Hypnosis for Pain and Itch Following Burn Injuries

May 10, 2017 updated by: Shelley A. Wiechman, University of Washington

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care
Subjects in this condition will receive our standard care for itch, which includes a stepped based algorithm of medications.
Other: Standard of Care
Experimental: Hypnosis Condition
Subjects in this condition will receive standard care plus the addition of 4 sessions of hypnosis delivered over a two month period.
Behavioral: Hypnosis
Patients in this group will receive standard care plus 4 sessions of hypnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numerical Rating Scale for Average Itch
Time Frame: 48 hours, 1-, 3-, 6-, 12- months post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numerical Rating Scale for Pain
Time Frame: 48 hours, 1-. 3-. 6-, 12-months post-randomization
Subjects will be asked to rate their average pain intensity over the past 24 hours using the 0(no pain) to 10 (worst pain imaginable) scale. Change in this measure over time will be assessed.
48 hours, 1-. 3-. 6-, 12-months post-randomization
Change in Medical Outcomes Study of Sleep
Time Frame: 1-, 3-, 6-, 12-months post-randomization
This tool measures six different sleep constructs. We will use the 9-item sleep problem index score. Change in this measure over time will be assessed.
1-, 3-, 6-, 12-months post-randomization
Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report
Time Frame: 1-, 3-, 6-, 12-months post randomization
A self report scale that is aimed at identifying neuropathic pain without the need for clinical examination. Change in this measure over time will be assessed.
1-, 3-, 6-, 12-months post randomization
Change in 5-D Itch Scale
Time Frame: 1-, 3-, 6-, 12 months post randomization
Addresses the impact of itch over the previous two week period of time. Change in this measure over time will be assessed.
1-, 3-, 6-, 12 months post randomization
Change in Post-Traumatic Stress Disorder Checklist-Civilian version
Time Frame: 1-, 3-, 6-, 12-month post-randomization
A 17-item scale that measures each of the Diagnostic and Diagnostic and Statistical Manual-IV (DSM-IV) symptoms of Post Traumatic Stress Disorder (PTSD). Change in this measure over time will be assessed.
1-, 3-, 6-, 12-month post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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