Total Joint Arthroplasty and Sleep

James A. Keeney

Status and phase: Completed; Phase 4

Conditions: Primary Total Knee Arthroplasty; Primary Total Hip Arthroplasty

Treatments: Dietary Supplement: Melatonin; Behavioral: Sleep Hygiene Education; Drug: Diphenhydramine (Benadryl)

Study type: Interventional

Funder types: Other

Identifiers

NCT03968939

2013726

Details and patient eligibility

About

To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients undergoing elective primary total hip or knee arthroplasty

Exclusion criteria

1. History of substance abuse
2. Workman's compensation patients
3. Revision joint replacement
4. History of prescription or over-the- counter sleep aid use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups

Control group (Usual Care)

No Intervention group

Description:

Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".

Sleep Hygiene Education

Active Comparator group

Description:

Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."

Treatment:

Behavioral: Sleep Hygiene Education

Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)

Active Comparator group

Description:

Participants are given both: 1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime; 2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."

Treatment:

Drug: Diphenhydramine (Benadryl)

Behavioral: Sleep Hygiene Education

Dietary Supplement: Melatonin