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 | Recruiting DMC

• 2 other identifiers: CALM-WBCCRC-56-2024 - a
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

blankets; cancer; anxiety; depression; comfort; intravenous infusion; non-pharmacological intervention

Outcome Measures

Primary Outcomes (3)

• Change in Anxiety Using Visual Analog Scale for Anxiety (VAS-A)

  Anxiety will be measured using the Visual Analog Scale for Anxiety (VAS-A). The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates worst possible anxiety. Higher scores represent worse anxiety.

  Baseline (prior to weighted blanket use) and at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.

• Change in Symptom Burden Using Edmonton Symptom Assessment System Revised (ESAS-r)

  Symptoms will be assessed using the Edmonton Symptom Assessment System Revised (ESAS-r), a validated tool measuring multiple symptoms (e.g., pain, fatigue, anxiety, depression). Each symptom is scored from 0 to 10, where higher scores indicate worse symptom severity.

  Baseline (prior to weighted blanket use) and at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.

• Change in Depression, Anxiety, and Stress Using Depression Anxiety Stress Scales (DASS-21)

  Psychological status will be assessed using the Depression Anxiety Stress Scales (DASS-21), which includes three subscales: depression, anxiety, and stress. Each subscale score ranges from 0 to 42 after multiplication, with higher scores indicating worse psychological distress.

  Baseline and on Cycle 3 - At any timepoint during the visit (each cycle is anywhere between 14 days and 28 days) of intravenous anticancer therapy.

Secondary Outcomes (6)

• Patient Satisfaction with Weighted Blanket Use (6-item Likert Scale)

  Given to participants randomized to the weighted blanket arm at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days), depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.

• Change in Heart Rate

  Pre-infusion and post-infusion during Cycle 1, Cycle 2 and cycle 3. (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.

• Feasibility of Weighted Blanket Use Among Nurses (Feasibility Questionnaire)

  Given to nurses caring for participants randomized to the weighted blanket arm at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days), depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.

• Change in Blood Pressure

  Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle depending on standard care).

• Change in Respiratory Rate

  Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).

Study Arms (2)

Weighted Blanket Arm

EXPERIMENTAL

Receives Weighted Blanket

Device: Weighted Blanket

Regular Hospital Blanket (No Weighted Blanket)

ACTIVE COMPARATOR

Patients are offered a regular blanket as per standard of care.

Device: Regular Hospital Blanket

Interventions

Weighted Blanket DEVICE

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.

Weighted Blanket Arm

Regular Hospital Blanket DEVICE

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

Regular Hospital Blanket (No Weighted Blanket)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed cancer patients aged 18 years and older.
• Receiving first-line intravenous anticancer therapy (chemotherapy or immunotherapy or a combination of both) in the daycare unit (adjuvant, neoadjuvant, or palliative).
• Weighting at least 55 kg during obtaining the informed consent. (At least 54 kg before the intervention).
• Able to complete study assessments.
• Speaks Arabic or English.
• Signs Informed consent.

You may not qualify if:

• Prior psychological treatment or psychotherapy (confirmed psychological diagnosis, history of psychotropic medications and previous psychotherapy).
• Currently hospitalized in inpatient units.
• Patients on daily anticancer infusions.
• Positive fall risk assessment.
• Open wounds and recent surgeries/ stoma.
• Enrolled in any other device study or clinical trial during data collection.
• History of:
• Diabetes mellitus
• Respiratory disorders,
• Claustrophobia (Miller et al 2003) Because of the possibility for altered sensory perception,
• Patients who had a diagnosis of peripheral neuropathy or fibromyalgia (Vinson et al. 2020)
• Cognitive impairment
• Eligibility criteria for the nurse's population:
• Day Care Unit nurses will be recruited by convenient sampling and feedback will be sought per patient per visit. The reason to this is because the same nurses maybe caring for multiple patients using the WBs and each patient will provide a different experience for the nurses caring for those patients. Only nurses who agree to complete the study questionnaire will be included.

Sponsors & Collaborators

• Sultan Qaboos Comprehensive Cancer Center: lead

Study Sites (1)

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

Muscat, Seeb, 123, Oman

RECRUITING

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Dr. Huda S Al Awaisi, PhD

  Sultan Qaboos Comprehensive Cancer Care and Research Center

  STUDY DIRECTOR

Central Study Contacts

Aida M Al Kindy, BScN, MQM

CONTACT

+968-97655101; a.alkindy@cccrc.gov.om

Fatma K Al Farsi, BScN

CONTACT

+96892893736; f.alfarsi@cccrc.gov.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 17, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)