Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Perceived by Women During Episiotomy Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05134376
Recruitment Status : Completed
First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Mine Gokduman Keles, Aydin Adnan Menderes University

Brief 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. 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


Condition or disease Intervention/treatment Phase
Virtual Reality Birth Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This research is a randomized controlled experimental study.
Masking: None (Open Label)
Masking Description: episiotomy application and intervention was done by midwives
Primary Purpose: Supportive Care
Official Title: The Effect of Virtual Reality Glasses Watched With Music on Pain Perceived by Women During Episiotomy Repair, Vital Signs and Postpartum Comfort
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021

Arm Intervention/treatment
Experimental: Workgroup
During 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.
Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music
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.

No Intervention: Control
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 done in the same way.



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   primipary
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05134376


Locations
Layout table for location information
Turkey
Adnan Menderes University Institute of Health Sciences ile
Aydın, Turkey
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
Layout table for investigator information
Study Director: mine gökduman keleş, 1
Layout table for additonal information
Responsible Party: Mine Gokduman Keles, Head of Otolaryngology, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT05134376    
Other Study ID Numbers: AYDIN ADNAN MENDERES UNUVERSTY
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mine Gokduman Keles, Aydin Adnan Menderes University:
Virtual Reality
labor
pain
episiotomy