Clinical trial NCT01828541: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Keywords: Burn injuries
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Numerical Rating Scale for Average Itch
timeFrame: 48 hours, 1-, 3-, 6-, 12- months post-randomization
Secondary outcomes:
measure: Change in Numerical Rating Scale for Pain
timeFrame: 48 hours, 1-. 3-. 6-, 12-months post-randomization
measure: Change in Medical Outcomes Study of Sleep
timeFrame: 1-, 3-, 6-, 12-months post-randomization
measure: Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report
timeFrame: 1-, 3-, 6-, 12-months post randomization
measure: Change in 5-D Itch Scale
timeFrame: 1-, 3-, 6-, 12 months post randomization
measure: Change in Post-Traumatic Stress Disorder Checklist-Civilian version
timeFrame: 1-, 3-, 6-, 12-month post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
References: