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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 152
- Locations
- 1
Study Overview
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.
Detailed Description
Cancer represents a significant public health concern in the Sultanate of Oman and continues to contribute substantially to morbidity and mortality within the population. According to the Ministry of Health (2020), cancer is the fourth leading cause of death in the country, highlighting its considerable and growing burden. The crude incidence rate among Omanis is estimated at 68.3 per 100,000 among males and 79.4 per 100,000 among females, indicating a slightly higher incidence among women.
Among the different types of cancer, breast cancer is the most common, with approximately 35% of cases diagnosed at advanced stages (stage III or IV), which is associated with poorer prognostic outcomes and increased physical and psychological burden. Thyroid cancer and colorectal cancer also contribute significantly to the overall cancer burden in the country.
The management of cancer involves a range of treatment modalities aimed at curing the disease, prolonging survival, or improving quality of life. These include surgery, radiotherapy, and systemic therapies such as chemotherapy, immunotherapy, and hormonal treatments. Among these, chemotherapy remains one of the most widely used approaches due to its effectiveness in targeting malignant cells.
However, despite its benefits, chemotherapy is associated with various adverse effects that can negatively impact both the physical and psychological well-being of patients.
Patients undergoing chemotherapy frequently experience distressing physical symptoms, including nausea, fatigue, pain, and general discomfort. In addition to these physical effects, chemotherapy also has a significant psychological impact.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.