Effect of Virtual Reality Glasses Use During Episiotomy Repair Related

Midwifery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641467
• Other study ID #: 0000-0002-1344-0908
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Midwifery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Fatma Deniz Sayiner	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	State-Trait Anxiety Inventory (STAI)-Questionnaire	State-Trait Anxiety Inventory (STAI)-Questionnaire [ Time Frame: up to one hour ]	immediately after episiotomy repair
Secondary	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
Secondary	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
Secondary	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