Hypnosis for Pain and Itch Following Burn Injuries

University of Washington

Status: Unknown

Conditions: Burns

Treatments: Other: Standard of Care; Behavioral: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01828541

STUDY00000542

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard Care

Other group

Description:

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

Treatment:

Other: Standard of Care

Hypnosis Condition

Experimental group

Description:

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

Treatment:

Behavioral: Hypnosis