Hematopoietic and Lymphoid Cell NeoplasmNCT06089408
Weighted Blanket Use to Reduce Anxiety in Oncology Patients
A study testing Best Practice, Supportive Care and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Supportive Care and Survey Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age and older
- About to begin either targeted or cytotoxic chemotherapy
- Able to comprehend and sign a consent form
- Able to read and complete surveys
- Alert and oriented
Who cannot join
- Currently using a weighted blanket at home
- Non-English speaking
- Peripheral neuropathy
- Fibromyalgia
- Open pressure ulcer
- Recent surgical flap
- Claustrophobic
- Weight 45 kg or less
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Allison De Villiers, MSN, RN, ONC, 614-293-7135, allison.devilliers@osumc.edu
Allison De Villiers, MSN, RN, ONC
About this study
Official title: Weighted Blanket Use in Oncology Patients to Reduce Anxiety
This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy.
SECONDARY OBJECTIVE:
- 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.
- Being tested
- Best Practice, Supportive Care, Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Use a regular blanket
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Use a weighted blanket
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (weighted blanket) | Experimental | Patients use a weighted blanket for 30 minutes during the infusion appointment. Receives: Other: Supportive Care; Other: Survey Administration |
| Arm II (regular blanket) | Active comparator | Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
To test for the effect of the weighted blanket, will fit a mixed model with the post-level of anxiety as the dependent variable and baseline values and treatment (standard or weighted blanket) as predictors. A random effect for patient will be fit to account for the possible correlation of within-patient repeated outcome measures. The models will control for patient gender and age.
Measured: At baseline and 30 minutes after use of either a standard or weighted blanket
Secondary outcomes (3)
Levels of distress using NCCN Distress Thermometer
To test for the effect of the weighted blanket, will fit a mixed model with the post-level of distress as the dependent variable and baseline values and treatment (standard or weighted blanket) as predictors. A random effect for patient will be fit to account for the possible correlation of within-patient repeated outcome measures. The models will control for patient gender and age.
Measured: At baseline and 30 minutes after use of either a standard or weighted blanket
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
Will be binned to create ordinal variables. If they lead to an adequate sample size in each group, clinically relevant cut points will be used for binning. Otherwise, we will bin using outcome medians or terciles, with the choice depending on the distribution of the data collected after blanket use. The categorical representation will be modeled using generalized linear mixed modeling. We will fit ordinal logistic regression models with repeated measures. As with the linear mixed models, baseline values and treatment (standard or weighted blanket) will be predictors, with patient gender and age as control variables.
Measured: At baseline and 30 minutes after use of either a standard or weighted blanket
Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer
Will be binned to create ordinal variables. If they lead to an adequate sample size in each group, clinically relevant cut points will be used for binning. Otherwise, we will bin using outcome medians or terciles, with the choice depending on the distribution of the data collected after blanket use. The categorical representation will be modeled using generalized linear mixed modeling. We will fit ordinal logistic regression models with repeated measures. As with the linear mixed models, baseline values and treatment (standard or weighted blanket) will be predictors, with patient gender and age as control variables.
Measured: At baseline and 30 minutes after use of either a standard or weighted blanket
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Aug 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison De Villiers, Ohio State University Comprehensive Cancer Center
- Investigators
- Allison De Villiers, MSN, RN, ONC, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089408
- Sponsor's protocol ID
- OSU-22313
- Other IDs
- NCI-2023-06974
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weighted Blanket Use in Oncology Patients to Reduce Anxiety
- ClinicalTrials.gov ID
- NCT06089408
- Acronym / sponsor ID
- OSU-22313
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. 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:
- To assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy.
SECONDARY OBJECTIVE:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (weighted blanket) | Experimental | Other: Supportive Care, Other: Survey AdministrationPatients use a weighted blanket for 30 minutes during the infusion appointment. |
| Arm II (regular blanket) | Active comparator | Other: Best Practice, Other: Survey AdministrationPatients use a regular blanket for 30 minutes per standard of care during the infusion appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years of age and older
- About to begin either targeted or cytotoxic chemotherapy
- Able to comprehend and sign a consent form
- Able to read and complete surveys
- Alert and oriented
Key exclusion criteria (8 listed)
- Currently using a weighted blanket at home
- Non-English speaking
- Peripheral neuropathy
- Fibromyalgia
- Open pressure ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUse a regular blanket | Other | Arm II (regular blanket) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveUse a weighted blanket | Other | Arm I (weighted blanket) |
| Survey AdministrationAncillary studies | Other | Arm I (weighted blanket), Arm II (regular blanket) |
Primary outcome
Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket
To test for the effect of the weighted blanket, will fit a mixed model with the post-level of anxiety as the dependent variable and baseline values and treatment (standard or weighted blanket) as predictors. A random effect for patient will be fit to account for the possible correlation of within-patient repeated outcome measures. The models will control for patient gender and age.
3 secondary outcomes
Levels of distress using NCCN Distress Thermometer
Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket
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
Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket
Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer
Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison De Villiers, MSN, RN, ONC principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Supportive Care and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form (time frame: At baseline and 30 minutes after use of either a standard or weighted blanket). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.