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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

Tracking Information
First Submitted Date  ICMJE September 14, 2021
First Posted Date  ICMJE November 24, 2021
Last Update Posted Date November 24, 2021
Actual Study Start Date  ICMJE November 1, 2020
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2021)
  • 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).
  • 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).
  • 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).
  • 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.
  • Systolic Blood Pressure [ Time Frame: before the episiotomy intervention, ]
    mmHg;
  • diastolic Blood Pressure [ Time Frame: before the episiotomy intervention, ]
    mmHg;
  • Systolic Blood Pressure [ Time Frame: during the hymen suturing during the episiotomy, ]
    mmHg;
  • diastolic Blood Pressure [ Time Frame: during the hymen suturing during the episiotomy, n ]
    mmHg;
  • Systolic Blood Pressure [ Time Frame: one hour after the intervention ]
    mmHg;
  • diastolic Blood Pressure [ Time Frame: one hour after the intervention ]
    mmHg;
  • pulse, [ Time Frame: before the episiotomy intervention, during the hymen suturing during the episiotomy, and one hour after the intervention ]
    minute;
  • espiratory rate [ Time Frame: before the episiotomy intervention, ]
    unit
  • espiratory rate [ Time Frame: during the hymen suturing during the episiotomy, ]
    unit
  • espiratory rate [ Time Frame: one hour after the intervention ]
    unit
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Perceived by Women During Episiotomy Repair
Official Title  ICMJE The Effect of Virtual Reality Glasses Watched With Music on Pain Perceived by Women During Episiotomy Repair, Vital Signs and Postpartum Comfort
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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Virtual Reality
  • Birth
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: During Episiotomy Repair, Women Will Be Watching Virtual Reality Glasses Accompanied by Music
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2021)
84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: primipary
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05134376
Other Study ID Numbers  ICMJE AYDIN ADNAN MENDERES UNUVERSTY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mine Gokduman Keles, Aydin Adnan Menderes University
Study Sponsor  ICMJE Aydin Adnan Menderes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: mine gökduman keleş, 1
PRS Account Aydin Adnan Menderes University
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP