AzTrials
AzTrials

Episiotomy WoundNCT05955716

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

A study testing Virtual reality glasses in people with Episiotomy Wound, run by Özlem Çiçek at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Episiotomy Wound
What is being tested?
Virtual reality glasses
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Apr 2022to 20 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Özlem Çiçek

    Izmir, 35360

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Relaxation Exercise Applied With Virtual Reality Glasses on Episiotomy-induced Perineal Pain Score and Fear: A Single-Blind Randomized Controlled Study

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.

Read the detailed description

This research is a single-blind, randomized controlled experimental study with pre-post and control groups. The population of the study consisted of pregnant women who applied to the Delivery Room in İzmir Bakırçay University Çiğli Training and Research Hospital Travay Birth Postpartum Service. The data pool could not be created because the sample was composed of women who applied for childbirth. In this randomized controlled trial, block randomization was applied. Because when simple randomization is applied, there may be a large difference between the numbers of subjects in the two groups when the study is completed. As the difference between the number of pregnant women in the virtual reality glasses and control groups grows, the reliability of the statistical analysis will decrease. Simple randomization is not recommended in cases where the sample size is less than 200. Although it was planned to take 38 experimental and 38 control group samples that met the inclusion criteria, the block randomization was carried out on 100 people, taking into account the exclusion criteria from the sample.

The randomization of the sample was made using the "random number generation program (Research Randomizer)". Intervention and control groups were formed by performing the randomization process by an impartial researcher who was not involved in the research. While it was known by the researchers in which group the pregnant women were, unilateral blindness was provided by not informing the pregnant women about the groups they were in. Since it is recommended in the literature that each step of randomized controlled trials should be performed according to the Consolidated Standards of Reporting Trials (CONSORT), this study was also conducted according to CONSORT. The type 1 error level of the study was determined as 5% (p=o.o5), the type II error level was 0.20 (80% power) and the effect size was 0.3 (moderate). Data were collected between December 2022 and May 2023. Data collection takes an average of 15 minutes.

Virtual Reality Glasses Group:

Pregnant women in the virtual reality glasses group who agreed to participate in the study and watch a relaxation video with virtual reality glasses were expected to answer the questions in the socio-demographic and obstetric information form during the latent phase of labor. Afterwards, they were asked about how many points of pain and fear they would experience on the VAS during the episiotomy incision and repair, on a scale of 0-10. After this form was answered, a relaxation video was watched with virtual reality glasses during the episiotomy incision and repair. After these procedures, as soon as the episiotomy incision and episiotomy repair were completed, virtual reality glasses were removed and the score of pain and fear they experienced was asked. They were asked to rate the pain and fear they experienced, giving a score between 0-10.

Control Group:

Pregnant women who agreed to participate in the study and who would be in the control group were expected to answer the questions in the socio-demographic and obstetric information form during the latent phase of labor. Afterwards, they were asked to score an estimated 0-10 score for pain and fear levels with VAS during episiotomy incision and repair. After this form was answered, no intervention was made during the episiotomy incision and repair, except routine practice. After these procedures, as soon as the episiotomy incision and episiotomy repair were completed, they were asked about the score of pain and fear they experienced. They were asked to rate the pain and fear they experienced, giving a score between 0-10.

Hypotheses:

  1. H0-Relaxation exercise performed with virtual reality glasses does not affect the perineal pain score experienced while performing the episiotomy incision. H1- Relaxation exercise performed with virtual reality glasses reduces the perineal pain score experienced while performing the episiotomy incision.
  2. H0-Relaxation exercise performed with virtual reality glasses does not affect the perineal pain score experienced during episiotomy suturing. H1- Relaxation exercise with virtual reality glasses reduces the perineal pain score experienced during episiotomy suturing.
  3. H0-Relaxation exercise performed with virtual reality glasses does not affect the fear score experienced while performing the episiotomy incision. H1- Relaxation exercise performed with virtual reality glasses reduces the fear score experienced while applying the episiotomy incision.
  4. H0- Relaxation exercise performed with virtual reality glasses does not affect the fear score experienced during episiotomy suturing.

H1- Relaxation exercise with virtual reality glasses reduces the fear score experienced during episiotomy suturing.

