Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089408
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-09-27
Brief Title:
Weighted Blanket Use to Reduce Anxiety in Oncology Patients
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Weighted Blanket Use in Oncology Patients to Reduce Anxiety
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions eg chemotherapy targeted therapy etc to decrease adverse side effects such as anxiety and distress in cancer oncology patients Feeling safe comforted and grounded in the world are some of the benefits noted by individuals who use weighted blankets Deep touch pressure DTP has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged squeezed or held DTP affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions
Detailed Description:
PRIMARY OBJECTIVE
I To assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy
SECONDARY OBJECTIVE
I To assess the efficacy of weighted blankets on distress in patients receiving infusion therapy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients use a weighted blanket for 30 minutes during the infusion appointment
ARM II Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment
I To assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy
SECONDARY OBJECTIVE
I To assess the efficacy of weighted blankets on distress in patients receiving infusion therapy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients use a weighted blanket for 30 minutes during the infusion appointment
ARM II Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-06974 | REGISTRY | CTRP Clinical Trial Reporting Program | None |