Hypnosis for Pain and Itch Following Burn Injuries
|ClinicalTrials.gov Identifier: NCT01828541|
Recruitment Status : Unknown
Verified May 2017 by Shelley A. Wiechman, University of Washington.
Recruitment status was: Active, not recruiting
First Posted : April 10, 2013
Last Update Posted : May 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Burns||Behavioral: Hypnosis Other: Standard of Care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2018|
Subjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications.
Other: Standard of Care
Experimental: Hypnosis Condition
Subjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period.
Patients in this group will receive standard care plus 4 sessions of hypnosis.
- 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.
- Change in Numerical Rating Scale for Pain [ Time Frame: 48 hours, 1-. 3-. 6-, 12-months post-randomization ]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 [ Time Frame: 1-, 3-, 6-, 12-months post-randomization ]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 [ Time Frame: 1-, 3-, 6-, 12-months post randomization ]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 [ Time Frame: 1-, 3-, 6-, 12 months post randomization ]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 [ Time Frame: 1-, 3-, 6-, 12-month post-randomization ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828541
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|