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The Effect of Virtual Reality Glasse on Pain and Anxiety During Episiotomy Repair

Primary Purpose

Anxiety, Pain, Episiotomy Wound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
VR group
Skin to skin group
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring anxiety, pain, Episiotomy, Episiotomy wound, skin to contact, Midwifery

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 20-40 years old,
  • 37-42. to be in the week of pregnancy,
  • Singular pregnancy, being primiparous,
  • Mediolateral episiotomy,
  • Having a planned vaginal birth,
  • Having a vertex presentation,
  • Newborn APGAR score of 7 and above,
  • Newborn weighing between 2-4 kg,
  • Signing the voluntary consent form, who has not used a non-pharmacological method before

Exclusion Criteria:

  • Obstetric or non-obstetric complications
  • Any obstetric complication or bleeding that requires urgent action,
  • Using sedative drugs before and during episiotomy repair (except lidocaine applied in hospital routine),
  • A condition that does not require episiotomy repair (small amounts of separation, etc.),
  • Lacerations other than episiotomy (anal sphincter injury, 3rd or 4th degree laceration), episiotomies below 2 cm and above 4 cm,
  • Instrument delivery (vacuum or forceps),
  • Postpartum complications in the newborn,
  • Chronic disease (Diabetes Mellus, thyroid, Hypertension),
  • Regular drug use
  • Having any problems that prevent communication (such as not knowing Turkish, hearing, speaking and understanding problems),
  • Psychiatric treatment (Pharmacotherapy or psychotherapy).

Sites / Locations

  • Kırklareli University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

VR group

skin to skin group

Control group-none

Arm Description

VR (virtual reality glasse) group

skin to contact group

Women in this group will not be subjected to any treatment other than the routine hospital protocol. Before episiotomy repair, each woman is given superficial perineal anesthesia with a 4 ml ampoule of Jetocaine (ADEKA®, lidocaine HCl 40 mg/2 mL, epinephrine 0.025 mg/2 mL). This dose is repeated if necessary.

Outcomes

Primary Outcome Measures

Chance of pain felt during episiotomy repair
The participants who met the inclusion criteria will included in the study. In practice, VAS will be administered separately to the women in the experimental groups and control group (pre-procedure, skin repair, immediately after skin repair, in the first hour after skin repair).
Chance of anxiety during episiotomy repair
The participants who met the inclusion criteria will included in the study.Participants in the experimental groups and control group will be followed for 1 hour in the delivery room after the episiotomy repair is completed.At the end of the follow-up, women who will be taken to the service will have the STAI scale filled.
Introductory Information Form
This form, developed by the researchers in line with the literature, consists of 20 questions in total, including information about sociodemographic characteristics, medical and obstetric pregnancy history, and current pregnancy of the woman.
Visual Analog Scale (VAS)
The scale was first developed and used by Bond and Pilowsky in 1966. The VAS is a 10 cm scale that expresses "painless" at one end and "worst pain" at the other. in VAS; 0 cm means "no pain", 0.5 cm - 3.0 cm means "mild pain", 3.5 cm - 6.5 cm means "moderate pain" and 7.0 cm - 10.0 cm means "severe pain". income.
State-Trait Anxiety Inventory (STAI)
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=none, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score, the higher the level of anxiety. The alpha value of the scale is 0.86-.92.33. Necessary permissions were obtained for the use of the scale.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2021
Last Updated
November 15, 2022
Sponsor
Kırklareli University
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1. Study Identification

