RecruitingACTRN12622000216718

Virtual Reality Analgesia for Post Laparoscopic Pain

An open label randomised controlled trial to investigate the effect of virtual reality on post laparoscopy pain.

Sponsor

Monash University Department of Obstetrics and Gynaecology

Enrollment

142 participants

Start Date

Feb 28, 2022

Study Type

Interventional

Conditions

Post-laparoscopic gynaecological surgery Pain

Summary

Laparoscopy is a commonly performed gynaecological procedure. Studies evaluating post-laparoscopic gynaecological surgery pain suggest post-operative pain is experienced by 35–65% of women. One study demonstrated that ~46% of patients post-laparoscopy were in severe pain and required significantly greater amounts of analgesia than patients undergoing laparotomy. Virtual reality (VR) is a technological medium that is used to create simulated scenarios in which users are immersed and able to interact with through stimulation of the senses. In recent years, there has been a growing interest in medicine for its potential to provide pain relief with positive results being reported. The mechanism responsible for this phenomenon is not yet fully understood, but is attributed to its ability to distract users from perceiving pain and also due to neurophysiological changes that result from long-term use. Given the potential of VR to facilitate analgesia, this study hypothesises that VR technology can reduce pain and analgesic requirements with minimal side effects to provide a solution to the existing clinical gap.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria5

The women in the following group:
Undergoing laparoscopy for any indication
The following criteria are relevant as:
All indication for gynaecological laparoscopy were considered suitable for pain assessment
Sufficient English language comprehension

Exclusion Criteria8

Conversion to laparotomy
Chronic narcotic use / dependence
Pregnancy
Prior history of sensitivity to VR technology, motion sickness, vertigo, seizures, epilepsy and active nausea and vomiting
Women below 18 years of age
Patients with an intellectual impairment
People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process
People highly dependent on medical care

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Interventions

We will be using virtual reality (VR) technology as our intervention (and adjunct to routine care). This technology is a non-invasive distraction that is achieved through the application of a head-mounted device, that can easily be removed at any time. VR allows for users to be immersed in a three-dimensional virtual environment through multisensorial stimulation. For this study, commercially available virtual reality headsets containing custom-designed content will be provided to individuals of the intervention group for a duration of 10 minutes. To ensure adherence to the virtual reality headset, the trials will be performed under direct observation by a member of the research team and participants will be required to complete a post-procedure questionnaire. The content that will be displayed on the virtual reality headset is called "Meridian". In Meridian, the semi-recumbent user is situated in a space environment and will focus their gaze to point a handheld crystal staff towards a high tempo and steady progression of incoming rings which stream towards the user in a diverse range of patterns. This experience takes place against a backdrop of classical music and requires minimal movement from the patient. VR administration is for one session only, whilst the patient is in recovery.