CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Virtual Realitydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04687501
NCT04687501N/ACompleted

The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery; a Randomised Controlled Trial

Zuyderland Medisch Centrum·interventional·Posted Dec 29, 2020·Updated Aug 16, 2022

In Brief

A clinical study evaluating Virtual Reality for Pain, Postoperative and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Rationale: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence virtual reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects. Objective: The aim of this study is to explore the effect of VR on pain in the immediate postoperative period after elective gynecological surgery. Secondary objectives are evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use. Study design: The study concerns a non-blinded, single centre, randomised controlled trial. Study population: Eligible women fulfill the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Centre location Heerlen. Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomised to the standard care- group will receive only the usual standard care pre-and postoperative. Main study parameters: The primary outcome is postoperative pain measured on a numeric rating scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in the study. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study population experiences a small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults. Participants of the study have to fill in a questionnaire before randomization and pre-and postoperative score of pain and anxiety on a zero to ten score scale.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 29, 2020
Enrollment StartOct 22, 2020
Primary CompletionJul 8, 2022
Study CompletionJul 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.5 years ago

Interventions

Virtual Realitydevice

Virtual reality in gynaecological surgery in the pre- and postoperative setting