Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060587) titled 'A Study on the Effects of a Weighted Blanket in Psychological Distress in Adult Patients Receiving Outpatient Chemotherapy for the First Time' on Feb. 6.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - National Hospital Organization Kyoto Medical Center

Condition: Condition - Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effects of deep touch pressure delivered by a weighted blanket on reducing psychological distress in adult patients undergoing outpatient chemotherapy for the first time. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - On days assigned to the intervention condition, participants will be provided with a weighted blanket (WB). After initiation of blanket use, venipuncture and intravenous catheter placement for infusion will be performed by the investigator or a co-investigator, followed by the initiation of chemotherapy. Interventions/Control_2 - On days assigned to the control condition, participants will be provided with a standard blanket routinely used at the study facility upon entering the outpatient chemotherapy unit. After initiation of blanket use, venipuncture and intravenous catheter placement for infusion will be performed by the investigator or a co-investigator, followed by the initiation of chemotherapy.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Adults aged 20 to 90 years who have been informed of their cancer diagnosis. 2. Body weight of 40 kg or greater. 3. Patients receiving outpatient chemotherapy for the first time, with no prior chemotherapy exposure. 4. Patients undergoing chemotherapy at an outpatient chemotherapy center. 5. ECOG performance status of 0 to 2 and capable of verbal and written communication. 6. Patients receiving intravenous chemotherapy with an infusion time of at least 30 minutes. 7. Ability to remain in a supine or seated position for 30 minutes or longer. 8. Ability to understand and communicate in Japanese. Key exclusion criteria - 1. Concurrent participation in another clinical study. 2. Diagnosis of peripheral neuropathy or fibromyalgia that may affect sensory perception. 3. Comorbid diabetes mellitus. 4. Presence of dyspnea. 5. Presence of impaired peripheral circulation. 6. Abnormal blood pressure. 7. Fragile skin or compromised skin integrity, including rashes or open wounds. 8. Claustrophobia. 9. Intravenous chemotherapy with an infusion time of <30 minutes. 10. Subcutaneous chemotherapy administration. 11. Intramuscular chemotherapy administration. 12. Chemotherapy administered in an inpatient setting. 13. Any other condition judged by the principal investigator to make the patient unsuitable for participation. Target Size - 85

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 19 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069099

Disclaimer: Curated by HT Syndication.