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Sleep Hygiene Education for Hip Replacement Surgery
Phase 4
Waitlist Available
Led By James A Keeney, MD
Research Sponsored by James A. Keeney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post-op
Awards & highlights
Study Summary
This trial compares sleep aids to sleep education in order to improve postoperative sleep quality.
Eligible Conditions
- Hip Replacement Surgery
- Total Knee Replacement
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epworth Sleepiness Scale (ESS)
Pittsburgh Sleep Quality Index (PSQI)
Visual Analogue Scale (VAS) for pain
Trial Design
3Treatment groups
Active Control
Group I: Control group (Usual Care)Active Control1 Intervention
Usual care
Group II: Sleep Hygiene EducationActive Control1 Intervention
Sleep Hygiene Education
Group III: Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)Active Control3 Interventions
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) and Sleep Hygiene Education
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Who is running the clinical trial?
James A. KeeneyLead Sponsor
James A Keeney, MDPrincipal InvestigatorUniversity of Missouri Health System, Department of Orthopaedic Surgery
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