RecruitingNot ApplicableNCT07653035

The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care

The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care; a Randomized Controlled Study (CALM-WB)


Sponsor

Sultan Qaboos Comprehensive Cancer Center

Enrollment

152 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Protocol Title: Protocol Title: The Effect of using Weighted Blanket on anxiety, stress, depression and comfort level among Patients with cancer undergoing intravenous (IV) anticancer therapy and its feasibility of use by nurses compared to routine care; a Randomized controlled study. Study Tools: VAS-A, ESAS-R, DASS-21 and comfort level scale will be used to study the patients' population. A survey will be used to assess the feasibility of using the weighted blankets on patients receiving IV anticancer therapy. Methodology: Consented patients will be stratified per gender then randomized to either ARM1: The interventional arm, Weighted blanket, or ARM2: The control arm, Standard of care. (Regular blanket). The weighted blanket will be administered in the two cycles of IV anticancer therapy for the interventional arm, exploring the temporal trajectory of anxiety, depression, and psychological distress, and investigating the potential of a weighted blanket intervention to mitigate these symptoms. The tools will be administered according to the study protocol. Day Care Unit nurses will be assessed on how feasible they think the blankets are for patients. Expected Outcome: WB is expected to reduce the anxiety in patients undergoing IV anticancer therapy and reduce the nurses' burden when caring for those patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Regular Hospital Blanket and a medical device called Weighted Blanket for people with anxiety depression, solid cancers, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWeighted Blanket

Weighted blankets selection was done to ensure the weight is below 10% of the participants' average weight. For the purpose of this study, researchers will use the 12 lbs (equivalent to 5.44 kg) blankets to account for less than 10% of the patients' average weight. The blankets do not come in free size (Field et. al. 2010). The manufacturer selected was Sommerfly, mainly because of suitability of the product for clinical use (infection control recommendations) and ease of shipping of the products. The blankets are waterproof, breathable, tear-resistant, antimicrobial, flame-resistant and non-toxic. Cleaning involves wiping the surface with approved cleaning wipes or mild soap and water, followed by rinsing and air-drying. If disinfection is required, a 10% bleach solution may be used. Machine washing, drying, or dry cleaning is not permitted.

DEVICERegular Hospital Blanket

This is a regular hospital blanket which is offered as standard of care to all patients. Patients will choose to apply if needed.


Locations(1)

Sultan Qaboos Comprehensive Cancer Care and Research Center - University Medical City

Muscat, Seeb, Oman

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NCT07653035


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