AnxietyNCT00163917
A Study of the Effectiveness of Virtual Reality Relaxation Combined With Patient-Controlled Analgesia (PCA) Morphine for Those Undergoing Burn Dressing Changes
A study testing Virtual reality relaxation in people with Anxiety and Pain, run by Bayside Health at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate whether a sub-population of patients with burn injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes with improved pain and anxiety scores, when added to PCA morphine and background analgesic therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Virtual reality relaxation
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2004to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burn injury
- Scheduled for painful dressing changes
- Conscious
- Comprehension of PCA and virtual reality device
- Comprehension of the English language
Who cannot join
- Patient refusal
- Psychotic disease
- Paranoid disease
- Unstable dissociative disorder
- Borderline personality disorder
- Phobias relevant to water/drowning
Show all 13Show fewer
- Epilepsy/propensity to fitting
- Morphine allergy
- Acute brain syndrome
- Chronic brain syndrome
- Physically unable to administer PCA
- Severe burns involving the head
- Visual impairment
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3181
Alex Konstantatos, MBBS, 03 92763176 ext. 3757, a.konstantatos@alfred.org.au
Alex Konstantatos, MBBS
About this study
Official title: Predicting the Effectiveness of Virtual Reality Relaxation on Pain and Anxiety When Added to PCA Morphine in a Population of Burn Patients Having Dressing Changes
The purpose of this study is to evaluate whether a sub-population of patients with burn injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes with improved pain and anxiety scores, when added to PCA morphine and background analgesic therapy.
Read the detailed description
Pain associated with burn dressing changes does not arise purely from a physical source; it is also commonly influenced by psychological factors. The anticipation that accompanies a dressing change has the potential to set up fear and heightened anxiety as the patient is aware that at a predetermined time other people will manipulate injured areas on his/her body.
Many techniques of analgesia have been advocated in burn dressing changes. Opiates have been the mainstay, and many techniques for their administration have been described. In particular the use of background plus PCA administration of opiates has been demonstrated to be superior to PCA administration alone. Another analgesic/dissociative agent commonly described for these procedures is Ketamine. Both opiates and ketamine have limitations in that they cause unfavourable side effects such as respiratory depression, sedation and nausea and vomiting in the case of opiates and respiratory depression, hallucinations and unpleasant dreams in the case of ketamine. Other problems relating to the use of opiates and ketamine relate to the approach of treating a multifaceted experience such as burn dressing pain solely with pharmacotherapy.
The need for psychological interventions in burn dressings has been highlighted by many researchers. In particular, Ptacek noted that burn patients experiencing more anxiety tended to have higher ratings of pain, while those with larger areas of burns reported more affective pain and greater variability in pain ratings.
There is strong consistency among reviewers for recommending the addition of adjunctive therapies of a psychological nature for managing patients having burn dressing changes. Patterson et.al in particular is of the belief that burn patients having dressing changes are more amenable to hypnotherapy as an analgesic adjunct.
The nature of psychological interventions examined by researchers have included hypnosis (where strong suggestions were aimed at reducing tension, anxiety, and sensation of pain), rapid induction analgesia, simple stress reducing strategies, attention and information, and autohypnosis. While some have conducted prospective trials which involve large numbers of patients, only one trial actually made mention of randomizing participants. Most other reports examining psychological therapies have been at the case report level.
While most of these trials and case reports have reported favourable outcomes, no single trial has been able to consistently show a significant reduction of pain scores and anxiety ratings and analgesic consumption.
Virtual Reality (VR) assisted techniques that modify psychological well-being are beginning to play a role in clinical practise and in research. There are currently two publications, one a case report and another a prospective randomized trial which specifically examine the role of VR in the context of painful procedures associated with burn injuries. The randomized crossover trial by Hoffman et.al in 6 patients having physical therapy utilising immersive VR found a significant reduction in pain ratings in all patients, while Patterson et.al described the successful use of VR hypnosis in one "difficult" patient which had lasting effects for up to 48 hours.
Reviews of psychological therapies for patients having burn dressing changes have addressed the need for more systematic controlled trials to supplement existing evidence and more clearly define the role of such interventions. Coupled with this is the need for more knowledge as to the most appropriate psychological intervention and the ideal situations where it will prove most beneficial. Patterson feels that there is good anecdotal evidence that burn patients have a particular propensity to respond to adjunctive therapies incorporating hypnosis. Hypnosis screening among burn patients involving the hypnotic induction profile demonstrated a link between high hypnotizability and the experience of more intense arousal, greater avoidance and more significant feelings of intrusiveness.
We propose to conduct a prospective randomized trial which looks at the effect that VR relaxation has when combined with PCA morphine in a group of patients having potentially painful dressing changes. In addition we want to isolate patients who have high susceptability to hypnosis and compare their ratings of pain, anxiety and opiate requirement with patients of lesser susceptibility. Our hypothesis is that patients with higher susceptibility to hypnosis stand to gain most from the addition of VR to their pharmacotherapy.
