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
Recruiting · NCT07653035 · Interventional (participants receive a specific treatment) · Lead sponsor: Sultan Qaboos Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 caring for those patients. Only nurses who agree to complete the study questionnaire will be included.
Where it is running
1 location listed.
- Sultan Qaboos Comprehensive Cancer Care and Research Center - University Medical City - Muscat, Seeb, Oman