Weighted Blankets for Cancer Anxiety

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Peripheral neuropathy, Fibromyalgia, Claustrophobic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a weighted blanket during chemotherapy or immunotherapy can reduce anxiety and distress in cancer patients. Weighted blankets offer a sensation similar to a hug, which might lower stress and increase comfort. Participants will use either a weighted blanket or a regular blanket during infusion sessions to determine if a noticeable difference exists. Individuals about to start chemotherapy and not already using a weighted blanket at home might be suitable for this study. As an unphased trial, this study provides a unique opportunity for patients to explore new ways to enhance comfort during treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using weighted blankets to help with anxiety during chemotherapy.

What prior data suggests that using weighted blankets is safe for cancer patients?

Research has shown that weighted blankets can help reduce anxiety. For example, one study found that cancer patients who used weighted blankets for 30 minutes felt less anxious than those who received regular care. This suggests that weighted blankets are generally safe and can help manage anxiety during treatments like chemotherapy.

Other studies have also found that weighted blankets can reduce anxiety in both adults and children undergoing cancer treatments. These results indicate that weighted blankets have a calming effect, making people feel more comfortable and less stressed during medical procedures.

Overall, weighted blankets appear to be a safe and effective way to manage anxiety during medical treatments. No reports of harmful side effects exist, making them a promising option for those looking to reduce anxiety without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for cancer-related anxiety because they offer a non-invasive, comforting alternative to traditional medication-based treatments. Unlike standard options like anti-anxiety drugs, which can have side effects and take time to work, weighted blankets provide immediate soothing pressure that may help reduce anxiety quickly during stressful situations, such as infusion appointments. This approach taps into a simple yet potentially powerful mechanism—deep pressure stimulation—that could enhance relaxation and improve the overall treatment experience for patients.

What evidence suggests that weighted blankets are effective for reducing anxiety in cancer patients?

Research has shown that weighted blankets can help reduce anxiety in people receiving chemotherapy. One study found that patients using a weighted blanket during treatment felt less anxious. In this trial, some participants will use a weighted blanket during their infusion appointments. Another source confirms that these blankets can manage anxiety and distress without any side effects. Experts attribute the calming effect to deep touch pressure, which feels like a hug. Although research specifically on cancer patients is limited, existing findings suggest that weighted blankets may help reduce anxiety during cancer treatment sessions. Meanwhile, other participants in this trial will use a regular blanket as a comparator. ^{2 3 6 7 8}

Who Is on the Research Team?

Allison De Villiers, MSN, RN, ONC

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have the ability to read and respond to surveys.

You are able to understand and agree to the terms of a consent document.

I am mentally alert and aware of my surroundings.

Exclusion Criteria

I have nerve damage in my hands or feet.

My weight is 45 kg or less.

I have been diagnosed with fibromyalgia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a weighted blanket or a regular blanket for 30 minutes during their infusion appointment to assess the effect on anxiety and distress

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and distress levels after blanket use

30 minutes

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (weighted blanket) Experimental Treatment 2 Interventions

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

Group II: Arm II (regular blanket) Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

A randomized controlled trial showed that using a medical-grade therapeutic weighted blanket significantly reduced anxiety in patients undergoing their first and second chemotherapy infusions.

The study confirmed that weighted blankets are safe for patients of various weights and that a visual analog scale is an effective tool for measuring anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weighted Blankets: Anxiety Reduction in Adult Patients Receiving Chemotherapy. Vinson, J., Powers, J., Mosesso, K.[2021]

In a study of 41 cancer patients undergoing chemotherapy or radiation, those who received therapeutic massage experienced significant improvements in pain perception, symptom distress, and sleep quality compared to a control group that only received nurse interaction.

While anxiety levels improved for both groups, the therapeutic massage group showed more comprehensive benefits, suggesting that massage could be an effective complementary therapy for managing symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of therapeutic massage for hospitalized cancer patients. Smith, MC., Kemp, J., Hemphill, L., et al.[2019]

In a 12-week study involving 80 cancer patients, relaxation training did not show significant differences in anxiety, depression, or psychiatric morbidity compared to a control group at the start, but both groups reported increased symptoms over time, especially in women.

