UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060587 |
|---|---|
| Receipt number | R000069099 |
| Scientific Title | Effect of a Weighted Blanket on Psychological Distress in Adult Patients Undergoing Initial Outpatient Chemotherapy: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/05 13:09:22 |
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Basic information
Public title
A Study on the Effects of a Weighted Blanket in Psychological Distress in Adult Patients Receiving Outpatient Chemotherapy for the First Time
Acronym
A Study on the Effects of a Weighted Blanket in Psychological Distress in Adult Patients Receiving Outpatient Chemotherapy for the First Time
Scientific Title
Effect of a Weighted Blanket on Psychological Distress in Adult Patients Undergoing Initial Outpatient Chemotherapy: A Randomized Crossover Trial
Scientific Title:Acronym
CALM-WB trial / Chemotherapy, Anxiety (Psychological distress), Lowering Method using Weighted Blanket
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Surgery in general | Psychiatry |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological changes in adult patients undergoing initial outpatient chemotherapy will be assessed using a visual analog scale (VAS) based mental tension score.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | 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 sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Tanaka |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Nursing
Zip code
612-8555
Address
1-1 Mukaibata-cho, Fukakusa, Fushimi-ku, Kyoto-shi, Kyoto 612-8555, Japan
TEL
075-641-9161
404-2syomu@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Tanaka |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Nursing
Zip code
612-8555
Address
1-1 Mukaibata-cho, Fukakusa, Fushimi-ku, Kyoto-shi, Kyoto 612-8555, Japan
TEL
075-641-9161
Homepage URL
1228m1228m@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaibata-cho, Fukakusa, Fushimi-ku, Kyoto-shi, Kyoto 612-8555, Japan
Tel
075-641-9161
404-rinri@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069099
