UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053537 |
|---|---|
| Receipt number | R000058130 |
| Scientific Title | Effectiveness of weighted blankets for sleep disturbances in intensive care units |
| Date of disclosure of the study information | 2024/02/04 |
| Last modified on | 2024/04/20 11:55:12 |
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Basic information
Public title
Effectiveness of weighted blankets for sleep disturbances in intensive care units
Acronym
Effectiveness of weighted blankets for sleep disturbances in intensive care units
Scientific Title
Effectiveness of weighted blankets for sleep disturbances in intensive care units
Scientific Title:Acronym
Effectiveness of weighted blankets for sleep disturbances in intensive care units
Region
| Japan |
Condition
Condition
Patients admitted to ICU after hepatobiliary-pancreatic surgery (after pancreaticoduodenectomy, hepatectomy, etc.).
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that the use of load blankets improves sleep disturbances in intensive care unit (ICU) patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores on the Japanese version of The Richards-Campbell sleep Questionnaire after a patient spent one night in the ICU.
Key secondary outcomes
Results of sleep state analysis of a wearable device (Fitbit Charge 5TM) after a patient spent one night in the ICU.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The load blanket (Mr. Blue Hangzhou Co., Ltd., Osaka, Japan) closest to the weight of around 10% of the actual body weight will be selected from three different types (4.5 kg, 5.4 kg, and 6.8 kg). The patients will not be told which group they were subjected to. The weight of the linen used may allow patients to estimate which group they themselves belonged to, but it is not possible to compare the weight of the linen with that of other patients. The staff attending to the patient would not be able to tell from the appearance of the bedding which bedding group the patient was using. However, they may notice some difference in the bedding when preparing it because of the difference in weight, but this should be noted in the limitation section.
Translated with www.DeepL.com/Translator (free version)
Interventions/Control_2
The control group spends one night in the ICU on regular linen.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) After hepatobiliary-pancreatic surgery (after pancreaticoduodenectomy, hepatectomy, etc.).
(2)Written consent to participate in the study has been obtained before surgery.
Key exclusion criteria
(1) Patients with a BMI of 30 or greater (due to the increased likelihood of having obstructive apnea)
(2) Patients with a diagnosis of obstructive apnea
(3) Patients after liver transplantation (because of the severity of the disease and the significant difference in patient background from other patients)
(4) Patients diagnosed with dementia and who have difficulty completing the Subjective Sleep Questionnaire.
(5) Patients with sleep disorders.
(6) Patients using sleeping drugs.
(7) Patients who are scheduled to enter ICU with the trachea intubated.
After assignment, patients will be excluded from the analysis if any of the following apply
(1) Patients admitted ICU with the tracheal intubated urgently.
(2) Patients who had a major complication such as postoperative bleeding.
(3) Patients who are discharged from the ICU between admission and 7:00 a.m. the next morning.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
024-547-1342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
024-547-1342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Review Committee
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
Tel
024-547-1111
rs@fmu.ac.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
| 2024 | Year | 02 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058130
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