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

Sponsor
Kırklareli University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05198908
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
9.6
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

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 and skin-to-skin contact application on pain and anxiety during episiotomy repair.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: VR group
  • Other: Skin to skin group
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled clinical trialRandomized controlled clinical trial
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Virtual Reality Glasse and Skin Contact Application on Pain and Anxiety During Episiotomy Repair: Double-blind Randomized-Controlled Study
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: VR group

VR (virtual reality glasse) group

Other: VR group
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.
Other Names:
  • VR (virtual reality glasse) group
  • Experimental: skin to skin group

    skin to contact group

    Other: Skin to skin group
    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.
    Other Names:
  • Skin to contact group
  • No Intervention: Control group-none

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Chance of pain felt during episiotomy repair [During study, an average of 1-1.5 hours]

      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).

    2. Chance of anxiety during episiotomy repair [Through study completion, an average of 1.5-2 hours]

      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.

    3. Introductory Information Form [Approximately 5-10 hours (after hospitalization).]

      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.

    4. Visual Analog Scale (VAS) [Approximately 1-1.5 hours (during and after episiotomy repair)]

      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.

    5. State-Trait Anxiety Inventory (STAI) [Approximately 1.5-2 hours (after episiotomy repair)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Kırklareli UniversityKırklareliTurkey

    Sponsors and Collaborators

    • Kırklareli University

    Investigators

    • Study Director: AYCA SOLT KIRCA, Phd, Kırklareli University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayca Solt Kirca, Assistant Professor, Kırklareli University
    ClinicalTrials.gov Identifier:
    NCT05198908
    Other Study ID Numbers:
    • KırklareliAS-5
    First Posted:
    Jan 20, 2022
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayca Solt Kirca, Assistant Professor, Kırklareli University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2022