Effect of VR on Anxiety and Pain in Gynecological Surgery

NCT04687501 | Completed DMC

• 1 other identifier: NL72290.096.20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postoperative pain; Anxiety; State anxiety; Pain catastrophizing; Analgesic use

Outcome Measures

Primary Outcomes (1)

• NRS pain

  reduction in postoperative pain score (NRS, numeric rating scale). Scaling from 0-10, where 0 means no pain and 10 means the worst imaginable pain

  immediately after surgery

Secondary Outcomes (7)

• STAI (State-Trait Anxiety Inventory) questionnaire (6 questions)

  baseline

• Pain Catastrophizing Scale questionnaire

  baseline

• NRS anxiety

  baseline and immediately after surgery

• Analgesic use

  Within 24-48hours after surgery

• Length of hospital stay

  within 24-48hours after surgery

Study Arms (2)

VR-group

EXPERIMENTAL

The participants randomised into this group can choose for an immersive guided relaxation VR experience or an interactive VR experience. The VR intervention is additional to the standard postoperative care management, the standard pain protocol is explained below. The VR-intervention will be given using the Oculus Go Virtual Reality glasses with touchpad.

Device: Virtual Reality

Standard care-group

NO INTERVENTION

The participants randomized into the standard care- group will receive the usual standard pre-and postoperative management. Standard pain protocol: 1. Preoperative (arrival day-care unit) start with 1000mg paracetamol orally administered. 2. Postoperative Meloxicam 15mg orally administered, or when oral medication is not possible (due to nausea e.g.) than diclofenac supp 100mg or diclofenac i.v. 75mg. 3. On recovery ward, when necessary depending on pain score (NRS\>4): dipidolor 2.5-5mg i.v. and 10-15mg i.m. after consulting the anesthesiologist. 4. Postoperative at home 4dd1000mg paracetamol will be continued, in combination with meloxicam 1dd15mg during 3 days. Also tramadol 50mg with a maximum of 4dd will be prescribed.

Interventions

Virtual Reality DEVICE

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

VR-group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and orally given informed consent
• years and older
• Native Dutch speaker
• Indication for elective gynecological surgery under spinal anesthesia
• No contra-indication to anesthesia:

You may not qualify if:

• Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months' . The pain is not due to the gynecological problem.
• Chronical use of pain medication (opioids)
• History of prior opioid use defined as use within 8 to 90 days prior to the surgical procedure
• Alcohol or drug abuse
• Known car sickness
• Epileptic insults in previous history
• Psychotically seizures in previous history
• Claustrophobic
• Blindness
• History of mental illness

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Centre

Heerlen, 6419PC, Netherlands

Location

Related Publications (19)

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MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Martine Wassen, Dr

  Zuyderland Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: December 29, 2020
• Study Start: October 22, 2020
• Primary Completion: July 8, 2022
• Study Completion: July 9, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)