Efficacy of a Sleep Hygiene Toolkit for Patients in ARU
Primary Purpose
Sleep Disturbance, Sleep Disorder, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Hygiene Toolkit
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disturbance focused on measuring Occupational Therapy, Sleep, ARU, ADL, Rehab, sensory, cognitive behavior therapy, assistive devices, environmental disturbances
Eligibility Criteria
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
Sites / Locations
- Keck Medical Center of USC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Efficacy of a sleep hygiene toolkit in ARU
Arm Description
Pre/post of intervention group (no control)
Outcomes
Primary Outcome Measures
Richards-Campbell Sleep Questionnaire
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05541692
First Posted
September 2, 2022
Last Updated
September 12, 2022
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT05541692
Brief Title
Efficacy of a Sleep Hygiene Toolkit for Patients in ARU
Official Title
Efficacy of a Sleep Hygiene Toolkit for Patients in Acute Rehabilitation Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 4, 2022 (Actual)
Study Completion Date
July 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Sleep Disorder, Insomnia, Critical Illness Myopathy
Keywords
Occupational Therapy, Sleep, ARU, ADL, Rehab, sensory, cognitive behavior therapy, assistive devices, environmental disturbances
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Efficacy of a sleep hygiene toolkit in ARU
Arm Type
Other
Arm Description
Pre/post of intervention group (no control)
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Toolkit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Richards-Campbell Sleep Questionnaire
Description
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.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Publication of data analysis related to intervention study findings
Learn more about this trial
Efficacy of a Sleep Hygiene Toolkit for Patients in ARU
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