Skip to main content
OpenTrials
Completed

NCT Number: NCT05641467

Effect of Virtual Reality Glasses Use During Episiotomy Repair Related

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Midwifery Anxiety Disorders Behavior Labor Delivery Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fatma Deniz Sayıner

Konya, 42130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality glasses

Other

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

Primary outcomes

  1. Socio-Demographic Data Collection Form

    Time frame: in active phase on labor (4 cm vaginal dilatation)

    Pregnant Introductory Information Form is a questionnaire prepared by researchers using the literature.

  2. State-Trait Anxiety Inventory (STAI)-Questionnaire

    Time frame: immediately before repair episiotomy

    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.

  3. Visual Analog Scale-Pain (VAS-P)

    Time frame: immediately before repair episiotomy

    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.

Secondary outcomes

  1. State-Trait Anxiety Inventory (STAI)-Questionnaire

    Time frame: immediately after episiotomy repair

    State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ]

  2. Visual Analog Scale-Pain (VAS-P)

    Time frame: immediately after episiotomy repair

    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.

  3. Birth Action Follow-up Form

    Time frame: 60 minutes after birth

    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.

  4. Satisfaction Evaluation Scale and Form

    Time frame: immediately after episiotomy repair

    "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".

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.