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

NCT05198908 | Completed

• 1 other identifier: KırklareliAS-5
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Episiotomy Wound; Midwifery

Keywords

anxiety; pain; Episiotomy; Episiotomy wound; skin to contact; Midwifery

Outcome Measures

Primary Outcomes (5)

• 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).

  During study, an average of 1-1.5 hours

• 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.

  Through study completion, an average of 1.5-2 hours

• 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.

  Approximately 5-10 hours (after hospitalization).

• 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.

  Approximately 1-1.5 hours (during and after episiotomy repair)

• 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.

  Approximately 1.5-2 hours (after episiotomy repair)

Study Arms (3)

VR group

EXPERIMENTAL

VR (virtual reality glasse) group

Other: VR group

skin to skin group

EXPERIMENTAL

skin to contact group

Other: Skin to skin group

Control group-none

NO INTERVENTION

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.

Interventions

VR group OTHER

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.

Also known as: VR (virtual reality glasse) group

VR group

Skin to skin group OTHER

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.

Also known as: Skin to contact group

skin to skin group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old,
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

Kırklareli University

Kırklareli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• AYCA SOLT KIRCA, Phd

  Kırklareli University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: January 20, 2022
• Study Start: February 15, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)