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Completed

NCT Number: NCT05134376

Pain Perceived by Women During Episiotomy Repair

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

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Key information

Conditions

Virtual Reality Birth Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adnan Menderes University Institute of Health Sciences ile

Aydin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Numerical Pain Rating Scale

    Time frame: before the episiotomy intervention,

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

  2. Numerical Pain Rating Scale

    Time frame: during the hymen suturing during the episiotomy,

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

  3. Numerical Pain Rating Scale

    Time frame: one hour after the intervention.

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

  4. Postpartum Comfort Scale

    Time frame: after 24 hours

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

  5. Systolic Blood Pressure

    Time frame: before the episiotomy intervention,

    mmHg;

  6. diastolic Blood Pressure

    Time frame: before the episiotomy intervention,

    mmHg;

  7. Systolic Blood Pressure

    Time frame: during the hymen suturing during the episiotomy,

    mmHg;

  8. diastolic Blood Pressure

    Time frame: during the hymen suturing during the episiotomy, n

    mmHg;

  9. Systolic Blood Pressure

    Time frame: one hour after the intervention

    mmHg;

  10. diastolic Blood Pressure

    Time frame: one hour after the intervention

    mmHg;

  11. pulse,

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

    minute;

  12. espiratory rate

    Time frame: before the episiotomy intervention,

    unit

  13. espiratory rate

    Time frame: during the hymen suturing during the episiotomy,

    unit

  14. espiratory rate

    Time frame: one hour after the intervention

    unit

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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