The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patie… (NCT07653035) | Clinical Trial Compass
RecruitingNot Applicable
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
Oman152 participantsStarted 2025-12-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: for patients
* 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.
Exclusion Criteria for patients:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Anxiety Using Visual Analog Scale for Anxiety (VAS-A)
Timeframe: 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.
2
Change in Symptom Burden Using Edmonton Symptom Assessment System Revised (ESAS-r)
Timeframe: 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.
3
Change in Depression, Anxiety, and Stress Using Depression Anxiety Stress Scales (DASS-21)
Timeframe: 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.