Acute PainNCT04218396
Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis
A study testing Virtual Reality use during painful bedside procedure and Standard Treatment during painful bedside procedure in people with Acute Pain, run by University of Calgary.
Trial summary
Currently, most analgesic regimens for painful bedside procedures rely on pharmacologic sedation or high doses of opioids (e.g.: nurse-administered IV opioids, anxiolytics, and sedatives; patient-controlled analgesia; anesthesiologist-administered sedation; and occasionally general anesthesia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Virtual Reality use during painful bedside procedure and Standard Treatment during painful bedside procedure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2020to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing recurrent painful bedside procedures during hospitalization (at least 2 similar procedures during the course of hospital stay eg: wound dressing change)
- Anticipated duration of bedside procedure less than or equal to 2 hours
- Patients 18 years or older and able to provide informed consent
- Patients experiencing pain and/or anxiety from their bedside procedure (these patients are expected to benefit most from the analgesic/anxiolytic effects of VR).
- Patients who not wish to observe the painful bedside procedure (VR unit will provide sensory distraction and immersive experience, with HMD/goggles/headset, that allows patient not to witness procedure).
- Patients with adequate vision and hearing (with hearing aids if necessary) - patients with sensory limitations may not be able to benefit from the full effects of the VR sensory stimulation.
- Patients who are medically stable (should be free of acute conditions that could be dangerous when using VR)
Who cannot join
- Active seizure disorder, recent stroke (within 3 months), elevated intracranial pressure (visual and/or auditory stimulation may cause concerns with worsening acute central nervous system conditions)
- High risk for or active substance withdrawal; active substance intoxication (VR stimulation may worsen symptoms associated with substance intoxication and withdrawal)
- Active delirium (may preclude safe and effective use of VR as intended for anxiolysis and analgesia)
- Poor vision and hearing (precludes VR stimuli from being effective if the patient has sensory impairments that prevent them from seeing/hearing the VR effects)
- Open head/neck wound or head/neck injuries precluding safe use or wearing of the VR unit (headset, HMD, headphones)
- Body parasites, active eye infection, or other infectious diseases requiring contact isolation, droplet isolation, or airborne isolation (this exclusion limits the possibility of transmitting infectious diseases between patients with the use of the VR unit)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Efficacy and Feasibility of Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis: A Pilot Study
Currently, most analgesic regimens for painful bedside procedures rely on pharmacologic sedation or high doses of opioids (e.g.: nurse-administered IV opioids, anxiolytics, and sedatives; patient-controlled analgesia; anesthesiologist-administered sedation; and occasionally general anesthesia). Pharmacologic interventions are frequently associated with suboptimal analgesia, opioid-induced side effects, requirement for increased monitoring due to over sedation, and progressive acute tolerance to opioids over time, particularly with multiple/repeat procedures.
Alternative, non-pharmacologic strategies may help reduce pain, side-effects and opioid tolerance associated with painful bedside procedures. These strategies have not been studied as extensively, but are becoming more important in view of the current national opioid crisis. In particular, with recent technologic advancements, virtual reality (VR) has emerged as a non-pharmacologic modality for analgesia and anxiolysis, which can have tremendous benefits in acute pain management.
Read more
VR provides an immersive, realistic, often interactive experience for the user. It is frequently described as "transporting" the user to an alternate environment, with the use of high-fidelity head-mounted displays (HMD), noise-cancelling headsets, and a complete audio-visual experience. The user's sense of "presence" in the VR environment is crucial in providing patient engagement, and correlates with non-pharmacologic pain control.
VR has been shown to provide non-pharmacologic analgesia in children and adults undergoing painful procedures such as bedside wound care, burn treatment, and physical therapy. The use of VR during painful bedside procedures is one specific setting which offers a good starting point to investigate this technology for acute pain management.
