Hypnosis for Pain and Itch Following Burn Injuries

Burns Clinical Trial

Official title:

A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01828541
• Other study ID #: STUDY00000542
• Status: Active, not recruiting
• Phase: N/A
• First received: March 29, 2013
• Last updated: May 10, 2017
• Start date: May 2013
• Est. completion date: September 2018

Study information

• Verified date: May 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Behavioral:
• Hypnosis
Patients in this group will receive standard care plus 4 sessions of hypnosis.

Other:
• Standard of Care

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Numerical Rating Scale for Pain	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
Secondary	Change in Medical Outcomes Study of Sleep	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
Secondary	Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report	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
Secondary	Change in 5-D Itch Scale	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
Secondary	Change in Post-Traumatic Stress Disorder Checklist-Civilian version	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