Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01828541
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2013-03-29
Brief Title:
Hypnosis for Pain and Itch Following Burn Injuries
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None