Skip to content

Effectiveness of weighted blankets for sleep disturbances in intensive care units

Effectiveness of weighted blankets for sleep disturbances in intensive care units - Effectiveness of weighted blankets for sleep disturbances in intensive care units

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053537
Enrollment
50
Registered
2024-02-04
Start date
2023-05-15
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

Patients admitted to ICU after hepatobiliary-pancreatic surgery (after pancreaticoduodenectomy, hepatectomy, etc.).

Interventions

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

Sponsors

Fukushima Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) After hepatobiliary-pancreatic surgery (after pancreaticoduodenectomy, hepatectomy, etc.). (2)Written consent to participate in the study has been obtained before surgery.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Scores on the Japanese version of The Richards-Campbell sleep Questionnaire after a patient spent one night in the ICU.

Secondary

MeasureTime frame
Results of sleep state analysis of a wearable device (Fitbit Charge 5TM) after a patient spent one night in the ICU.

Countries

Japan

Contacts

Public ContactTakayuki Hasegawa

Fukushima Medical University Anesthesiology

masui@fmu.ac.jp024-547-1342

Outcome results

None listed

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