiotomy
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is a randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: before the episiotomy intervention,
measure: Numerical Pain Rating Scale
timeFrame: during the hymen suturing during the episiotomy,
measure: Numerical Pain Rating Scale
timeFrame: one hour after the intervention.
measure: Postpartum Comfort Scale
timeFrame: after 24 hours
measure: Systolic Blood Pressure
timeFrame: before the episiotomy intervention,
measure: diastolic Blood Pressure
timeFrame: before the episiotomy intervention,
measure: Systolic Blood Pressure
timeFrame: during the hymen suturing during the episiotomy,
measure: diastolic Blood Pressure
timeFrame: during the hymen suturing during the episiotomy, n
measure: Systolic Blood Pressure
timeFrame: one hour after the intervention
measure: diastolic Blood Pressure
timeFrame: one hour after the intervention
measure: pulse,
timeFrame: before the episiotomy intervention, during the hymen suturing during the episiotomy, and one hour after the intervention
measure: espiratory rate
timeFrame: before the episiotomy intervention,
measure: espiratory rate
timeFrame: during the hymen suturing during the episiotomy,
measure: espiratory rate
timeFrame: one hour after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Institute of Health Sciences ile
Study officials:
name: mine gökduman keleş, 1
role: STUDY_DIRECTOR
References: