Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584955
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers Weighted blankets are heavier blankets that contain inner weight beads The deep pressure stimulation induced by these blankets can have a calming effect
Detailed Description:
Primary Objective
To determine the feasibility of using weighted blankets to improve Sleep Disturbances SD for patients with hematological malignancies in an outpatient setting
Secondary Objectives
To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 -2 days
To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index ISI score
To explore the response rate in anxiety where response is defined as a minimum of one-point change in the ESAS anxiety score between baseline and day 7 -2 days after the use of weighted blankets
To explore if patients are satisfied with the use of weighted blankets as determined by a positive response to at least 2 of the 5 patient satisfaction questions
To assess safety using NCI CTCAE v5
To determine the feasibility of using weighted blankets to improve Sleep Disturbances SD for patients with hematological malignancies in an outpatient setting
Secondary Objectives
To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 -2 days
To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index ISI score
To explore the response rate in anxiety where response is defined as a minimum of one-point change in the ESAS anxiety score between baseline and day 7 -2 days after the use of weighted blankets
To explore if patients are satisfied with the use of weighted blankets as determined by a positive response to at least 2 of the 5 patient satisfaction questions
To assess safety using NCI CTCAE v5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None