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Effect of VR on Anxiety and Pain in Gynecological Surgery

NCT04687501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-16

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Anxiety
  • Pain Catastrophizing
  • State Anxiety

Interventions

DEVICE

Virtual Reality

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

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • Martine Wassen, Dr · Zuyderland Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2022-07-08
Completion
2022-07-09

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04687501 on ClinicalTrials.gov