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To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (Usual Care) | No Intervention | 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 | Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." |
|
| Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin) | Active Comparator | Participants are given both:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphenhydramine (Benadryl) | Drug | Oral Diphenhydramine (Benadryl), 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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. | Baseline, 2 weeks, 6 weeks and 12 weeks post-op |
| 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. | Baseline, 2 weeks, 6 weeks and 12 weeks post-op |
| Visual Analogue Scale (VAS) for Pain | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain | Baseline, 2 weeks, 6 weeks and 12 weeks post-op |
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Inclusion Criteria:
All patients undergoing elective primary total hip or knee arthroplasty
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vicki L Jones | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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". |
| FG001 | Sleep Hygiene Education | Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." |
| FG002 | Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Participants are given both:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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". |
| BG001 | Sleep Hygiene Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
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. | Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 6 weeks and 12 weeks post-op |
|
Adverse events were collected from the time of informed consent to the 12 week follow-ip
The study used the definition of an adverse event defined by clinicaltrials.gov. Participants were reviewed for any untoward medical occurrences during their study participation. No adverse events were identified over the course of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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". |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicki L Jones | UMissouri - Missouri Orthopaedic Institute | 573-882-7583 | jonesvicki@health.missouri.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2020 | Mar 26, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Melatonin | Dietary Supplement | Oral Melatonin, 3 mg |
|
| Sleep Hygiene Education | Behavioral | Brochure containing information about getting a "good night's sleep." |
|
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
| BG002 | Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Participants are given both:
|
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Joint Arthroplasty (TJA) Cohort | Count of Participants | Participants |
|
| OG001 | Sleep Hygiene Education | Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." |
| OG002 | Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Participants are given both:
|
|
|
| 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. | Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 6 weeks and 12 weeks post-op |
|
|
|
| Primary | Visual Analogue Scale (VAS) for Pain | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain | Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 6 weeks and 12 weeks post-op |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sleep Hygiene Education | Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep." Sleep Hygiene Education: Brochure containing information about getting a "good night's sleep." | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) | Participants are given both:
Diphenhydramine (Benadryl): Oral Diphenhydramine (Benadryl), 25 mg Melatonin: Oral Melatonin, 3 mg Sleep Hygiene Education: Brochure containing information about getting a "good night's sleep." | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| 2 Weeks Follow Up |
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| 6 Weeks Follow Up |
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| 12 Weeks Follow Up |
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| 2 Week Follow Up |
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| 6 Week Follow Up |
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| 12 Week Follow Up |
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