NCT07653035 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
| NCT ID | NCT07653035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sultan Qaboos Comprehensive Cancer Center |
| Condition | Solid Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2025-12-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Dr. Huda S Al Awaisi, PhD
STUDY DIRECTOR
Sultan Qaboos Comprehensive Cancer Care and Research Center
Frequently Asked Questions
Who can join the NCT07653035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07653035 currently recruiting?
Yes, NCT07653035 is actively recruiting participants. Contact the research team at a.alkindy@cccrc.gov.om for enrollment information.
Where is the NCT07653035 trial being conducted?
This trial is being conducted at Muscat, Oman.
Who is sponsoring the NCT07653035 clinical trial?
NCT07653035 is sponsored by Sultan Qaboos Comprehensive Cancer Center. The principal investigator is Dr. Huda S Al Awaisi, PhD at Sultan Qaboos Comprehensive Cancer Care and Research Center. The trial plans to enroll 152 participants.
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