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OpenTrials
Completed

NCT Number: NCT06534086

Virtual Reality for Urological Procedures

It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. However, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. Stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries.

The current study will examine the feasibility and pilot outcomes of Virtual Reality (VR) guided meditation therapy during cystoscopies and vasectomies. Feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the VR intervention during the procedures. The investigators will also evaluate pilot outcomes of the VR intervention on pain, anxiety, and overall satisfaction with the procedure. Results of this study will inform the development of a large-scale randomized clinical trial (RCT) to evaluate the efficacy of this intervention.

Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.

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Key information

Conditions

Feasibility Anxiety Disorders Anxiety State Behavior Health Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Satisfaction, Patient Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Men's Health Clinic

Winnipeg, Manitoba, R3P 2S8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • can speak and read English
  • have an indication for a cystoscopy or elected for a vasectomy
  • are scheduled to undergo their respective procedure under local anesthesia at the Men's Health Clinic between the dates of May-November 2024.

Exclusion criteria

  • those who are not competent to provide informed consent (e.g., due to cognitive impairment)
  • those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)

Treatment and study plan

Virtual reality (VR) guided meditation therapy

Device

Tripp application on Meta Quest 3 VR headset

Treatment as Usual

Other

No VR, local anesthetic only

Primary outcomes

  1. Recruitment rate

    Time frame: through study completion, up to 1 year

    Proportion of individuals who consent to participation and the number of recruited participants per week

  2. Inclusion criteria and demographic and surgery-related differences

    Time frame: through study completion, up to 1 year

    Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants

  3. Retention of participants in the study

    Time frame: Immediate post-operative

    Proportion of individuals who tolerate the intervention and complete the study

  4. Acceptability through elevate scores on the Virtual Reality Impression Scale

    Time frame: Immediate post-operative

    Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)

  5. Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale

    Time frame: Immediate post-operative

    Negative and positive impressions of the VR intervention (open ended/qualitative)

Secondary outcomes

  1. Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)

    Time frame: Pre-operative, acute post-operative (immediately following surgery)

    Brief self-report visual analogue scales (VAS) for anxiety/distress (0 thru 10, 10=worse anxiety/distress)

  2. Visual Analogue Scale pain severity

    Time frame: Peri-operative (mid-way through procedure)

    Brief self-report visual analogue scales (VAS) for acute pain (o thru 10, 10=more severe pain)

  3. Visual Analogue Scale anxiety severity

    Time frame: Peri-operative (mid-way through procedure)

    Brief self-report visual analogue scales (VAS) for acute anxiety (0 thru 10, 10=more severe anxiety)

  4. State Trait Anxiety Inventory (STAI) elevated scores

    Time frame: Pre-operative, acute post-operative (immediately following surgery)

    Brief self-report questionnaire with questions surrounding anxiety traits (0 thru 63, higher score=more severe anxiety)

  5. PROMIS Pain Intensity Scale total score

    Time frame: Acute post-operative (immediately following surgery)

    Brief self-report questionnaire with questions surrounding experienced pain (3 thru 15, 15=greater pain severity)

  6. i-Group Presence Questionnaire (IPQ) score

    Time frame: Acute post-operative (immediately following surgery)

    Brief self-report questionnaire with questions surrounding VR experience (spatial presence, involvement, experience realism), higher scores=greater presence

  7. Satisfaction With Surgery score

    Time frame: Acute post-operative (immediately following surgery)

    Item to assess overall satisfaction with surgery (0 thru 10, 10=greater satisfaction)

  8. Selection of VR experience

    Time frame: Pre-operative

    What Tripp experience that participants select (out of 5 potential programs)

  9. Subjective assessment of time spent in VR vs. actual time in VR

    Time frame: Evaluated immediate post-operative

    Perception of time during procedure compared to actual time among those in VR

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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