Effect of VR on Anxiety and Pain in Gynecological Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage, this is the definition of pain according to the International Association for the Study of Pain (IASP). Severe post-operative pain is experienced by approximately 50-80% of the patients. Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. Postoperative pain can cause a higher morbidity, because of cardiovascular, pulmonic and gastro-intestinal problems. Besides, surgery and acute pain are both independent risk factors for the development of chronic pain. The reduction of acute pain and therefore managing postoperative pain may contribute to the prevention of chronic pain. In general, nowadays, medication is the treatment of choice for acute pain and mainly opioid analgesics are used for pain relief. Worldwide this contributes to excessive drug dependence and opioid abuse. Opioid use comes with several negative side effects, for example a potential delay in recovery and an increased risk of permanent disability. Nowadays, new methods related to pain management are developed. For example, Virtual reality (VR) is an upcoming technology used within healthcare. It is thought that the perception of pain is related to the amount of attention that is given to pain stimuli. The theory behind the working mechanism of VR to reduce pain is that VR acts as a distraction to limit the user's processing of nociceptive stimuli, by stimulating the visual cortex in the brain. In 2000, Hoffman published the first preliminary evidence for the beneficial effect of VR in reducing pain in a burn care unit. They also showed a trend to experience less anxiety during VR use. In the next upcoming years, a growing body of research was done to explore the effects of VR. A recent systematic review and meta-analysis showed VR to be an effective treatment for reducing acute pain. Next to being effective in reducing pain, it is also a proven useful tool in reducing preoperative anxiety. VR can be used as a safe, non-invasive, analgesic method, without risks of drug addiction and minimum side effects. In this study, the investigators want to explore the effect of VR on postoperative pain in patients undergoing elective gynecological surgery as a serious alternative for pain medication. The investigators hypothesize VR will reduce post-operative pain and consequently postoperative opioid use and anxiety reduction.

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

Conditions
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Pain, Postoperative, Anxiety, Pain Catastrophizing, State Anxiety

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written and orally given informed consent 18 years and older Native Dutch speaker Indication for elective gynecological surgery under spinal anesthesia No contra-indication to anesthesia: Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-group<br>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<br>* Virtual reality in gynaecological surgery in the pre- and postoperative setting<br>|
| No Intervention: Standard care-group<br>The participants randomized into the standard care- group will receive the usual standard pre-and postoperative management. Standard pain protocol: Preoperative (arrival day-care unit) start with 1000mg paracetamol orally administered. 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. 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. 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI (State-Trait Anxiety Inventory) questionnaire (6 questions) | Pre-operative anxiety. The score ranges from 20 to 90 and the higher the score the more anxiety the person experiences | baseline | 
| Pain Catastrophizing Scale questionnaire | Pain catastrophizing. The subscales of the PCS can be calculated separately or overall with a maximum total score of 52. The higher the score, the more catastrophizing thoughts are present. | baseline | 
| NRS anxiety | Difference in anxiety scores pre-and post VR intervention. Scaling on a scale form 0 to 10, where 0 means no anxiety and 10 means the worst imaginable anxiety | baseline and immediately after surgery | 
| Analgesic use | daily use of paracetamol, NSAIDs, opioids | Within 24-48hours after surgery | 
| Length of hospital stay | Length of hospital stay | within 24-48hours after surgery | 
| VR Questionnaire | Tolerability, feasibility and satisfaction of VR use | within 24hours after surgery | 
| NRS pain preoperative | Preoperative pain score (NRS). Scaling from 0-10, where 0 means no pain and 10 means the worst imaginable pain | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Anxiety, State anxiety, Pain catastrophizing, Analgesic use