Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty
Conditions
Brief summary
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
Interventions
Oral Diphenhydramine (Benadryl), 25 mg
DIETARY_SUPPLEMENTMelatonin
Oral Melatonin, 3 mg
BEHAVIORALSleep Hygiene Education
Brochure containing information about getting a good night's sleep.
Sponsors
James A. Keeney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
1. Benadryl + Melatonin Group + Sleep Hygiene Education 2. Sleep Hygiene Education Group 3. Control group (Usual Care)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | Baseline, 2 weeks, 6 weeks and 12 weeks post-op | Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which to rate the participants tendency to become sleepy. * No chance of dozing = 0 * Slight chance of dozing = 1 * Moderate chance of dozing = 2 * High chance of dozing = 3 Total the values of the responses. The total score is based on a scale of 0 to 24. The higher score the higher the chance the participant is experiencing excessive sleepiness. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, 2 weeks, 6 weeks and 12 weeks post-op | The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the nine component scores, providing an overall score ranging from 0 to 27, where lower scores denote a healthier sleep quality. |
| Visual Analogue Scale (VAS) for Pain | Baseline, 2 weeks, 6 weeks and 12 weeks post-op | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group (Usual Care) 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. | 15 |
| Sleep Hygiene Education Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a good night's sleep. | 26 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) 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. | 14 |
| Total | 55 |
Baseline characteristics
| Characteristic | Control Group (Usual Care) | Sleep Hygiene Education | Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Total |
|---|---|---|---|---|
| Age, Continuous | 67.77 Years | 67.19 Years | 66.47 Years | 66.71 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 26 Participants | 14 Participants | 54 Participants |
| Region of Enrollment United States | 15 participants | 26 participants | 14 participants | 55 participants |
| Sex: Female, Male Female | 6 Participants | 18 Participants | 3 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 11 Participants | 28 Participants |
| Total Joint Arthroplasty (TJA) Cohort Total Hip Arthroplasty (THA) | 6 Participants | 8 Participants | 5 Participants | 19 Participants |
| Total Joint Arthroplasty (TJA) Cohort Total Knee Arthroplasty (TKA) | 9 Participants | 18 Participants | 9 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 26 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 26 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 26 | 0 / 14 |
Outcome results
Primary
Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which to rate the participants tendency to become sleepy. * No chance of dozing = 0 * Slight chance of dozing = 1 * Moderate chance of dozing = 2 * High chance of dozing = 3 Total the values of the responses. The total score is based on a scale of 0 to 24. The higher score the higher the chance the participant is experiencing excessive sleepiness.
Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group (Usual Care) | Epworth Sleepiness Scale (ESS) | Baseline | 7.73 score on a scale | Standard Deviation 4.06 |
| Control Group (Usual Care) | Epworth Sleepiness Scale (ESS) | 2 Week Follow Up | 7.31 score on a scale | Standard Deviation 3.66 |
| Control Group (Usual Care) | Epworth Sleepiness Scale (ESS) | 6 Week Follow Up | 8.00 score on a scale | Standard Deviation 4.26 |
| Control Group (Usual Care) | Epworth Sleepiness Scale (ESS) | 12 Week Follow Up | 6.40 score on a scale | Standard Deviation 3.17 |
| Sleep Hygiene Education | Epworth Sleepiness Scale (ESS) | 12 Week Follow Up | 6.68 score on a scale | Standard Deviation 3.74 |
| Sleep Hygiene Education | Epworth Sleepiness Scale (ESS) | Baseline | 7.81 score on a scale | Standard Deviation 5.04 |
| Sleep Hygiene Education | Epworth Sleepiness Scale (ESS) | 6 Week Follow Up | 8.36 score on a scale | Standard Deviation 4.82 |
| Sleep Hygiene Education | Epworth Sleepiness Scale (ESS) | 2 Week Follow Up | 8.17 score on a scale | Standard Deviation 3.76 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Epworth Sleepiness Scale (ESS) | 12 Week Follow Up | 8.13 score on a scale | Standard Deviation 6.1 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Epworth Sleepiness Scale (ESS) | 2 Week Follow Up | 7.30 score on a scale | Standard Deviation 4.67 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Epworth Sleepiness Scale (ESS) | 6 Week Follow Up | 6.17 score on a scale | Standard Deviation 2.21 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Epworth Sleepiness Scale (ESS) | Baseline | 8.36 score on a scale | Standard Deviation 5.51 |
Primary
Pittsburgh Sleep Quality Index (PSQI)
The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the nine component scores, providing an overall score ranging from 0 to 27, where lower scores denote a healthier sleep quality.
Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group (Usual Care) | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 10.13 score on a scale | Standard Deviation 4.44 |
| Control Group (Usual Care) | Pittsburgh Sleep Quality Index (PSQI) | 12 Weeks Follow Up | 9.4 score on a scale | Standard Deviation 3.53 |
| Control Group (Usual Care) | Pittsburgh Sleep Quality Index (PSQI) | 2 Weeks Follow Up | 9.46 score on a scale | Standard Deviation 3.97 |
| Control Group (Usual Care) | Pittsburgh Sleep Quality Index (PSQI) | 6 Weeks Follow Up | 10.38 score on a scale | Standard Deviation 5.98 |
| Sleep Hygiene Education | Pittsburgh Sleep Quality Index (PSQI) | 2 Weeks Follow Up | 13.17 score on a scale | Standard Deviation 3.5 |
| Sleep Hygiene Education | Pittsburgh Sleep Quality Index (PSQI) | 6 Weeks Follow Up | 11.77 score on a scale | Standard Deviation 3.46 |
| Sleep Hygiene Education | Pittsburgh Sleep Quality Index (PSQI) | 12 Weeks Follow Up | 10.7 score on a scale | Standard Deviation 4.41 |
| Sleep Hygiene Education | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 10.96 score on a scale | Standard Deviation 4.77 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Pittsburgh Sleep Quality Index (PSQI) | 12 Weeks Follow Up | 7.33 score on a scale | Standard Deviation 3.64 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 12.14 score on a scale | Standard Deviation 6 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Pittsburgh Sleep Quality Index (PSQI) | 2 Weeks Follow Up | 12.55 score on a scale | Standard Deviation 5.87 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Pittsburgh Sleep Quality Index (PSQI) | 6 Weeks Follow Up | 6.81 score on a scale | Standard Deviation 3.74 |
Primary
Visual Analogue Scale (VAS) for Pain
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group (Usual Care) | Visual Analogue Scale (VAS) for Pain | Baseline | 4.67 score on a scale | Standard Deviation 3.04 |
| Control Group (Usual Care) | Visual Analogue Scale (VAS) for Pain | 2 Week Follow Up | 4.31 score on a scale | Standard Deviation 2.46 |
| Control Group (Usual Care) | Visual Analogue Scale (VAS) for Pain | 6 Week Follow Up | 2.67 score on a scale | Standard Deviation 1.67 |
| Control Group (Usual Care) | Visual Analogue Scale (VAS) for Pain | 12 Week Follow Up | 1.8 score on a scale | Standard Deviation 1.32 |
| Sleep Hygiene Education | Visual Analogue Scale (VAS) for Pain | 12 Week Follow Up | 2.55 score on a scale | Standard Deviation 1.5 |
| Sleep Hygiene Education | Visual Analogue Scale (VAS) for Pain | Baseline | 4.46 score on a scale | Standard Deviation 2.08 |
| Sleep Hygiene Education | Visual Analogue Scale (VAS) for Pain | 6 Week Follow Up | 2.36 score on a scale | Standard Deviation 1.56 |
| Sleep Hygiene Education | Visual Analogue Scale (VAS) for Pain | 2 Week Follow Up | 3.67 score on a scale | Standard Deviation 2 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Visual Analogue Scale (VAS) for Pain | 12 Week Follow Up | 2.78 score on a scale | Standard Deviation 2.95 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Visual Analogue Scale (VAS) for Pain | 2 Week Follow Up | 4.09 score on a scale | Standard Deviation 1.87 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Visual Analogue Scale (VAS) for Pain | 6 Week Follow Up | 2.45 score on a scale | Standard Deviation 1.81 |
| Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Visual Analogue Scale (VAS) for Pain | Baseline | 6.21 score on a scale | Standard Deviation 1.93 |