Our study wishes to determine if VR plus standard therapy provides superior analgesia for painful bedside procedures (e.g. burn treatment, wound care) compared with standard therapy alone. Our primary outcome is a reduction in pain scores by 30%, as measured by a numerical analog scale (NAS) during painful bedside procedures. The investigators will use a randomized, cross-over study design in which hospitalized patients receiving repeated painful bedside procedures, will be randomized to 2 groups. Group A will have an initial painful bedside procedure under standard treatment only, and a repeat procedure under standard treatment + VR. Group B will have an initial procedure under standard treatment +VR, and a subsequent one under standard treatment. Questionnaires including pain scores and secondary outcomes will be administered to each patient before and after the bedside procedure. A convenience sample of patients will be recruited over 1 year (anticipated N~30).
- Conditions
- Acute Pain
- Being tested
- Virtual Reality use during painful bedside procedure, Standard Treatment during painful bedside procedure
- Keywords
- Acute Pain, Virtual Reality, Anxiolysis, Analgesia, Non-pharmacologic, Painful bedside procedure, Wound care, Dressing change
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality use during painful bedside procedureDevice
Virtual reality (VR) will be used in addition to standard analgesic practices during painful bedside procedures. A head mounted display (HMD, Oculus Go Model #1KWPH812PN8354) and noise-cancelling headphones (Sony Model #MDRZ110B) will be provided to the patient during the procedure. This unit involves the patient wearing VR goggles, noise-cancelling headphones, and using a smartphone-based program with various applications the patient can choose from for analgesia/relaxation (eg: calming imagery/scenery of nature, activities involving mindfulness, interactive games or guided imagery, music and imagery, exercise imagery...etc). There are numerous, standard applications available for the patient to choose from, and the choice of most optimal application for analgesia, distraction, or anxiolysis will be left to the decision of the patient prior to their procedure.
Standard Treatment during painful bedside procedureDrug
Pharmacologic sedation or high dose opioids (e.g. nurse-administered IV opioids, anxiolytics and sedatives, patient-controlled analgesia, anesthesiologist administered sedation, general anesthesia if required)
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment, Then Virtual Reality + Standard Treatment | Experimental | Participants will have an initial painful bedside procedure (eg: bedside wound care or dressing change) under standard treatment only. After a washout period, they then will have a repeat procedure (eg: similar bedside wound care or dressing change) under standard treatment AND virtual reality Receives: Device: Virtual Reality use during painful bedside procedure; Drug: Standard Treatment during painful bedside procedure |
| Virtual Reality + Standard Treatment, Then Standard Treatment | Experimental | Participants will have an initial painful bedside procedure (eg: bedside wound care or dressing change) under standard treatment AND virtual reality. After a washout period, they then will have a repeat procedure (eg: similar bedside wound care or dressing change) under standard treatment only. Receives: Device: Virtual Reality use during painful bedside procedure; Drug: Standard Treatment during painful bedside procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Analog Scale Pain Score
The primary outcome is a reduction in pain scores by 30%, as measured by a numerical analog scale (NAS) during painful bedside procedures. Minimum scale value 0, maximum 10, higher scores mean more pain, lower scores mean less pain.
Measured: During painful bedside procedure
Secondary outcomes (4)
Anxiety score - State Trait Anxiety Index short form questionnaire
Anxiety score during painful bedside procedure as measured by State Trait Anxiety Index short form questionnaire. There are 6 separate statements ("I feel calm", "I am tense", "I feel upset", "I am relaxed", "I feel content", "I am worried"), minimum score on each question is 1, maximum score is 4. Lower scores indicate not feeling the emotion/state, and higher scores indicate feeling that emotion/state strongly.
Measured: During painful bedside procedure
Quality of life measures - Quality of Recovery 15 questionnaire
Quality of Recovery 15 questionnaire - pain, nausea, psychometric data. Minimum score on first part of questionnaire (asking about positive features) is 0, maximum questionnaire score on first part of questionnaire is 100. On first part of questionnaire (asking about positive features), a lower score means a poorer outcome, a higher score means a better outcome. On the second part of the questionnaire, asking about negative experiences, the minimum score is 0, and the maximum score is 50. On the second part of the questionnaire (asking about negative features), a lower score means a better outcome, a higher score means a worse outcome.
Measured: During painful bedside procedure
Opioid use during painful bedside procedure
Measurement of opioid use/requirement during painful bedside procedure (in morphine equivalents)
Measured: During painful bedside procedure
Number of participants with side effects related to virtual reality use during painful beside procedure (Nausea, dizziness, and other patient-reported adverse events)
Nausea and other patient-reported adverse events side-effects and outcomes
Measured: During painful bedside procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start30 Jan 2020 (estimated)
- Primary completion20 Jan 2021 (estimated)
- Study completion20 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Hung, University of Calgary
- Investigators
- Linda Hung, MD, FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218396
- Sponsor's protocol ID
- REB19-1907
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2020
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
PubMed 29485536Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
PubMed 31308733Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.
PubMed 29025113
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Feasibility of Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis: A Pilot Study
- ClinicalTrials.gov ID
- NCT04218396
- Acronym / sponsor ID
- REB19-1907
- Conditions
- Acute Pain
- Keywords
- Acute Pain, Virtual Reality, Anxiolysis, Analgesia, Non-pharmacologic, Painful bedside procedure, Wound care, Dressing change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 30 Jan 2020 (estimated)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 20 Jan 2021 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, most analgesic regimens for painful bedside procedures rely on pharmacologic sedation or high doses of opioids (e.g.: nurse-administered IV opioids, anxiolytics, and sedatives; patient-controlled analgesia; anesthesiologist-administered sedation; and occasionally general anesthesia). Pharmacologic interventions are frequently associated with suboptimal analgesia, opioid-induced side effects, requirement for increased monitoring due to over sedation, and progressive acute tolerance to opioids over time, particularly with multiple/repeat procedures.
Alternative, non-pharmacologic strategies may help reduce pain, side-effects and opioid tolerance associated with painful bedside procedures. These strategies have not been studied as extensively, but are becoming more important in view of the current national opioid crisis. In particular, with recent technologic advancements, virtual reality (VR) has emerged as a non-pharmacologic modality for analgesia and anxiolysis, which can have tremendous benefits in acute pain management.
VR provides an immersive, realistic, often interactive experience for the user. It is frequently described as "transporting" the user to an alternate environment, with the use of high-fidelity head-mounted displays (HMD), noise-cancelling headsets, and a complete audio-visual experience. The user's sense of "presence" in the VR environment is crucial in providing patient engagement, and correlates with non-pharmacologic pain control.
VR has been shown to provide non-pharmacologic analgesia in children and adults undergoing painful procedures such as bedside wound care, burn treatment, and physical therapy. The use of VR during painful bedside procedures is one specific setting which offers a good starting point to investigate this technology for acute pain management.
Our study wishes to determine if VR plus standard therapy provides superior analgesia for painful bedside procedures (e.g. burn treatment, wound care) compared with standard therapy alone. Our primary outcome is a reduction in pain scores by 30%, as measured by a numerical analog scale (NAS) during painful bedside procedures. The investigators will use a randomized, cross-over study design in which hospitalized patients receiving repeated painful bedside procedures, will be randomized to 2 groups. Group A will have an initial painful bedside procedure under standard treatment only, and a repeat procedure under standard treatment + VR. Group B will have an initial procedure under standard treatment +VR, and a subsequent one under standard treatment. Questionnaires including pain scores and secondary outcomes will be administered to each patient before and after the bedside procedure. A convenience sample of patients will be recruited over 1 year (anticipated N~30).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment, Then Virtual Reality + Standard Treatment | Experimental | Device: Virtual Reality use during painful bedside procedure, Drug: Standard Treatment during painful bedside procedureParticipants will have an initial painful bedside procedure (eg: bedside wound care or dressing change) under standard treatment only. After a washout period, they then will have a repeat procedure (eg: similar bedside wound care or dressing change) under standard treatment AND virtual reality |
| Virtual Reality + Standard Treatment, Then Standard Treatment | Experimental | Device: Virtual Reality use during painful bedside procedure, Drug: Standard Treatment during painful bedside procedureParticipants will have an initial painful bedside procedure (eg: bedside wound care or dressing change) under standard treatment AND virtual reality. After a washout period, they then will have a repeat procedure (eg: similar bedside wound care or dressing change) under standard treatment only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing recurrent painful bedside procedures during hospitalization (at least 2 similar procedures during the course of hospital stay eg: wound dressing change)
- Anticipated duration of bedside procedure less than or equal to 2 hours
- Patients 18 years or older and able to provide informed consent
- Patients experiencing pain and/or anxiety from their bedside procedure (these patients are expected to benefit most from the analgesic/anxiolytic effects of VR).
