Hypnosis for Pain and Itch Following Burn Injuries

NCT01828541 | Unknown

• 1 other identifier: STUDY00000542
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Burn injuries

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rating Scale for Average Itch

  Subjects will be asked to rate their average itch intensity over the previous 24-hour period using the 0 (no itch) to 10 (worst itch imaginable) scale. Change in this measures over time will be assessed.

  48 hours, 1-, 3-, 6-, 12- months post-randomization

Secondary Outcomes (5)

• Change in Numerical Rating Scale for Pain

  48 hours, 1-. 3-. 6-, 12-months post-randomization

• Change in Medical Outcomes Study of Sleep

  1-, 3-, 6-, 12-months post-randomization

• Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report

  1-, 3-, 6-, 12-months post randomization

• Change in 5-D Itch Scale

  1-, 3-, 6-, 12 months post randomization

• Change in Post-Traumatic Stress Disorder Checklist-Civilian version

  1-, 3-, 6-, 12-month post-randomization

Study Arms (2)

Standard Care

OTHER

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

Other: Standard of Care

Hypnosis Condition

EXPERIMENTAL

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

Behavioral: Hypnosis

Interventions

Hypnosis BEHAVIORAL

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

Hypnosis Condition

Standard of Care OTHER

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Hypnosis; Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 10, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

US (1)