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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

NCT07653035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Solid Cancers
  • Anxiety Depression
  • Stress

Interventions

DEVICE

Weighted 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.

DEVICE

Regular 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.

Sponsors & Collaborators

  • Sultan Qaboos Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Dr. Huda S Al Awaisi, PhD · Sultan Qaboos Comprehensive Cancer Care and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2027-06-30
Completion
2027-07-31

Countries

  • Oman

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07653035 on ClinicalTrials.gov