NCT06584955

Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients With Hematological Malignancies

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
OTHER	Weighted Blanket	Participants will be given a weighted blanket

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2024-09-05
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States