Burns Clinical Trial
Official title:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05023135 -
DeepView SnapShot Portable (DV-SSP): Device Training Study
|
||
| Completed |
NCT05276869 -
Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
|
||
| Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT06076031 -
Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing
|
N/A | |
| Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
| Completed |
NCT03113253 -
TRANexamic Acid to Reduce Bleeding in BURN Surgery
|
Phase 4 | |
| Recruiting |
NCT04090424 -
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
|
N/A | |
| Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
| Withdrawn |
NCT03159182 -
Study of Silicone Material Inserts To Treat Burn Scars
|
N/A | |
| Recruiting |
NCT02904941 -
Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns
|
N/A | |
| Completed |
NCT02681757 -
Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns
|
N/A | |
| Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
| Completed |
NCT01437852 -
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
|
Phase 1 | |
| Completed |
NCT01214811 -
Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing
|
Phase 3 | |
| Completed |
NCT01061502 -
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
|
Phase 1/Phase 2 | |
| Terminated |
NCT00822796 -
Thermogard™ Efficacy Trial
|
N/A | |
| Terminated |
NCT00824681 -
Effect of Music Therapy on Families of Burn Patients
|
Phase 1 | |
| Terminated |
NCT00634166 -
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
|
Phase 4 | |
| Terminated |
NCT00464386 -
Continuous Glucose Monitoring (POC) in the ICU
|
N/A | |
| Withdrawn |
NCT00216983 -
Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding
|
N/A |