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

ConditionJoint (Knee or Hip Replacement)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorDefense and Veterans Center for Integrative Pain Management

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals scheduled for a joint replacement surgery (knee or hip) at Naval Medical Center San Diego

Aged 18-74 years

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sleep banking

    Behavioral

    The sleep extension group will add 2 hour of sleep per night the week before surgery

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Sleep extensionExperimental treatment 1 intervention
Group B: Habitual sleepNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain Intensity

Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.

Time frame
Weeks 1-15
2

Pain Medication Use

Opioid Use Diary

Time frame
Weeks 1-15

Secondary outcomes

1

Physical Function

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.

Time frame
Weeks 1-15
2

Sleep Disturbance

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.

Time frame
Weeks 1-15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Defense and Veterans Center for Integrative Pain Management

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: