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Hypnosis for Pain and Itch Following Burn Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828541
Recruitment Status : Unknown
Verified May 2017 by Shelley A. Wiechman, University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2013
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Shelley A. Wiechman, University of Washington

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.


Condition or disease Intervention/treatment Phase
Burns Behavioral: Hypnosis Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries
Study Start Date : May 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Itching

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828541


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
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Responsible Party: Shelley A. Wiechman, Associate Professor, Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT01828541    
Other Study ID Numbers: STUDY00000542
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shelley A. Wiechman, University of Washington:
Burn injuries
Additional relevant MeSH terms:
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Burns
Wounds and Injuries