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Virtual RealityNCT05134376

Pain Perceived by Women During Episiotomy Repair

A study testing During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music in people with Virtual Reality and Birth, run by Aydin Adnan Menderes University 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
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Trial summary

This research was carried out to evaluate the effect of video and accompanying music played with virtual reality glasses during episiotomy repair on women's perceived pain, vital signs and postpartum comfort during episiotomy repair. This research is a randomized controlled experimental study. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Virtual Reality, Birth
What is being tested?
During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2020to 31 Jan 2021
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 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Turkish,
  • 18 - 35 years
  • primiparous,
  • gestational week 37- 42
  • Mediolateral episiotomy performed
  • pregnant women in active phase Exclusion Criteria
Show all 10Show fewer
  • high risk pregnancy
  • vision and hearing problem
  • with deep laceration
  • 3rd and 4th degree laceration

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Adnan Menderes University Institute of Health Sciences ile

    Aydin

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Virtual Reality Glasses Watched With Music on Pain Perceived by Women During Episiotomy Repair, Vital Signs and Postpartum Comfort

This research was carried out to evaluate the effect of video and accompanying music played with virtual reality glasses during episiotomy repair on women's perceived pain, vital signs and postpartum comfort during episiotomy repair.

This research is a randomized controlled experimental study. The study was conducted on 84 pregnant women, 40 of whom were in the intervention group and 44 were in the control group.

The goals expected to be achieved during the research are; Reducing the perceived pain during episiotomy repair with video and accompanying music played with virtual reality glasses during episiotomy repair Video and accompanying music watched with virtual reality glasses during episiotomy repair increase postpartum comfort The positive effect of video and accompanying music on vital signs during episiotomy repair with virtual reality glasses

Read the detailed description

Workgroup implementation steps Informed Voluntary Consent Form and Pregnancy Introductory Form (the first 8 questions of the pregnant introductory information - labor and episiotomy follow-up form) will be filled in by the researcher, to the pregnant women who were randomized daily to the study and control group by going to the clinic during the research. During the repair of mediolateral episiotomy, the pregnant women included in the study group will be shown the video accompanying the acemaşîrân makam with sterile virtual reality glasses with a view of nature. In the literature, it is stated that the video watched with the acemaşîrân makam and virtual reality glasses reduces pain [6, 7, 21] After the internet connection is established with a smart phone, the video to be clicked on youtube.com will be clicked, Relaxation Project 1 (SBS VR) video and Acemaşiran Ayini Şerifi Ney-Bendir will be selected for the sound, and video and music will be played with virtual reality glasses by pressing the play button[22, 23] Sound and image will be adjusted as the pregnant woman wants. During the study, all pregnant women included in the study will be given the same care and follow-up, apart from watching the video. The video containing nature scenes prepared by the researcher and the acemaşîrân maqam will be watched from the moment the episiotomy is opened to the time when the episiotomy is closed. Numerical pain assessment scale will be applied before, during (during hymen suturing) and 1 hour after the end of mediolateral episiotomy repair. Postpartum comfort scale 4-24th postpartum. The vital signs of the pregnant women in the study group will be recorded by the researcher before and during episiotomy repair (during hymen suturing) and 1 hour after the end of mediolateral episiotomy repair. In episiotomy repair, the time from the first suture to the last column will be recorded. The pregnant woman will be asked how long she perceives the duration of episiotomy.

Control group application steps Unlike the experimental group, only video and music applications will not be applied to the pregnant women included in the control group. Other applications will be made in the same way.

Being tested
During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music
Keywords
Virtual Reality, labor, pain, episiotomy
Medical subject headings
Pain

What participants receive

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

  • During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by MusicOther

    Unlike the experimental group, only video and music application will not be applied to the pregnant women included in the control group. Other applications will be done exactly.

Study groups in NCT05134376
Study groupRoleWhat they receive
WorkgroupExperimentalDuring the repair of the mediolateral episiotomy, the pregnant women included in the study group will be shown a video accompanying the acemaşîrân office with sterile virtual reality glasses with a view of nature.
Receives: Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music
ControlNo interventionUnlike the experimental group, only video and music applications will not be applied to the pregnant women included in the control group. Other applications will be done in the same way.

What is being measured

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

  1. Numerical Pain Rating Scale

    In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

    Measured: before the episiotomy intervention,

  2. Numerical Pain Rating Scale

    In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

    Measured: during the hymen suturing during the episiotomy,

  3. Numerical Pain Rating Scale

    In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

    Measured: one hour after the intervention.

  4. Postpartum Comfort Scale

    The lowest score to be taken on the scale is 34, and the highest score is 170.

    Measured: after 24 hours

  5. Systolic Blood Pressure

    mmHg;

    Measured: before the episiotomy intervention,

  6. diastolic Blood Pressure

    mmHg;

    Measured: before the episiotomy intervention,

  7. Systolic Blood Pressure

    mmHg;

    Measured: during the hymen suturing during the episiotomy,

  8. diastolic Blood Pressure

    mmHg;

    Measured: during the hymen suturing during the episiotomy, n

  9. Systolic Blood Pressure

    mmHg;

    Measured: one hour after the intervention

  10. diastolic Blood Pressure

    mmHg;

    Measured: one hour after the intervention

  11. pulse,

    minute;

    Measured: before the episiotomy intervention, during the hymen suturing during the episiotomy, and one hour after the intervention

  12. espiratory rate

    unit

    Measured: before the episiotomy intervention,

  13. espiratory rate

    unit

    Measured: during the hymen suturing during the episiotomy,

  14. espiratory rate

    unit

    Measured: one hour after the intervention

Timeline

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

  1. First posted24 Nov 2021
  2. Study start1 Nov 2020
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

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
Model description
This research is a randomized controlled experimental study.
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134376
Sponsor's protocol ID
AYDIN ADNAN MENDERES UNUVERSTY
Status last verified
Nov 2021
First submitted
14 Sep 2021
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gokduman Keles M, Altinkaya SO. The Effect of Virtual Reality Accompanied by Music on Women's Perceived Pain, Postpartum Comfort During Episiotomy Repair: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Aug;26(4):e398-e404. doi: 10.1016/j.pmn.2025.02.004. Epub 2025 Mar 12.

    PubMed 40082095

Questions about this trial

What is this clinical trial studying?

A study testing During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music in people with Virtual Reality and Birth, run by Aydin Adnan Menderes University 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 10 inclusion and 0 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 24 Nov 2021. 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?

Numerical Pain Rating Scale (time frame: before the episiotomy intervention,). The study lists 14 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 NCT05134376, which also lists 1 linked publication.

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 24 Nov 2021.

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