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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Weighted Blanket for cancer anxiety?

Research shows that weighted blankets, which provide deep touch pressure, have been used to reduce anxiety in various patient groups, including those receiving chemotherapy. This suggests they might help alleviate anxiety in cancer patients as well. ^{1 2 3 4 5}

How does the treatment of weighted blankets for cancer anxiety differ from other treatments?

Weighted blankets are unique because they use deep touch pressure (DTP) to help reduce anxiety, which is different from other treatments like relaxation training or aromatherapy that focus on mental relaxation or scent therapy. This physical approach is novel for cancer patients experiencing anxiety, especially during chemotherapy. ^{1 2 4 6 7}

Research Team

Allison De Villiers, MSN, RN, ONC

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

I am 18 years old or older.

You have the ability to read and respond to surveys.

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

Exclusion Criteria

I have nerve damage in my hands or feet.

My weight is 45 kg or less.

I do not speak English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Weighted Blankets: Anxiety Reduction in Adult Patients Receiving Chemotherapy. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Effect of guided imagery relaxation on anxiety in cervical cancer: randomized clinical trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of therapeutic massage for hospitalized cancer patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Randomised controlled study of relaxation training. [2019]

5. Scotland 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Aromatherapy: The Effect of Lavender on Anxiety and Sleep Quality in Patients Treated With Chemotherapy [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy. [2020]