- Being tested
- Virtual reality relaxation
- Keywords
- Hypnosis, Analgesia
- Medical subject headings
- Anxiety Disorders, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality relaxationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between hypnotic susceptibility and pain scores
Association between hypnotic susceptibility and anxiety scores
Secondary outcomes (6)
Measurement of pain by visual analogue scale (VAS)
Measurement of anxiety by Burns Specific Anxiety Rating by VAS
Rating of hypnotic susceptibility and morphine use
Satisfaction rating
Morphine use
Incidence of side effects relating to morphine and VR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Alex Konstantatos, MBBS, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163917
- Sponsor's protocol ID
- 107/ 04
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Effectiveness of Virtual Reality Relaxation on Pain and Anxiety When Added to PCA Morphine in a Population of Burn Patients Having Dressing Changes
- ClinicalTrials.gov ID
- NCT00163917
- Acronym / sponsor ID
- 107/ 04
- Keywords
- Hypnosis, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Bayside HealthOther government
- Study start
- Sep 2004
- First posted
- 14 Sep 2005 (estimated)
- 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.
The purpose of this study is to evaluate whether a sub-population of patients with burn injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes with improved pain and anxiety scores, when added to PCA morphine and background analgesic therapy.
Detailed description
Pain associated with burn dressing changes does not arise purely from a physical source; it is also commonly influenced by psychological factors. The anticipation that accompanies a dressing change has the potential to set up fear and heightened anxiety as the patient is aware that at a predetermined time other people will manipulate injured areas on his/her body.
Many techniques of analgesia have been advocated in burn dressing changes. Opiates have been the mainstay, and many techniques for their administration have been described. In particular the use of background plus PCA administration of opiates has been demonstrated to be superior to PCA administration alone. Another analgesic/dissociative agent commonly described for these procedures is Ketamine. Both opiates and ketamine have limitations in that they cause unfavourable side effects such as respiratory depression, sedation and nausea and vomiting in the case of opiates and respiratory depression, hallucinations and unpleasant dreams in the case of ketamine. Other problems relating to the use of opiates and ketamine relate to the approach of treating a multifaceted experience such as burn dressing pain solely with pharmacotherapy.
The need for psychological interventions in burn dressings has been highlighted by many researchers. In particular, Ptacek noted that burn patients experiencing more anxiety tended to have higher ratings of pain, while those with larger areas of burns reported more affective pain and greater variability in pain ratings.
There is strong consistency among reviewers for recommending the addition of adjunctive therapies of a psychological nature for managing patients having burn dressing changes. Patterson et.al in particular is of the belief that burn patients having dressing changes are more amenable to hypnotherapy as an analgesic adjunct.
The nature of psychological interventions examined by researchers have included hypnosis (where strong suggestions were aimed at reducing tension, anxiety, and sensation of pain), rapid induction analgesia, simple stress reducing strategies, attention and information, and autohypnosis. While some have conducted prospective trials which involve large numbers of patients, only one trial actually made mention of randomizing participants. Most other reports examining psychological therapies have been at the case report level.
While most of these trials and case reports have reported favourable outcomes, no single trial has been able to consistently show a significant reduction of pain scores and anxiety ratings and analgesic consumption.
Virtual Reality (VR) assisted techniques that modify psychological well-being are beginning to play a role in clinical practise and in research. There are currently two publications, one a case report and another a prospective randomized trial which specifically examine the role of VR in the context of painful procedures associated with burn injuries. The randomized crossover trial by Hoffman et.al in 6 patients having physical therapy utilising immersive VR found a significant reduction in pain ratings in all patients, while Patterson et.al described the successful use of VR hypnosis in one "difficult" patient which had lasting effects for up to 48 hours.
Reviews of psychological therapies for patients having burn dressing changes have addressed the need for more systematic controlled trials to supplement existing evidence and more clearly define the role of such interventions. Coupled with this is the need for more knowledge as to the most appropriate psychological intervention and the ideal situations where it will prove most beneficial. Patterson feels that there is good anecdotal evidence that burn patients have a particular propensity to respond to adjunctive therapies incorporating hypnosis. Hypnosis screening among burn patients involving the hypnotic induction profile demonstrated a link between high hypnotizability and the experience of more intense arousal, greater avoidance and more significant feelings of intrusiveness.
We propose to conduct a prospective randomized trial which looks at the effect that VR relaxation has when combined with PCA morphine in a group of patients having potentially painful dressing changes. In addition we want to isolate patients who have high susceptability to hypnosis and compare their ratings of pain, anxiety and opiate requirement with patients of lesser susceptibility. Our hypothesis is that patients with higher susceptibility to hypnosis stand to gain most from the addition of VR to their pharmacotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Burn injury
- Scheduled for painful dressing changes
- Conscious
- Comprehension of PCA and virtual reality device
- Comprehension of the English language
Key exclusion criteria (13 listed)
- Patient refusal
- Psychotic disease
- Paranoid disease
- Unstable dissociative disorder
- Borderline personality disorder
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 relaxation | Device | – |
Primary outcome
Association between hypnotic susceptibility and pain scores
Association between hypnotic susceptibility and anxiety scores
6 secondary outcomes
Measurement of pain by visual analogue scale (VAS)
Measurement of anxiety by Burns Specific Anxiety Rating by VAS
Rating of hypnotic susceptibility and morphine use
Satisfaction rating
Morphine use
Incidence of side effects relating to morphine and VR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2007.
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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.
Alex Konstantatos, MBBS principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality relaxation in people with Anxiety and Pain, run by Bayside Health at 1 site in Australia.
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 5 inclusion and 13 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 15 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Alex Konstantatos, MBBS, FANZCA (03 92763176 ext. 3757, a.konstantatos@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between hypnotic susceptibility and pain scores. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2007.