BurnsNCT01828541
Hypnosis for Pain and Itch Following Burn Injuries
A study testing Hypnosis in people with Burns, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. Primary hypothesis: Hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Ability to provide informed consent for study participation
- ability to read and understand English
- Undergoing pharmacologic therapy for burn related itch according to the standard itch protocol
- Scoring of 4 out of 10 on the Numerical Rating Scale for average itch or pain
Who cannot join
- Age less than 18 or greater than 65
- Inability to provide informed consent
- Inability to read or understand English
- Delirium
- History of mania, paranoia, dissociation and current suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries
The purpose of this study is to determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. Primary hypothesis: Hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year post-burn injury.
Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and fewer symptoms of Post Traumatic Stress Disorder (PTSD).
Read more
Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the gabapentin doses and have lower average pain scores than those in the control group.
Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early after injury will report lower rates of neuropathic pain and itch than subjects who will be enrolled in the study and receive hypnosis later in the healing process.
Read the detailed description
This is a randomized, controlled study comparing two groups of subjects, those in the control (standard care) group and those in the experimental group (hypnosis).
Control subjects will receive treatment as usual, which consists of a standardized protocol for treating post-burn itch. This protocol is based on past research and combines medications in a stepped approach that establishes therapeutic decisions based on clearly defined criteria.
Subjects randomized to the experimental group will undergo four sessions of live hypnosis completed over a two month period. They will be provided with a Compact Disk (CD) of each session and instructed to listen to it daily. Post-hypnotic suggestions will address uncomfortable sensations, with additional suggestions for improved sleep and well-being. Subjects may be inpatient or outpatients.
- Conditions
- Burns
- Being tested
- Hypnosis, Standard of Care
- Keywords
- Burn injuries
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Patients in this group will receive standard care plus 4 sessions of hypnosis.
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | Subjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications. Receives: Other: Standard of Care |
| Hypnosis Condition | Experimental | Subjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period. Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical Rating Scale for Average Itch
Subjects will be asked to rate their average itch intensity over the previous 24-hour period using the 0 (no itch) to 10 (worst itch imaginable) scale. Change in this measures over time will be assessed.
Measured: 48 hours, 1-, 3-, 6-, 12- months post-randomization
Secondary outcomes (5)
Change in Numerical Rating Scale for Pain
Subjects will be asked to rate their average pain intensity over the past 24 hours using the 0(no pain) to 10 (worst pain imaginable) scale. Change in this measure over time will be assessed.
Measured: 48 hours, 1-. 3-. 6-, 12-months post-randomization
Change in Medical Outcomes Study of Sleep
This tool measures six different sleep constructs. We will use the 9-item sleep problem index score. Change in this measure over time will be assessed.
Measured: 1-, 3-, 6-, 12-months post-randomization
Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report
A self report scale that is aimed at identifying neuropathic pain without the need for clinical examination. Change in this measure over time will be assessed.
Measured: 1-, 3-, 6-, 12-months post randomization
Change in 5-D Itch Scale
Addresses the impact of itch over the previous two week period of time. Change in this measure over time will be assessed.
Measured: 1-, 3-, 6-, 12 months post randomization
Change in Post-Traumatic Stress Disorder Checklist-Civilian version
A 17-item scale that measures each of the Diagnostic and Diagnostic and Statistical Manual-IV (DSM-IV) symptoms of Post Traumatic Stress Disorder (PTSD). Change in this measure over time will be assessed.
Measured: 1-, 3-, 6-, 12-month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelley A. Wiechman, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828541
- Sponsor's protocol ID
- STUDY00000542
- Status last verified
- May 2017
- First submitted
- 29 Mar 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries
- ClinicalTrials.gov ID
- NCT01828541
- Acronym / sponsor ID
- STUDY00000542
- Conditions
- Burns
- Keywords
- Burn injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Apr 2013 (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 determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. Primary hypothesis: Hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year post-burn injury.
Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and fewer symptoms of Post Traumatic Stress Disorder (PTSD).
Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the gabapentin doses and have lower average pain scores than those in the control group.
Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early after injury will report lower rates of neuropathic pain and itch than subjects who will be enrolled in the study and receive hypnosis later in the healing process.
Detailed description
This is a randomized, controlled study comparing two groups of subjects, those in the control (standard care) group and those in the experimental group (hypnosis).
Control subjects will receive treatment as usual, which consists of a standardized protocol for treating post-burn itch. This protocol is based on past research and combines medications in a stepped approach that establishes therapeutic decisions based on clearly defined criteria.
Subjects randomized to the experimental group will undergo four sessions of live hypnosis completed over a two month period. They will be provided with a Compact Disk (CD) of each session and instructed to listen to it daily. Post-hypnotic suggestions will address uncomfortable sensations, with additional suggestions for improved sleep and well-being. Subjects may be inpatient or outpatients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: Standard of CareSubjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications. |
| Hypnosis Condition | Experimental | Behavioral: HypnosisSubjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old
- Ability to provide informed consent for study participation
- ability to read and understand English
- Undergoing pharmacologic therapy for burn related itch according to the standard itch protocol
- Scoring of 4 out of 10 on the Numerical Rating Scale for average itch or pain
Key exclusion criteria (5 listed)
- Age less than 18 or greater than 65
- Inability to provide informed consent
- Inability to read or understand English
- Delirium
- History of mania, paranoia, dissociation and current suicidal ideation
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 |
|---|---|---|
| HypnosisPatients in this group will receive standard care plus 4 sessions of hypnosis. | Behavioural | Hypnosis Condition |
| Standard of Care | Other | Standard Care |
Primary outcome
Change in Numerical Rating Scale for Average Itch
Time frame: 48 hours, 1-, 3-, 6-, 12- months post-randomization
Subjects will be asked to rate their average itch intensity over the previous 24-hour period using the 0 (no itch) to 10 (worst itch imaginable) scale. Change in this measures over time will be assessed.
5 secondary outcomes
Change in Numerical Rating Scale for Pain
Time frame: 48 hours, 1-. 3-. 6-, 12-months post-randomization
Change in Medical Outcomes Study of Sleep
Time frame: 1-, 3-, 6-, 12-months post-randomization
Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report
Time frame: 1-, 3-, 6-, 12-months post randomization
Change in 5-D Itch Scale
Time frame: 1-, 3-, 6-, 12 months post randomization
Change in Post-Traumatic Stress Disorder Checklist-Civilian version
Time frame: 1-, 3-, 6-, 12-month post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Burns, run by University of Washington at 1 site in United States.
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 5 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 12 May 2017. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Rating Scale for Average Itch (time frame: 48 hours, 1-, 3-, 6-, 12- months post-randomization). 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 12 May 2017.