Clinical trial NCT05198908: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Episiotomy Wound
Midwifery
Keywords: anxiety
pain
Episiotomy
Episiotomy wound
skin to contact
Midwifery
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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).

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).

Primary outcomes:
measure: Chance of pain felt during episiotomy repair
timeFrame: During study, an average of 1-1.5 hours
measure: Chance of anxiety during episiotomy repair
timeFrame: Through study completion, an average of 1.5-2 hours
measure: Introductory Information Form
timeFrame: Approximately 5-10 hours (after hospitalization).
measure: Visual Analog Scale (VAS)
timeFrame: Approximately 1-1.5 hours (during and after episiotomy repair)
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Approximately 1.5-2 hours (after episiotomy repair)
Secondary outcomes:
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli University
Study officials:
affiliation: Kırklareli University
name: AYCA SOLT KIRCA, Phd
role: STUDY_DIRECTOR
References: