Effect of Virtual Reality Glasses Use During Episiotomy Repair Related

The Effect Of Watchıng Vıdeo Wıth Vırtual Realıty Glasses On Paın, Anxıety And Satısfactıon Durıng Epızıotomy Repaır

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.

Study Overview

• Status: Completed
• Conditions: Midwifery; Labor Delivery
• Intervention / Treatment: Other: virtual reality glasses

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42130
    • Fatma Deniz Sayıner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video will be watched with virtual reality glasses during episiotomy repair; Views of nature with virtual reality glasses during episiotomy repair.	Other: virtual reality glasses; OculusQuest 2 128GB brand virtual reality glasses will be used in our research. OculusQuest 2 128GB is the original all-in-one gaming system for virtual reality. It can only be used as desired with the VR headset and controllers. It adapts to its environment. In this way, it can be played standing and sitting in small and large areas. When glasses will be used on another pregnant women within the scope of COVID-19 measures, disinfection will be provided with 'DiverseyOxivir Plus (hydrogen peroxide)' surface disinfectant. Before the episiotomy repair, the video glasses will be opened, the video will be adjusted to suit the woman. In order for the repair method to be the same for all women, It will be planned to use absorbable, synthetic, braided, sterile surgical thread produced from 1-0 polyglactin.; Other Names: Video will be watched with virtual reality glasses during episiotomy repair
No Intervention: Control; It will be perform routine practice who the women in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-Demographic Data Collection Form	Pregnant Introductory Information Form is a questionnaire prepared by researchers using the literature.	in active phase on labor (4 cm vaginal dilatation)
State-Trait Anxiety Inventory (STAI)-Questionnaire	State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ] STAI was used to measure the anxiety level of pregnant women. It was developed by Spielberger et al. (Spielberger et al., 1970) and Öner and Le Compte conducted a Turkish validity and reliability study of the scale (Öner & LeCompte, 1983). In the scale, individuals are provided to express their feelings with 40 expressions. With the state anxiety scale, it is possible to determine how the individual feels at the moment and in the conditions, and with the trait anxiety scale, how he feels outside of the current situation and conditions. The scale is a 4-point Likert type.The last score obtained shows the anxiety level of the individual. High scores from the scale indicate an increased level of anxiety, low scores indicate a decrease.	immediately before repair episiotomy
Visual Analog Scale-Pain (VAS-P)	The VAS-P, which is used to evaluate the severity of pain, is a 10 cm long horizontally or vertically drawn ruler, starting with "No pain (0)" and ending with "Unbearable pain (10)". The woman is asked to show the point on this line that corresponds to the intensity of pain she feels. The distance between the marked point and the starting end of the line (0=no pain) is measured in centimeters and the numerical value found shows the severity of the patient's pain (Hayes and Patterson 1921). VAS-P is accepted as a safe, valid and usable measurement tool in repeated measurements. In this study, horizontally prepared VAS-P was used to assess pain intensity.	immediately before repair episiotomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory (STAI)-Questionnaire	State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ]	immediately after episiotomy repair
Visual Analog Scale-Pain (VAS-P)	The VAS-P, which is used to evaluate the severity of pain, is a 10 cm long horizontally or vertically drawn ruler, starting with "No pain (0)" and ending with "Unbearable pain (10)". The woman is asked to show the point on this line that corresponds to the intensity of pain she feels. The distance between the marked point and the starting end of the line (0=no pain) is measured in centimeters and the numerical value found shows the severity of the patient's pain (Hayes and Patterson 1921). VAS-P is accepted as a safe, valid and usable measurement tool in repeated measurements. In this study, horizontally prepared VAS-P was used to assess pain intensity.	immediately after episiotomy repair
Birth Action Follow-up Form	This form includes the week of pregnancy, the height and weight of the pregnant woman, hemoglobin values, induction status, how long the birth stages last, the time of opening the episiotomy, the time of starting the repair, the ending time of the repair, the length of the episiotomy, the baby's Apgar score, the baby's weight.	60 minutes after birth
Satisfaction Evaluation Scale and Form	"Visual Analog Scale (VAS)" has been adapted to similar usage principles. The VAS is a scale that is evaluated by individuals on a horizontal or vertical line of 10 cm or 100 mm, with one end indicating that the individual is "very good" and the other end is "very bad".	immediately after episiotomy repair

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Rüveyde Can, Necmettin Erbakan University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): December 24, 2023
• Study Completion (Actual): December 24, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pain; satisfaction; anxiety; Virtual Reality; episiotomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Adrenergic Agents; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Adrenergic Uptake Inhibitors; Sympathomimetics; Methamphetamine
• Other Study ID Numbers: 0000-0002-1344-0908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No