UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057438 |
|---|---|
| Receipt number | R000065477 |
| Scientific Title | Pleasant Response and Motivation for Recovery of the Pre-Breakfast Hand Bathing in Postoperative Patients with Hip Fracture in a Subacute Inpatient Rehabilitation Unit: A Mixed Methods Study |
| Date of disclosure of the study information | 2025/03/29 |
| Last modified on | 2025/03/28 16:58:50 |
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Basic information
Public title
Pleasant Response and Motivation for Recovery of the Pre-Breakfast Hand Bathing in Postoperative Patients with Hip Fracture in a Subacute Inpatient Rehabilitation Unit: A Mixed Methods Study
Acronym
Pleasant Response and Motivation for Recovery of the Pre-Breakfast Hand Bathing in Postoperative Patients with Hip Fracture in a Subacute Inpatient Rehabilitation Unit: A Mixed Methods Study
Scientific Title
Pleasant Response and Motivation for Recovery of the Pre-Breakfast Hand Bathing in Postoperative Patients with Hip Fracture in a Subacute Inpatient Rehabilitation Unit: A Mixed Methods Study
Scientific Title:Acronym
Pleasant Response and Motivation for Recovery of the Pre-Breakfast Hand Bathing in Postoperative Patients with Hip Fracture in a Subacute Inpatient Rehabilitation Unit: A Mixed Methods Study
Region
| Japan |
Condition
Condition
Patients undergoing postoperative rehabilitation for hip fracture
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated how quantitative changes in patients' motivation for recovery relate to their pleasant responses to hand bathing before breakfast, and the qualitative aspects of recovery motivation in patients with hip fractures in a subacute inpatient rehabilitation unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statements made during hand bathing
Narratives recorded during the semi-structured interviews
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hand bathing before breakfast (once a day, for four days)
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have undergone surgery for a hip fracture
2) Patients capable of consuming oral meals during breakfast
3) Patients capable of performing movements such as sitting on the edge of their bed, washing their hands, and eating
4) Patients who could express themselves adequately through meaningful verbal communication
Key exclusion criteria
Patients who reported experiencing discomfort or pain during handwashing or eating activities
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Sugawara |
Organization
Mie Prefectural College of Nursing
Division name
School of Nursing
Zip code
514-0116
Address
1-1-1 Yumegaoka, Tsu, Mie
TEL
059-233-5600
keita.sugawara@mcn.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Sugawara |
Organization
Mie Prefectural College of Nursing
Division name
School of Nursing
Zip code
514-0116
Address
1-1-1 Yumegaoka, Tsu, Mie
TEL
059-233-5600
Homepage URL
keita.sugawara@mcn.ac.jp
Sponsor or person
Institute
Mie Prefectural College of Nursing
Institute
Department
Personal name
Keita Sugawara
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee of St. Luke's International University
Address
10-1 Akashi-chou, Chuo-ku, Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.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
| 2025 | Year | 03 | Month | 29 | 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
24
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
For planned submission of a paper.
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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065477
