Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Defense and Veterans Center for Integrative Pain Management
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pain Intensity
概览
简要总结
This study will evaluate the impact of sleep banking on joint replacement surgery recovery.
详细描述
Sleep is emerging as a target for pain management. The purpose of this study is to determine the feasibility and efficacy of extending sleep (sleep "banking") on self-reported pain outcomes post-surgery. This is a prospective, interventional, between-subjects, randomized study with a control condition. Participants will be patients undergoing knee or hip replacement surgery at Naval Medical Center San Diego. Participants will be randomized to either a sleep banking group, where they attempt to extend nightly sleep in the week leading up to surgery, or to a habitual sleep control group, sleeping in their typical pattern for that same period. Sleep and pain will be monitored daily yn the two weeks pre- and one week post-surgery. After that, they will be sent electronic follow-up sleep and pain questionnaires at 1, 3, 6, 9, and 12 weeks post-surgery. Participants in the sleep banking group will also complete additional questionnaire items on the feasibility and implementation of the sleep banking protocol. Feasibility of sleep banking will be assessed by examination of the sleep between groups during the intervention week, as well as by the analysis of the implementation questions. Efficacy will be assessed by examination of self-reported pain outcomes post-surgery by group. The primary hypothesis is that self-reported pain outcomes will be improved in the sleep banking group as compared to the control group.
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
- Single (Outcomes Assessor)
盲法说明
single-blind
入排标准
- 年龄范围
- 18 Years 至 74 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego
- •Aged 18-74 years
排除标准
- •Individuals \< 18 or \>74 years of age at enrollment
- •Individuals diagnosed with untreated sleep disorders
- •Individuals with scheduled timezone travel or work schedule changes (\>/= 3 hour time change) in the two weeks before surgery
研究组 & 干预措施
Sleep extension
The sleep extension group will add 2 h of sleep per night the week before surgery
干预措施: Sleep banking (Behavioral)
Habitual sleep
The habitual sleep group maintain their usual hours of sleep per night the week before surgery
结局指标
主要结局
Pain Intensity
时间窗: Weeks 1-15
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Pain Medication Use
时间窗: Weeks 1-15
Opioid Use Diary
次要结局
- Physical Function(Weeks 1-15)
- Sleep Disturbance(Weeks 1-15)