NCT05541692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 2, 2022

Last Update Submit

September 12, 2022

Conditions

Keywords

Occupational TherapySleepARUADLRehabsensorycognitive behavior therapyassistive devicesenvironmental disturbances

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 days

Study Arms (1)

Efficacy of a sleep hygiene toolkit in ARU

OTHER

Pre/post of intervention group (no control)

Behavioral: Sleep Hygiene Toolkit

Interventions

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.

Efficacy of a sleep hygiene toolkit in ARU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

ParasomniasSleep Wake DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomnias

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 15, 2022

Study Start

April 1, 2022

Primary Completion

July 4, 2022

Study Completion

July 4, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations