Hypnosis for Pain and Itch Following Burn Injuries

NCT ID: NCT01828541

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-09-30

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

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

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Hypnosis Condition

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

Group Type: EXPERIMENTAL

Hypnosis

Intervention Type: BEHAVIORAL

Patients in this group will receive standard care plus 4 sessions of hypnosis.

Interventions

Hypnosis

Patients in this group will receive standard care plus 4 sessions of hypnosis.

Intervention Type: BEHAVIORAL

Standard of Care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Shelley A. Wiechman

Associate Professor, Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00000542

Identifier Type: -

Identifier Source: org_study_id