Effect of Virtual Reality Glasses Use During Episiotomy Repair Related

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2023-12-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Midwifery Labor Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Video will be watched with virtual reality glasses during episiotomy repair

Views of nature with virtual reality glasses during episiotomy repair.

Group Type EXPERIMENTAL

virtual reality glasses

Intervention Type 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.

Control

It will be perform routine practice who the women in the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Video will be watched with virtual reality glasses during episiotomy repair

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes