A Randomized Controlled Trial of Hypnosis for Pain and Itch Following Burn Injuries
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Numerical Rating Scale for Average Itch
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age less than 18 or greater than 65
- •Inability to provide informed consent
- •Inability to read or understand English
- •History of mania, paranoia, dissociation and current suicidal ideation
结局指标
主要结局
Change in Numerical Rating Scale for Average Itch
时间窗: 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.
次要结局
- Change in Leeds Assessment of Neuropathic Symptoms and Signs-Self report(1-, 3-, 6-, 12-months post randomization)
- Change in 5-D Itch Scale(1-, 3-, 6-, 12 months post randomization)
- Change in Post-Traumatic Stress Disorder Checklist-Civilian version(1-, 3-, 6-, 12-month post-randomization)
- Change in Numerical Rating Scale for Pain(48 hours, 1-. 3-. 6-, 12-months post-randomization)
- Change in Medical Outcomes Study of Sleep(1-, 3-, 6-, 12-months post-randomization)
研究者
Shelley A. Wiechman
Associate Professor, Rehabilitation Medicine
University of Washington