Unique Protocol Identification Number
NCT05198908
Brief Title
The Effect of Virtual Reality Glasse on Pain and Anxiety During Episiotomy Repair
Official Title
The Effect of Virtual Reality Glasse on Pain and Anxiety During Episiotomy Repair: Double-blind Randomized-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Episiotomy is one of the common surgical operations that can cause anxiety in women and have side effects such as pain. Nerve blockades with analgesic effects such as lidocaine used during episiotomy repair or the use of tranquilizers and sleep-inducing drugs used to reduce anxiety during this procedure may have side effects. Nowadays, the trends towards non-medical methods (virtual reality glasses, praying, distraction, music therapy) in addition to medical methods during episiotomy repair are increasing due to the inevitable nature of these methods and the absence of side effects. In the study, it is stated that women will prefer non-medical methods (such as distraction or prayer) to alleviate pain or anxiety. It is important for midwives to have knowledge about these alternative methods (music therapy, virtual reality glasses, distraction, massage, acupressure, praying) to reduce the pain and anxiety that occurs during episiotomy repair. A new technology, virtual reality (VR), helps users connect to an environment that simulates reality, reducing pain by distracting them from the real world through computers or other devices. Although initially considered a technology only for the entertainment industry, its field of application has grown over the past decade to include various clinical areas such as pain management, physical rehabilitation, and psychiatric disorders. VR is suitable for clinical use and is a non-invasive and drug-free analgesic method. Its use in obstetrics is very new. Virtual reality glasses are recognized as a safe, inexpensive and effective non-pharmacological anxiolytic agent that allows for the reduction of regular pharmacological sedative doses due to their effect on anxiety and pain perception. Skin-to-skin contact is defined by the World Health Organization as the basic component of postnatal care. Skin-to-skin contact helps to reduce the pain felt during episiotomy repair in the mother and in the postpartum period. This research was planned to determine the effect of virtual reality glasses on pain and anxiety during episiotomy repair.
Detailed Description
Episiotomy is one of the common surgical operations that can cause anxiety in women and have side effects such as pain. Nerve blockades with analgesic effect such as lidocoin used during episiomy repair or the use of tranquilizers and sleep-inducing drugs used to reduce anxiety during this procedure may have side effects.This research was planned to determine the effect of virtual reality glasses and skin-to-skin contact application on pain and anxiety during episiotomy repair.This study is A prospective, double-blinded randomized controlled trial. Participants will randomized into VR, skin to contact, and control groups.Participants will be consisted of women over 20 years of age, 37-42. to be in the week of pregnancy, Singular pregnancy, being primiparous, Mediolateral episiotomy, Having a planned vaginal birth, Having a vertex presentation, Newborn APGAR score of 7 and above, Newborn weighing between 2-4 kg. In the selection of participants who meet the research criteria for the study, an introductory information form created by the researchers in the light of the literature will be used. Later, each method (VR,skin to contact and control group) will be evaluated for Visual Analog scale (VAS), State-Trait Anxiety Inventory (STAI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Episiotomy Wound, Midwifery
Keywords
anxiety, pain, Episiotomy, Episiotomy wound, skin to contact, Midwifery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR group
Arm Type
Experimental
Arm Description
VR (virtual reality glasse) group
Arm Title
skin to skin group
Arm Type
Experimental
Arm Description
skin to contact group
Arm Title
Control group-none
Arm Type
No Intervention
Arm Description
Women in this group will not be subjected to any treatment other than the routine hospital protocol. Before episiotomy repair, each woman is given superficial perineal anesthesia with a 4 ml ampoule of Jetocaine (ADEKA®, lidocaine HCl 40 mg/2 mL, epinephrine 0.025 mg/2 mL). This dose is repeated if necessary.
Intervention Type
Other
Intervention Name(s)
VR group
Other Intervention Name(s)
VR (virtual reality glasse) group
Intervention Description
Women in this group will wear virtual reality glasses (15-20 minutes) until the episiotomy repair begins and ends. At the same time, the hospital protocol will be applied to this group. Before episiotomy repair, each woman is given superficial perineal anesthesia with a 4 ml ampoule of Jetocaine (ADEKA®, lidocaine HCl 40 mg/2 mL, epinephrine 0.025 mg/2 mL). This dose is repeated if necessary.
Intervention Type
Other
Intervention Name(s)
Skin to skin group
Other Intervention Name(s)
Skin to contact group
Intervention Description
For women in this group, a warm sterile operating room towel will be placed on the newborn until the episiotomy repair begins and ends, so that her naked body remains on the mother's chest.At the same time, the hospital protocol will be applied to this group. Before episiotomy repair, each woman is given superficial perineal anesthesia with a 4 ml ampoule of Jetocaine (ADEKA®, lidocaine HCl 40 mg/2 mL, epinephrine 0.025 mg/2 mL). This dose is repeated if necessary.
Primary Outcome Measure Information:
Title
Chance of pain felt during episiotomy repair
Description
The participants who met the inclusion criteria will included in the study. In practice, VAS will be administered separately to the women in the experimental groups and control group (pre-procedure, skin repair, immediately after skin repair, in the first hour after skin repair).
Time Frame
During study, an average of 1-1.5 hours
Title
Chance of anxiety during episiotomy repair
Description
The participants who met the inclusion criteria will included in the study.Participants in the experimental groups and control group will be followed for 1 hour in the delivery room after the episiotomy repair is completed.At the end of the follow-up, women who will be taken to the service will have the STAI scale filled.
Time Frame
Through study completion, an average of 1.5-2 hours
Title
Introductory Information Form
Description
This form, developed by the researchers in line with the literature, consists of 20 questions in total, including information about sociodemographic characteristics, medical and obstetric pregnancy history, and current pregnancy of the woman.
Time Frame
Approximately 5-10 hours (after hospitalization).
Title
Visual Analog Scale (VAS)
Description
The scale was first developed and used by Bond and Pilowsky in 1966. The VAS is a 10 cm scale that expresses "painless" at one end and "worst pain" at the other. in VAS; 0 cm means "no pain", 0.5 cm - 3.0 cm means "mild pain", 3.5 cm - 6.5 cm means "moderate pain" and 7.0 cm - 10.0 cm means "severe pain". income.
Time Frame
Approximately 1-1.5 hours (during and after episiotomy repair)
Title
State-Trait Anxiety Inventory (STAI)
Description
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=none, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score, the higher the level of anxiety. The alpha value of the scale is 0.86-.92.33. Necessary permissions were obtained for the use of the scale.
Time Frame
Approximately 1.5-2 hours (after episiotomy repair)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-40 years old, 37-42. to be in the week of pregnancy, Singular pregnancy, being primiparous, Mediolateral episiotomy, Having a planned vaginal birth, Having a vertex presentation, Newborn APGAR score of 7 and above, Newborn weighing between 2-4 kg, Signing the voluntary consent form, who has not used a non-pharmacological method before Exclusion Criteria: Obstetric or non-obstetric complications Any obstetric complication or bleeding that requires urgent action, Using sedative drugs before and during episiotomy repair (except lidocaine applied in hospital routine), A condition that does not require episiotomy repair (small amounts of separation, etc.), Lacerations other than episiotomy (anal sphincter injury, 3rd or 4th degree laceration), episiotomies below 2 cm and above 4 cm, Instrument delivery (vacuum or forceps), Postpartum complications in the newborn, Chronic disease (Diabetes Mellus, thyroid, Hypertension), Regular drug use Having any problems that prevent communication (such as not knowing Turkish, hearing, speaking and understanding problems), Psychiatric treatment (Pharmacotherapy or psychotherapy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYCA SOLT KIRCA, Phd
Organizational Affiliation
Kırklareli University
Official's Role
Study Director
Facility Information:
Facility Name
Kırklareli University
City
Kırklareli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Virtual Reality Glasse on Pain and Anxiety During Episiotomy Repair

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