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The Impact of Extending Sleep Before Joint-replacement Surgery on Post-surgical Pain

D

Defense and Veterans Center for Integrative Pain Management

Status

Begins enrollment this month

Conditions

Joint (Knee or Hip Replacement)

Treatments

Behavioral: Sleep banking

Study type

Interventional

Funder types

Other

Identifiers

NCT07383584
USUHS 2025-158

Details and patient eligibility

About

This study will evaluate the impact of sleep banking on joint replacement surgery recovery.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Sleep extension
Experimental group
Description:
The sleep extension group will add 2 h of sleep per night the week before surgery
Treatment:
Behavioral: Sleep banking
Habitual sleep
No Intervention group
Description:
The habitual sleep group maintain their usual hours of sleep per night the week before surgery

Trial contacts and locations

1

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Central trial contact

Mary McDuffie, MS RN

Data sourced from clinicaltrials.gov

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