A Study on the Effects of a Weighted Blanket in Psychological Distress in Adult Patients Receiving Outpatient Chemotherapy for the First Time

Effect of a Weighted Blanket on Psychological Distress in Adult Patients Undergoing Initial Outpatient Chemotherapy: A Randomized Crossover Trial - CALM-WB trial / Chemotherapy, Anxiety (Psychological distress), Lowering Method using Weighted Blanket

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060587

Enrollment

Registered

2026-02-06

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

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 infusio

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Psychological changes in adult patients undergoing initial outpatient chemotherapy will be assessed using a visual analog scale (VAS) based mental tension score.	—

Countries

Japan

Contacts

Public ContactMasako Tanaka

National Hospital Organization Kyoto Medical Center Department of Nursing

1228m1228m@gmail.com075-641-9161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026