Data collection tool(s):

  • Socio-demographic and Obstetric Information Form This form; age, education level, income level, marital status, body mass index, employment status, occupation, social security, place of residence, cohabitant, obstetric characteristics (pregnancy, birth, abortion, number of curettage), smoking and alcohol use, hospitalization In the application, there are questions about cervical dilatation and effacement level, previous delivery method, episiotomy application status. This form was applied to the women who will be included in the experimental and control groups during the latent phase of labor.
  • Visual Analog Scale Pain Form The Visual Analog Scale is a scale developed by Price et al. in 1983 and is also used in the evaluation of episiotomy pain. VAS is 10 cm long. A minimum of 0 and a maximum of 10 points can be obtained from this scale. A score of zero indicates no pain, and a score of 10 indicates the pain felt at the highest level. The higher the score, the higher the level of pain.
  • Visual Analog Scale Fear Form (VAS-FF) The visual analog scale is a valid and reliable measurement tool to measure other subjective emotions such as mood, in addition to pain. Fear of having an episiotomy is one of these mood changes. VAS is 10 cm long. A minimum of 0 and a maximum of 10 points can be obtained from this scale. She was asked to rate the score of fear experienced during episiotomy incision and repair between 0 and 10 points. A score of 0 indicates no fear, and a score of 10 indicates the highest level of fear. The higher the score, the higher the level of fear experienced.

Statistical method(s) to be used:

Data analysis will be done with SPSS 26 package program. In the evaluation of data; mean, standard deviation and percentage values will be calculated. In order to evaluate the homogeneity of the data according to the groups, the Skewness-Curtosis values will be examined and the tests to be used in the analysis will be decided. A probability value of p<0.05 will be considered statistically significant.

Being tested
Virtual reality glasses
Keywords
virtual reality glasses, episiotomy, pain, fear
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality glassesDevice

    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.

Study groups in NCT05955716
Study groupRoleWhat they receive
Virtual reality glassesExperimentalDuring the episiotomy incision and repair, women in this group watched a relaxation video with virtual reality glasses.
Receives: Device: Virtual reality glasses
Control GroupNo interventionWomen in this group received routine care in the hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately after episiotomy incision

  2. 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.

    Measured: Immediately after episiotomy repair

  3. 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.

    Measured: Immediately after episiotomy incision

  4. 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.

    Measured: Immediately after episiotomy repair

Secondary outcomes (4)
  1. Estimated score of pain experienced during episiotomy incision

    She was asked to estimate how many points of pain he would have experienced during the episiotomy incision. She was asked to answer this question 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 the score indicates that she predicts that the pain she will experience will also be high.

    Measured: Latent phase of birth

  2. Estimated score of pain experienced during episiotomy repair

    She was asked to estimate how many points of pain he would have experienced during the episiotomy repair. She was asked to answer this question 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 the score indicates that she predicts that the pain she will experience will also be high.

    Measured: Latent phase of birth

  3. Estimated score of fear experienced during episiotomy incision

    She was asked to estimate how many points of fear she would have experienced during the episiotomy incision. She was asked to answer this question 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 the score indicates that she predicts that the fear she will experience will also be high.

    Measured: Latent phase of birth

  4. Estimated score of fear experienced during episiotomy repair

    She was asked to estimate how many points of fear she would have experienced during the episiotomy repair. She was asked to answer this question 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 the score indicates that she predicts that the fear she will experience will also be high.

    Measured: Latent phase of birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2023
  2. Study start5 Apr 2022
  3. Primary completion20 May 2023
  4. Study completion20 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05955716
Sponsor's protocol ID
2022-660
Status last verified
Jul 2023
First submitted
23 May 2023
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25999621
  • 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.

    PubMed 31306747
  • 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.

    PubMed 34362032
  • 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.

    PubMed 23565655
  • ACOG Practice Bulletin No. 154: Operative Vaginal Delivery. Obstet Gynecol. 2015 Nov;126(5):e56-e65. doi: 10.1097/AOG.0000000000001147. No abstract available.

    PubMed 26488523
  • 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.

    PubMed 29278232
  • 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.

    PubMed 28176333
  • 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.

    PubMed 18345348
  • 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.

    PubMed 20332511
  • 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.

    PubMed 34121251
  • 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.

    PubMed 32174983

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality glasses in people with Episiotomy Wound, run by Özlem Çiçek at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of pain experienced during episiotomy incision (time frame: Immediately after episiotomy incision). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05955716, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in