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Weighted Blankets for Cancer Anxiety

N/A

Recruiting

Led By Allison De Villiers, MSN, RN, ONC

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years of age and older

About to begin either targeted or cytotoxic chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 30 minutes after use of either a standard or weighted blanket

Awards & highlights

Study Summary

This trial studies if weighted blankets can reduce anxiety and distress during 1st time cancer treatments. Benefits include feeling safe, comforted, and grounded. Deep touch pressure can reduce stress and increase well-being.

Who is the study for?

This trial is for adult cancer patients starting chemotherapy or immunotherapy who can understand and sign a consent form. It's not for those already using weighted blankets, under 45 kg, with certain conditions like fibromyalgia or claustrophobia, non-English speakers, or those with open wounds from recent surgery.Check my eligibility

What is being tested?

The study tests if using weighted blankets during first-time infusions can reduce anxiety compared to regular blankets. Patients' feelings of safety and comfort are measured through surveys to see if the deep touch pressure from the blanket provides a calming effect.See study design

What are the potential side effects?

There may be no direct side effects from using a weighted blanket; however, individuals might experience discomfort due to personal preferences or specific health conditions like claustrophobia or peripheral neuropathy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am starting chemotherapy soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 30 minutes after use of either a standard or weighted blanket

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 30 minutes after use of either a standard or weighted blanket

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 30 minutes after use of either a standard or weighted blanket for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form

Secondary outcome measures

Levels of distress using NCCN Distress Thermometer

Qualitative change in levels of anxiety based on the baseline and 30 min post blanket use scores using State Trait Anxiety Inventory (STAI) for Adults, short form

Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (weighted blanket)Experimental Treatment2 Interventions

Patients use a weighted blanket for 30 minutes during the infusion appointment.

Group II: Arm II (regular blanket)Active Control2 Interventions

Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

289,981 Total Patients Enrolled

Allison De Villiers, MSN, RN, ONCPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this research endeavor for potential participants?

"According to clinicaltrials.gov, this trial is still open for recruitment as of October 17th 2023. The study was first unveiled on August 1st 2023."

Answered by AI

What is the participant count of this research project?

"Yes, according to clinicaltrials.gov, this medical trial is still in the process of enrolling suitable participants. It was first posted on August 1st 2023 and has since been updated last 17th October 2023. 114 patients are sought from a single location for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Weighted Blanket Use to Reduce Anxiety in Oncology Patients

Allison De Villiers 2023. "Weighted Blanket Use to Reduce Anxiety in Oncology Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06089408.