Clinical trial NCT05641467: Effect of Virtual Reality Glasses Use During Episiotomy Repair Related
Official title: The Effect Of Watchıng Vıdeo Wıth Vırtual Realıty Glasses On Paın, Anxıety And Satısfactıon Durıng Epızıotomy Repaır
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midwifery
Labor Delivery
Keywords: episiotomy
Virtual Reality
pain
satisfaction
anxiety
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sample size G-power 3.1.9.7. program (Faul et al 2007, Faul et al 2009). Shourab et al. anxiety score average in the study; It was found to be 24.9±1.9 in the intervention group and 21.2±1.1 in the control group. In the light of this study, 0.897 effect size, 0.95 power, 0.05 alpha level and bidirectional hypothesis options were selected in the program, and the number of participants for each group was 34 (Shourab et al 2016). The pregnant women who came to the hospital will evaluate in terms of sample criteria and randomized sampling will divide into two groups. In order to ensure randomization in the study, a random numbers table was created by dividing them into two groups over the number determined on the site https://www.random.org/. Pregnant women will be assigned to groups according to the randomization scheme. Considering that there may be data loss, 20% more was determined and it was planned to study with 82 (41 intervention, 41 control) pregnant women.
Primary purpose: PREVENTION

Brief summary: H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level of pain.

H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety.

H1-3: Watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction.


Eligibility criteria: Inclusion Criteria:

* 18 years and over,

  * Able to speak Turkish and express himself in Turkish,
  * There is no visual or hearing impairment,
  * Being open to communication, spiritually and mentally healthy,
  * 37- 42 weeks of gestation
  * Single pregnancy,
  * Primiparity,
  * Vaginal delivery,
  * Vertexpresentation
  * Media lateral episiotomy,
  * Uncomplicated newborn
  * Newborns between 2500 and 4000 g.
  * Those with episiotomy between 4-8 cm

Exclusion Criteria:

* Presence of obstetric or non-obstetric complications,
* Presence of bleeding requiring urgent measures,
* Administration of sedative drugs before and during episiotomy repair, spinal anesthesia, epidural anesthesia, pudendal block (except for local infiltration of the perineum),
* Lacerations other than episiotomy (anal sphincter injury or Grade 3 or 4 tear),
* Instrument delivery (with vacuum or forceps),
* Postpartum complications in newborns,
* Chronic disease (diabetes mellitus, thyroid disease and hypertension),
* Having a psychiatric diagnosis

Primary outcomes:
measure: Socio-Demographic Data Collection Form
timeFrame: in active phase on labor (4 cm vaginal dilatation)
measure: State-Trait Anxiety Inventory (STAI)-Questionnaire
timeFrame: immediately before repair episiotomy
measure: Visual Analog Scale-Pain (VAS-P)
timeFrame: immediately before repair episiotomy
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)-Questionnaire
timeFrame: immediately after episiotomy repair
measure: Visual Analog Scale-Pain (VAS-P)
timeFrame: immediately after episiotomy repair
measure: Birth Action Follow-up Form
timeFrame: 60 minutes after birth
measure: Satisfaction Evaluation Scale and Form
timeFrame: immediately after episiotomy repair
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Fatma Deniz Sayıner
Study officials:
affiliation: Necmettin Erbakan University, Faculty of Medicine
name: Rüveyde Can
role: PRINCIPAL_INVESTIGATOR
References: