跳至主要内容
临床试验/NCT04191720
NCT04191720已完成不适用

A Randomized Control Trial to Assess the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa and Avoidant Restrictive Food Intake Disorder: a Study Protocol

Denver Health and Hospital Authority1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Anxiety reduction

研究概览

简要总结

The aim of this study is to conduct a randomized control trial (RCT) to assess the efficacy of weighted blankets (WB), on anxiety for patients with severe anorexia nervosa (AN) and avoidant restrictive food intake disorder (ARFID) in an inpatient medical setting. We hypothesize that using weighted blankets will reduce anxiety in these patient populations.

详细描述

Anorexia nervosa (AN) has one of the highest mortality rates of any psychiatric disorder with anxiety being a common comorbidity. The standard of care for inpatient medical stabilization for patients diagnosed with AN is a multidisciplinary approach with emphasis on nutrition, psychotherapy, and medical management of complaints. Weighted blankets, an example of deep pressure stimulation, have been shown to reduce anxiety. However, not much is known about the effect of weighted blankets in the eating disorder population. Therefore, this randomized control trial (RCT) protocol outlines a study design for assessing the effect of weighted blankets on patients with AN.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinically diagnosed with AN-R, AN-BP, or ARFID upon admission (per Diagnostic and Statistical Manual-V criteria)
  • •Moderate/Major Anxiety per initial evaluation score using BAI
  • •OT assessment

排除标准

  • •Pregnant or nursing mothers

研究组 & 干预措施

Control group

No Intervention

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.

Weighted blanket group

Experimental

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.

干预措施: Weighted blanket (Other)

结局指标

主要结局

Anxiety reduction

时间窗: SUDS are measured during OT evaluation and through study completion, an average of 3 weeks

Subjective Units of Distress Scale (SUDS)

Anxiety reduction

时间窗: BAI measured during OT evaluation and through study completion, an average of 1 year

Beck Anxiety Inventory (BAI)

次要结局

  • Times weighted blankets are used(Behaviors will be documented every 2 hours over the course of treatment, through study completion, an average of 3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel Ohene

Occupational Therapist

Denver Health and Hospital Authority

研究点 (1)

Loading locations...

相似试验

Assessing the Impact of Weighted Blankets on Anxiety... | 临床试验