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.
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.
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.
Parallel
Weighted Blanket
DeviceWeighted 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.
Regular Hospital Blanket
DeviceThis is a regular hospital blanket which is offered as standard of care to all patients. Patients will choose to apply if needed.
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.
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.
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.
Patient Satisfaction with Weighted Blanket Use (6-item Likert Scale)
Patient satisfaction with the weighted blanket will be assessed using a 6-item questionnaire. Each item is rated on a 3-point Likert scale (0 = Disagree, 1 = Not Sure, 2 = Agree). The total score ranges from 0 to 12, calculated by summing responses across all six items. Higher scores indicate greater patient satisfaction with the weighted blanket. The questionnaire was developed for this study and underwent internal validation for clarity and content by a group of individuals who assessed the items for understandability and relevance prior to study implementation.
Change in Heart Rate
Heart rate will be measured in beats per minute (bpm) before and after intravenous anticancer therapy. The change from pre-infusion to post-infusion will be calculated and compared between the interventional and control groups.
Feasibility of Weighted Blanket Use Among Nurses (Feasibility Questionnaire)
Feasibility will be assessed using a structured questionnaire completed by nurses, evaluating ease of use, safety, and practicality. Responses will be recorded on a Likert scale. (Disagree 0, Not sure 1, Agree 2)
Change in Blood Pressure
Blood pressure (mmHg) will be measured before and after intravenous anticancer therapy. Changes from pre-infusion to post-infusion will be calculated and compared between study groups.
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