Hypnosis for Pain and Itch Following Burn Injuries

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries

Conditions
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Burns

Intervention / Treatment
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* Behavioral: Hypnosis
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Care<br>Subjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications. | Other: Standard of Care<br> <br> |
| Experimental: Hypnosis Condition<br>Subjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period. | Behavioral: Hypnosis<br>* Patients in this group will receive standard care plus 4 sessions of hypnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours, 1-, 3-, 6-, 12- months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 1-, 3-, 6-, 12-month post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn injuries