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Burns | Hypnosis for Pain and Itch Following Burn Injuries

Burns research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Burns

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:HypnosisPatients in this group will receive standard care plus 4 sessions of hypnosis.

Other:Standard of Care

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Standard CareSubjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications.

Hypnosis ConditionSubjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period.

Study Status

Active, not recruiting

Start Date: May 2013

Completed Date: September 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in Numerical Rating Scale for Average Itch

Secondary Outcome: Change in Numerical Rating Scale for Pain

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of Washington

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01828541

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