Primary Total Hip ArthroplastyPhase 4NCT03968939

Total Joint Arthroplasty and Sleep

A Phase 4 study testing Diphenhydramine (Benadryl), Melatonin and Sleep Hygiene Education in people with Primary Total Hip Arthroplasty and Primary Total Knee Arthroplasty, run by James A. Keeney at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty
What is being tested?: Diphenhydramine (Benadryl), Melatonin and Sleep Hygiene Education
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 22 May 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients undergoing elective primary total hip or knee arthroplasty

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Vicki L Jones
Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training

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

Conditions: Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty
Being tested: Diphenhydramine (Benadryl), Melatonin, Sleep Hygiene Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diphenhydramine (Benadryl)Drug
Oral Diphenhydramine (Benadryl), 25 mg
MelatoninDietary supplement
Oral Melatonin, 3 mg
Sleep Hygiene EducationBehavioural
Brochure containing information about getting a "good night's sleep."

Study groups in NCT03968939
Study group	Role	What they receive
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." Receives: Behavioral: Sleep Hygiene Education
Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)	Active comparator	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." Receives: Drug: Diphenhydramine (Benadryl); Dietary Supplement: Melatonin; Behavioral: Sleep Hygiene Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: Baseline, 2 weeks, 6 weeks and 12 weeks post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201922 May 2022

First posted30 May 2019
Study start1 Oct 2019
Primary completion1 Mar 2022
Study completion22 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03968939
Sponsor's protocol ID: 2013726
Status last verified: Jun 2024
First submitted: 23 May 2019
Last updated: 16 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
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Recruiting
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Degenerative Joint Disease, Osteoarthritis, Hip
Recruiting
Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
Osteoarthritis of Hip

All Primary Total Hip Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
ClinicalTrials.gov ID: NCT03968939
Acronym / sponsor ID: 2013726
Conditions: Primary Total Hip Arthroplasty, Primary Total Knee Arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: James A. KeeneyUniversity, hospital or other
Study start: 1 Oct 2019 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 22 May 2022 (actual)
First posted: 30 May 2019 (actual)
Results: Posted 16 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
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	Behavioral: Sleep Hygiene EducationSleep 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	Drug: Diphenhydramine (Benadryl), Dietary Supplement: Melatonin, Behavioral: Sleep Hygiene EducationParticipants 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."

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients undergoing elective primary total hip or knee arthroplasty

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diphenhydramine (Benadryl)Oral Diphenhydramine (Benadryl), 25 mg	Drug	Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)
MelatoninOral Melatonin, 3 mg	Dietary supplement	Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)
Sleep Hygiene EducationBrochure containing information about getting a "good night's sleep."	Behavioural	Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin), Sleep Hygiene Education

Primary outcome

Epworth Sleepiness Scale (ESS)
Time frame: 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)
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 16 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group (Usual Care)	15	15
Sleep Hygiene Education	26	26
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)	14	14

Primary outcome: Epworth Sleepiness Scale (ESS)

Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Group (Usual Care) n = 15	Sleep Hygiene Education n = 26	Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) n = 14
Baseline	7.73 (4.06)	7.81 (5.04)	8.36 (5.51)
2 Week Follow Up	7.31 (3.66)	8.17 (3.76)	7.30 (4.67)
6 Week Follow Up	8.00 (4.26)	8.36 (4.82)	6.17 (2.21)
12 Week Follow Up	6.40 (3.17)	6.68 (3.74)	8.13 (6.10)

Population analysed: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team

Primary outcome: Pittsburgh Sleep Quality Index (PSQI)

Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Group (Usual Care) n = 15	Sleep Hygiene Education n = 26	Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) n = 14
Baseline	10.13 (4.44)	10.96 (4.77)	12.14 (6.00)
2 Weeks Follow Up	9.46 (3.97)	13.17 (3.50)	12.55 (5.87)
6 Weeks Follow Up	10.38 (5.98)	11.77 (3.46)	6.81 (3.74)
12 Weeks Follow Up	9.4 (3.53)	10.7 (4.41)	7.33 (3.64)

Population analysed: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team

Primary outcome: Visual Analogue Scale (VAS) for Pain

Time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Group (Usual Care) n = 15	Sleep Hygiene Education n = 26	Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin) n = 14
Baseline	4.67 (3.04)	4.46 (2.08)	6.21 (1.93)
2 Week Follow Up	4.31 (2.46)	3.67 (2.00)	4.09 (1.87)
6 Week Follow Up	2.67 (1.67)	2.36 (1.56)	2.45 (1.81)
12 Week Follow Up	1.8 (1.32)	2.55 (1.50)	2.78 (2.95)

Population analysed: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team

Adverse events

Time frame: Adverse events were collected from the time of informed consent to the 12 week follow-ip. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group (Usual Care)	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Sleep Hygiene Education	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Primary Total Hip Arthroplasty

Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Not yet recruiting
The Impact of Regional Motor-sparing Blocks on Early Rehabilitation Following Primary Hip or Knee Arthroplasty
Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA), Preoperative Adductor Canal Block (ACB)
Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epworth Sleepiness Scale (ESS) (time frame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03968939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.