Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol
NCT ID: NCT04191720
Last Updated: 2019-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2018-11-16
2019-11-30
Brief Summary
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Detailed Description
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A two-arm RCT design will be implemented for this study. A convenience sample of 24 patients will be enrolled with 12 patients in the control and intervention groups based on inclusion criteria. The control group will receive Denver Health's standard of care for patients admitted to its well-known medical stabilization unit for patients with extreme form of eating disorders, while the intervention group will receive both the standard of care and a weighted blanket. A mixed-design ANOVA will be performed to explore differences in the Beck's Anxiety Inventory and Subjective Units of Distress Scale between the intervention and control groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group
The control group, or usual care group, will receive occupational therapy standard of care. Occupational therapy standard of care provide training, education, and therapeutic activities including relaxation strategies. These coping mechanisms are aimed at reducing the impact of anxiety on a patient's performance and participation in necessary and meaningful activities of daily living, refeeding and medical stabilization. Specifically, these interventions will include diaphragmatic and yogic breathing exercises, mindfulness-based cognitive therapy (MBCT) education and exercises, therapeutic restorative yoga activities, occupational therapy group participation, aromatherapy, identifying and promoting engagement in meaningful leisure activities, client-centered sensory diets to provide patients with consistent preferred sensory experiences, and individualized checklists and schedules to grade the self-initiation of effective coping strategies.
No interventions assigned to this group
Weighted blanket group
In the weighted blanket intervention group, patients will receive usual occupational therapy care in addition to a weighted blanket. The patient will be given an appropriately weighted blanket, within 1 lb +/- of 10% of body weight as measured on day of admission. Further, the occupational therapy will provide education to the patient on the use of the weighted blanket. Patients will be free to use the weighted blanket at their discretion, however, during meals, over the shoulders or head, and during ambulation, weighted blanket use will not be permitted.
Weighted blanket
Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety
Interventions
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Weighted blanket
Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety
Eligibility Criteria
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Inclusion Criteria
* Moderate/Major Anxiety per initial evaluation score using BAI
* OT assessment
Exclusion Criteria
18 Years
89 Years
ALL
No
Sponsors
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Denver Health and Hospital Authority
OTHER
Responsible Party
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Rachel Ohene
Occupational Therapist
Principal Investigators
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Rachel Ohene, MOT
Role: PRINCIPAL_INVESTIGATOR
Denver Health Hospital and Authority
Locations
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Denver Health and Hospital Authority
Denver, Colorado, United States
Countries
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References
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Other Identifiers
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18-0596
Identifier Type: -
Identifier Source: org_study_id