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临床试验/NCT07383584
NCT07383584
尚未招募
不适用

Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study

Defense and Veterans Center for Integrative Pain Management1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2026年2月15日最近更新:
干预措施Sleep banking

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

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

Experimental

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

No Intervention

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)

研究者

发起方
Defense and Veterans Center for Integrative Pain Management
申办方类型
Other
责任方
Sponsor

研究点 (1)

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