Relaxation Exercise With Virtual Reality Glasses and Episiotomy-induces Perineal Pain and Fear

NCT05955716 | Completed

• 1 other identifier: 2022-660
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to compare the pain and fear scores of women who gave birth for the first time and who did and did not do relaxation exercises with virtual reality glasses during episiotomy incision and episiotomy repair. This research seeks answers to the following questions: Question 1: Does doing relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy incision? Question 2: Does relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy repair? Question 3: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy incision? Question 4: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy repair? A group of participants will be given a relaxation exercise with virtual reality glasses during the episiotomy incision and episiotomy repair. Women in the comparison group will not undergo any intervention during episiotomy incision and repair.

Conditions

Episiotomy Wound

Keywords

virtual reality glasses; episiotomy; pain; fear

Outcome Measures

Primary Outcomes (4)

• Score of pain experienced during episiotomy incision

  She evaluated the pain experienced during the episiotomy incision with the help of a visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in the scores indicates an increase in the level of pain.

  Immediately after episiotomy incision

• Score of pain experienced during episiotomy repair

  She evaluated the pain experienced during the episiotomy repair with the help of visual analog scale. A minimum score of 0 and a maximum score of 10 are taken from this scale, and an increase in scores indicates an increase in the level of pain.

  Immediately after episiotomy repair

• Score of fear experienced during episiotomy incision

  She evaluated the fear experienced during the episiotomy incision with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in score indicates an increase in the level of fear.

  Immediately after episiotomy incision

• Score of fear experienced during episiotomy repair

  She evaluated the fear experienced during the episiotomy repair with the help of visual analog scale. A minimum of 0 and a maximum of 10 points are taken from this scale, and an increase in score indicates an increase in the level of fear.

  Immediately after episiotomy repair

Secondary Outcomes (4)

• Estimated score of pain experienced during episiotomy incision

  Latent phase of birth

• Estimated score of pain experienced during episiotomy repair

  Latent phase of birth

• Estimated score of fear experienced during episiotomy incision

  Latent phase of birth

• Estimated score of fear experienced during episiotomy repair

  Latent phase of birth

Study Arms (2)

Virtual reality glasses

EXPERIMENTAL

During the episiotomy incision and repair, women in this group watched a relaxation video with virtual reality glasses.

Device: Virtual reality glasses

Control Group

NO INTERVENTION

Women in this group received routine care in the hospital.

Interventions

Virtual reality glasses DEVICE

Virtual reality glasses are a device suitable for every mobile phone. It is used to watch the 360 degree video selected from the Youtube program.

Virtual reality glasses

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: • Turkish literacy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Turkish literacy
• Being 18 years or older
• First vaginal delivery
• Unattended vaginal delivery
• Not having a chronic disease
• Not having any complications during pregnancy
• Not using anesthetic drugs during labor
• Agreeing to practice relaxation with virtual reality glasses during the episiotomy incision and suture

You may not qualify if:

• Inability to read and write Turkish
• Incomplete answers to survey and scale questions
• Anesthesia at any stage of birth
• Deciding to have a cesarean delivery from vaginal delivery
• Opting out of participating in the research at any time of the research

Sponsors & Collaborators

• Özlem Çiçek: lead
• Izmir Bakircay University: collaborator

Study Sites (1)

Özlem Çiçek

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (11)

• JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24.

  PMID: 25999621 RESULT

• Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.

  PMID: 31306747 RESULT

• Czech O, Wrzeciono A, Rutkowska A, Guzik A, Kiper P, Rutkowski S. Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 23;10(15):3248. doi: 10.3390/jcm10153248.

  PMID: 34362032 RESULT

• Priddis H, Dahlen HG, Schmied V, Sneddon A, Kettle C, Brown C, Thornton C. Risk of recurrence, subsequent mode of birth and morbidity for women who experienced severe perineal trauma in a first birth in New South Wales between 2000-2008: a population based data linkage study. BMC Pregnancy Childbirth. 2013 Apr 8;13:89. doi: 10.1186/1471-2393-13-89.

  PMID: 23565655 RESULT

• ACOG Practice Bulletin No. 154: Operative Vaginal Delivery. Obstet Gynecol. 2015 Nov;126(5):e56-e65. doi: 10.1097/AOG.0000000000001147. No abstract available.

  PMID: 26488523 RESULT

• Kartal B, Kizilirmak A, Calpbinici P, Demir G. Retrospective analysis of episiotomy prevalence. J Turk Ger Gynecol Assoc. 2017 Dec 15;18(4):190-194. doi: 10.4274/jtgga.2016.0238.

  PMID: 29278232 RESULT

• Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017 Feb 8;2(2):CD000081. doi: 10.1002/14651858.CD000081.pub3.

  PMID: 28176333 RESULT

• Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.

  PMID: 18345348 RESULT

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.

  PMID: 20332511 RESULT

• Solt Kirca A, Korkut Oksuz S, Murat N. The effect of cold application on episiotomy pain: A systematic review and meta-analysis. J Clin Nurs. 2022 Mar;31(5-6):559-568. doi: 10.1111/jocn.15912. Epub 2021 Jun 13.

  PMID: 34121251 RESULT

• Zibanejad S, Miraj S, Rafieian Kopaei M. Healing effect of Quercus persica and Lawsonia inermis ointment on episiotomy wounds in primiparous women. J Res Med Sci. 2020 Feb 20;25:11. doi: 10.4103/jrms.JRMS_251_18. eCollection 2020.

  PMID: 32174983 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Özlem Çiçek, PhD

  Izmir Bakırçay University

  PRINCIPAL INVESTIGATOR

• Gamze Durmazoğlu, PhD

  Izmir Ataturk Training and Research Hospital

  STUDY CHAIR

• Dilek Mamik Aktay, Msc

  Izmir Bakırçay University Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Health Science Faculty Department of Nursing

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 21, 2023
• Study Start: April 5, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)