- Patients who not wish to observe the painful bedside procedure (VR unit will provide sensory distraction and immersive experience, with HMD/goggles/headset, that allows patient not to witness procedure).
Key exclusion criteria (6 listed)
- Active seizure disorder, recent stroke (within 3 months), elevated intracranial pressure (visual and/or auditory stimulation may cause concerns with worsening acute central nervous system conditions)
- High risk for or active substance withdrawal; active substance intoxication (VR stimulation may worsen symptoms associated with substance intoxication and withdrawal)
- Active delirium (may preclude safe and effective use of VR as intended for anxiolysis and analgesia)
- Poor vision and hearing (precludes VR stimuli from being effective if the patient has sensory impairments that prevent them from seeing/hearing the VR effects)
- Open head/neck wound or head/neck injuries precluding safe use or wearing of the VR unit (headset, HMD, headphones)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality use during painful bedside procedureVirtual reality (VR) will be used in addition to standard analgesic practices during painful bedside procedures. A head mounted display (HMD, Oculus Go Model #1KWPH812PN8354) and noise-cancelling headphones (Sony Model #MDRZ110B) will be provided to the patient during the procedure. This unit involves the patient wearing VR goggles, noise-cancelling headphones, and using a smartphone-based program with various applications the patient can choose from for analgesia/relaxation (eg: calming imagery/scenery of nature, activities involving mindfulness, interactive games or guided imagery, music and imagery, exercise imagery...etc). There are numerous, standard applications available for the patient to choose from, and the choice of most optimal application for analgesia, distraction, or anxiolysis will be left to the decision of the patient prior to their procedure. | Device | Standard Treatment, Then Virtual Reality + Standard Treatment, Virtual Reality + Standard Treatment, Then Standard Treatment |
| Standard Treatment during painful bedside procedurePharmacologic sedation or high dose opioids (e.g. nurse-administered IV opioids, anxiolytics and sedatives, patient-controlled analgesia, anesthesiologist administered sedation, general anesthesia if required) | Drug | Standard Treatment, Then Virtual Reality + Standard Treatment, Virtual Reality + Standard Treatment, Then Standard Treatment |
Primary outcome
Numerical Analog Scale Pain Score
Time frame: During painful bedside procedure
The primary outcome is a reduction in pain scores by 30%, as measured by a numerical analog scale (NAS) during painful bedside procedures. Minimum scale value 0, maximum 10, higher scores mean more pain, lower scores mean less pain.
4 secondary outcomes
Anxiety score - State Trait Anxiety Index short form questionnaire
Time frame: During painful bedside procedure
Quality of life measures - Quality of Recovery 15 questionnaire
Time frame: During painful bedside procedure
Opioid use during painful bedside procedure
Time frame: During painful bedside procedure
Number of participants with side effects related to virtual reality use during painful beside procedure (Nausea, dizziness, and other patient-reported adverse events)
Time frame: During painful bedside procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Background: PubMed 29485536Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
- Background: PubMed 31308733Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
- Background: PubMed 29025113Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Hung, MD, FRCPC principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality use during painful bedside procedure and Standard Treatment during painful bedside procedure in people with Acute Pain, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Hung, MD, FRCPC (403-943-5554, linda.hung@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Analog Scale Pain Score (time frame: During painful bedside procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218396, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.