Joint (Knee or Hip Replacement)
Conditions
Keywords
sleep banking, sleep extension, chronic pain, recovery
Brief summary
This study will evaluate the impact of sleep banking on joint replacement surgery recovery.
Detailed description
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.
Interventions
BEHAVIORALSleep banking
The sleep extension group will add 2 hour of sleep per night the week before surgery
Sponsors
Defense and Veterans Center for Integrative Pain Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single-blind
Intervention model description
Sleep banking compared to sleep as usual (no intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego * Aged 18-74 years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Weeks 1-15 | Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain. |
| Pain Medication Use | Weeks 1-15 | Opioid Use Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | Weeks 1-15 | Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Physical Function subscale. Each item is scored on a scale 1-5, with 1=without any difficulty and 5=unable to do. Items will be summed and t-scored (0-100), with higher scores denoting less function. |
| Sleep Disturbance | Weeks 1-15 | Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Sleep Disturbance subscale. Each item is scored on a scale 1-5, with 1=not at all and 5=very much. Items will be summed and t-scored (0-100), with higher scores denoting more sleep disturbance. |
Countries
United States
Contacts
CONTACTMary McDuffie, MS RN
Outcome results
None listed