Clinical Trials Logo
  1. Home
  2. Anxiety
  3. NCT04693013
  4. Details
NCT04693013 Clinical Trial

Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy

Anxiety Clinical Trial

Official title:
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04693013
Other study ID # 0103-20-ZIV
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date April 30, 2024

Study information
Verified date July 2023
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations

Description:

Perineal lacerations and episiotomies are common after vaginal birth. Surgical repair of these conditions can cause discomfort and anxiety for the post-partum woman. The purpose of this research is to determine if the use of virtual reality (VR) during repair of a perineal laceration or episiotomy can decrease the anxiety level of the woman. Other parameters that will be measured will be vital signs, time of procedure, and pain level. 84 eligible healthy women after spontaneous or instrumental vaginal birth will be enrolled. Allocation will be randomized by previous sealed envelopes. 42 in the VR group and 42 in the control group. The 42 women in the VR group will have the device placed band in use before the onset of the procedure. Anxiety level will be measured post-procedure by (STAI) State Inventory Anxiety Trait. Pain will be measure by VAS. Assuming a significant anxiety level of 60% in women undergoing repair of a perineal laceration of episiotomy, in order to demonstrate a reduction to 30% in women using VR with a power of 80% and alpha of 0.05, 42 women will be needed in each group.

Recruitment information / eligibility
Status Recruiting
Enrollment 84
Est. completion date April 30, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Post-partum vaginal delivery, spontaneous or instrumental - Episiotomy or 1st or 2nd degree perineal tear - informed consent Exclusion Criteria: - Cesarean delivery - 3rd or 4th degree perineal tear - no informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Virtual Reality for Anxiety Reduction
Virtual Reality for Anxiety Reduction during suturing of perineum

Locations
Country Name City State
Israel David Peleg Safed

Sponsors (1)
Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety Level questionairre Immediately after procedure
Secondary Pain Level questionairre Immediately after procedure
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Completed NCT06421233 - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels N/A