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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSultan Qaboos Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Weighted Blanket
  • Regular Hospital Blanket

Treatment groups

152 Participants
are divided into 2 treatment groups