Female patients in the control group consistently reported higher levels of anxiety and depression at 6 and 12 weeks, indicating that relaxation training may not have effectively mitigated emotional distress in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled study of relaxation training. Bindemann, S., Soukop, M., Kaye, SB.[2019]

In a randomized controlled trial with 70 patients undergoing chemotherapy, lavender oil aromatherapy significantly reduced trait anxiety levels compared to the control group, suggesting its potential as a supportive therapy for cancer-related anxiety.

The study also found that lavender oil improved sleep quality, as indicated by significant changes in the Pittsburgh Quality Sleep Index (PSQI) measurements before and after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatherapy: The Effect of Lavender on Anxiety and Sleep Quality in Patients Treated With Chemotherapy Ozkaraman, A., Dügüm, Ö., Özen Yılmaz, H., et al.[2022]

In a study involving 52 women with cervical cancer undergoing radiochemotherapy, guided imagery relaxation through virtual reality showed a significant reduction in anxiety traits before the intervention, indicating that participants were experiencing high anxiety levels.

Although the reduction in anxiety levels between the 4th and 12th week of follow-up was not statistically significant, the intervention suggests potential benefits for clinical practice in managing anxiety for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of guided imagery relaxation on anxiety in cervical cancer: randomized clinical trial. Santana, EO., Silva, LDS., Silva, LAAD., et al.[2023]

Benson's Relaxation Response (BRR) significantly improved sleep quality in cancer patients undergoing chemotherapy, with notable enhancements observed at 24 and 48 hours post-intervention.

BRR also effectively reduced anorexia symptoms in the same patient group, with significant improvements measured at 24 and 48 hours, and no side effects were reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Benson's relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial. Harorani, M., Davodabady, F., Farahani, Z., et al.[2020]

Guided imagery, used for 20 minutes daily over one week, significantly reduced anxiety and depression in cancer patients undergoing chemotherapy compared to a control group.

Patients who practiced guided imagery also reported improvements in side effects related to chemotherapy, particularly in pain, insomnia, appetite, and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy. Mahdizadeh, MJ., Tirgari, B., Abadi, OSRR., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32678376/

Anxiety Reduction in Adult Patients Receiving Chemotherapy Anxiety was reduced among patients receiving chemotherapy when the weighted blanket was used. Based on the results, a standard-weight, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06089408

Weighted Blanket Use to Reduce Anxiety in Oncology ... The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions. Detailed Description. PRIMARY OBJECTIVE: I.

3. juniperpublishers.com juniperpublishers.com/pbsij/PBSIJ.MS.ID.556096.php

Effectiveness of Anxiety Reduction in Adults by Weighted ... The studies reviewed here indicate that weighted blanket use, whether a single time or repeated, significantly reduces anxiety without incurring any adverse ...

4. oncnursingnews.com oncnursingnews.com/view/nurse-investigators-on-using-weighted-blankets-to-alleviate-anxiety-during-cancer-treatment-infusions

Nurse Investigators on Using Weighted Blankets to ... Weighted blankets represent an effective tool for reducing patient anxiety during cancer treatments, according to Megan Corbett MSN, RN, NPD-BC, OCN.

5. ons.org ons.org/system/files/journal-article-pdfs/VinsonAugustCJON2020.pdf

Weighted Blankets However, there is a lack of research on the effectiveness of weighted blankets as a method to alleviate anxiety in patients with cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056563/

The effect of weighted blankets on sleep and related disorders Only one study proved that using weighted blankets for 30 minutes could reduce anxiety better than standard care among cancer patients (37). 3.5 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05041075

Effect of Weighted Blankets on Anxiety for Pediatric ... The use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population.

8. oncologynurseadvisor.com oncologynurseadvisor.com/news/weighted-blankets-reduce-anxiety-pediatric-oncology-patients-treatment/

Weighted Blankets Significantly Reduce Anxiety in ... Weighted blankets significantly reduced acute anxiety among pediatric oncology patients following chemotherapy infusion, according to a ...