Hypnosis for Pain and Itch Following Burn Injuries
Primary Purpose
Burns
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypnosis
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burn injuries
Eligibility Criteria
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
Sites / Locations
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard Care
Hypnosis Condition
Arm Description
Subjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications.
Subjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01828541
Brief Title
Hypnosis for Pain and Itch Following Burn Injuries
Official Title
A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Other
Arm Description
Subjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications.
Arm Title
Hypnosis Condition
Arm Type
Experimental
Arm Description
Subjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
Patients in this group will receive standard care plus 4 sessions of hypnosis.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Primary Outcome Measure Information:
Title
Change in Numerical Rating Scale for Average Itch
Description
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.
Time Frame
48 hours, 1-, 3-, 6-, 12- months post-randomization
Secondary Outcome Measure Information:
Title
Change in Numerical Rating Scale for Pain
Description
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.
Time Frame
48 hours, 1-. 3-. 6-, 12-months post-randomization
Title
Change in Medical Outcomes Study of Sleep
Description
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.
Time Frame
1-, 3-, 6-, 12-months post-randomization
Title
Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report
Description
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.
Time Frame
1-, 3-, 6-, 12-months post randomization
Title
Change in 5-D Itch Scale
Description
Addresses the impact of itch over the previous two week period of time. Change in this measure over time will be assessed.
Time Frame
1-, 3-, 6-, 12 months post randomization
Title
Change in Post-Traumatic Stress Disorder Checklist-Civilian version
Description
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.
Time Frame
1-, 3-, 6-, 12-month post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Hypnosis for Pain and Itch Following Burn Injuries
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