Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

The goal of this study is to assess the feasibility of an expanded virtual reality (VR) intervention designed to help prepare patients for cancer surgery. This study will: (1) assess the investigator's ability to recruit, retain, and engage participants, (2) evaluate how acceptable participants find the intervention through their feedback on its individual components. The investigators will also explore whether baseline anxiety levels or psychiatric history predict responses to the intervention, as well as look for any changes in perioperative anxiety and monitoring for any adverse effects associated with the intervention. This study will also investigate engagement of providing participants with a first-person VR session recordings to determine utility and whether post-session access is perceived as beneficial. Finally, preliminary pilot outcomes will examine whether increased engagement in the VR results in reductions in anxiety on the day of surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality

    Device

    The VR simulation involves the experience of prepping, waiting, receiving, and recovering from surgery at a large tertiary care centre in Central Canada. It is designed to prepare patients for cancer surgery by increasing familiarity with the hospital environment, providing the opportunity to "experience" restricted areas of the hospital that patients cannot access until the day of the surgery, and better understand the surgical process. The simulation was originally developed for a prior research project focused on breast cancer surgery and has since been adapted based on participant feedback. The intervention includes multiple modules that progress from an orientation to the hospital environment to more immersive, first-person surgical experiences.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Daily Viewing GroupOther 1 intervention
Group B: Self-directed groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Engagement

Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session

Time frame
Day 0 post-intervention
2

Acceptability

The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.

Time frame
Day 0 post-intervention

Secondary outcomes

1

Anxiety

Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.

Time frame
Baseline
2

Depression

Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms.

Time frame
Baseline
3

Pre-Operative Anxiety

Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items.

Time frame
Baseline and re-administered pre-operatively on the day of surgery
4

Pre-Operative Anxiety

Pre-operative Intrusive Thoughts Inventory (PITI). Range 0 to 60 on 20 items, score \>15 indicative of clinically significant preoperative anxiety.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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