- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541692
Efficacy of a Sleep Hygiene Toolkit for Patients in ARU
Efficacy of a Sleep Hygiene Toolkit for Patients in Acute Rehabilitation Unit
Sleep Hygiene Study Abstract:
INTRODUCTION Sleep is integral to the health of a person and can have multifaceted contributions to a person including their physical, cognitive, and psychosocial well-being. However, within a recent survey evaluating the sleep perception of patients within an acute rehabilitation unit (ARU), there was a high prevalence of reported sleep disturbances and poor sleep hygiene compared to at home (Davis et al., 2021). In addition, patients within an ARU generally have an extended length of stay-which could mean many nights of poor sleep hygiene. Given the importance of sleep in facilitating a person's health and recovery versus the challenges the hospital environment poses on patient's sleep hygiene, this study aims to examine the efficacy of a sleep hygiene toolkit provided to the patients admitted to ARU. The sleep hygiene toolkit includes multiple non-pharmaceutical resources addressing sensory stimulation and psychological and emotional needs.
OBJECTIVE This study aims to evaluate the perception of sleep quality experienced by ARU patients utilizing the sleep hygiene toolkit. This study hypothesizes that with the use of a sleep hygiene toolkit, patients will report a positive impact on their sleep quality during their hospital stay.
METHODOLOGY This is a within-subjects study design. All eligible participants will be given the sleep hygiene intervention administered for a period of five days. The sleep hygiene toolkit includes multiple resources including assistive devices (ie. eye masks and ear plugs), sensory-based tools (ie. aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie. addressing anxiety and worry), and education and training on sleep hygiene. The visual analog scales on the Richards-Campbell Sleep Questionnaire will be used to assess patient's overall sleep perception pre- and post-intervention.
CONCLUSION Given this prevalent area of need for patients admitted to ARU, occupational therapists (OT) can offer an additional way to address it. According to the Occupational Therapy Practice Framework (2020), OTs are well-equipped to provide comprehensive treatment to promote a person's sleep preparation and sleep participation. The results will determine the efficacy of a sleep hygiene toolkit for ARU patients in addressing their sleep needs-an important component in a patient's health and recovery during their hospital stay.
SIGNIFICANCE OF TOPIC This study aims to highlight the barriers to successful participation in the occupation of sleep and rest for patients admitted to an acute rehabilitation unit (ARU). The creation of this sleep hygiene toolkit is to address a person's sleep preparation and sleep participation. Although sleep quality and its impact are a topic well studied, there is limited study on occupational therapy led interventions aimed to benefit the patient's sleep quality in an ARU setting.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- Keck Medical Center of USC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who have the ability and willingness to give informed consent
- ability to communicate verbally and understand the questionnaires
- ability to use all components of the intervention
- are expected to stay in ARU for more than five days.
Exclusion Criteria:
- Patients with severe cognitive, communication, or behavioral deficits
- received a score of 7 or less out of 15 on the Brief Interview for Mental Status (BIMS) upon admission
- unable to use all components of the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Efficacy of a sleep hygiene toolkit in ARU
Pre/post of intervention group (no control)
|
The sleep hygiene toolkit includes multiple resources including assistive devices (ie.
eye masks and ear plugs), sensory-based tools (ie.
aromatherapy, music, meditation, and breathing techniques), cognitive behavioral therapy (CBT) activities (ie.
addressing anxiety and worry), and education and training on sleep hygiene.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Richards-Campbell Sleep Questionnaire
Time Frame: 5 days
|
Visual analog scale aimed to assess patient's overall sleep perception.
Scale parameters are from 0-100 with the higher number correlating to better sleep perception.
This questionnaire was used pre- and post-intervention.
|
5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-22-00115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Disorder
-
Matrouh UniversitySuez Canal University; Beni-Suef University; University of Bisha, Saudia ArabiaCompletedSleep Disorder | Sleep Hygiene | Sleep Disorder; Insomnia Type | Sleep Disorder in Elderly | Sleep Disorder, Mental Health | Sleep Disorders, Physical HealthEgypt
-
University of ManitobaRecruitingSleepwalking | Sleep Terror | Nightmare Disorder | REM Sleep Behavior Disorder (iRBD) | Confusional ArousalCanada
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSleep Disorder | Diarrhea | Anxiety Disorders | Insomnia | Sleep Initiation and Maintenance Disorders | Anxiety | Sleep Disturbance | Gastrointestinal Dysfunction | Heartburn | Caffeine | Caffeine Withdrawal | Caffeine; Sleep Disorder | Caffeine Dependence | Caffeine-Induced Anxiety Disorder | Caffeine-Induced Sleep... and other conditionsUnited States
-
University of UtahRecruitingREM Sleep Behavior Disorder | Nightmare | Nightmare Disorder With Associated Other Sleep DisorderUnited States
-
Johannes Gutenberg University MainzRecruitingSleep Disorder | Restless Legs Syndrome | Insomnia | Sleep Apnea | Narcolepsy | Idiopathic Hypersomnia | Somnambulism | Sleep Disorder Parasomnia | REM Behavior DisorderGermany
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedCircadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
Beijing Hospital of Traditional Chinese MedicineNot yet recruitingRapid Eye Movement Sleep Behavior Disorder
-
The University of Texas Health Science Center,...Active, not recruitingRapid Eye Movement Sleep Behavior DisorderUnited States
-
Uniformed Services University of the Health SciencesUniversity of Minnesota; Walter Reed National Military Medical Center; The Geneva... and other collaboratorsNot yet recruitingPTSD | Insomnia | Nightmare | TBI | REM Behavior Disorder | Sleep Disorder (Disorder)United States
-
Merck Sharp & Dohme LLCCompletedDyssomnias | Sleep Disorders | Mental Disorder | Sleep Initiation and Maintenance Disorder; Elderly | Sleep Disorder, Intrinsic
Clinical Trials on Sleep Hygiene Toolkit
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Universidad Autónoma de YucatánNot yet recruitingMental Health | Sleep Quality | Students, MedicalMexico
-
Region StockholmActive, not recruiting
-
João BarreiraNot yet recruiting
-
University of MilanCompleted
-
Diskapi Yildirim Beyazit Education and Research...CompletedDiabetes Mellitus, Type 2 | Sleep HygieneTurkey
-
National Taiwan University HospitalCompleted
-
University of MichiganCompleted
-
Children's Hospital of Soochow UniversityNot yet recruitingBehavioural Insomnia of Childhood
-
Virginia Commonwealth UniversitySleep Research Society Foundation (SRSF)CompletedHeart Failure With Preserved Ejection FractionUnited States