Burns Clinical Trial
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).
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.
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.
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