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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021883
Receipt No. R000025160
Scientific Title Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Date of disclosure of the study information 2016/04/12
Last modified on 2017/05/02

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Basic information
Public title Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Acronym Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Scientific Title Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Scientific Title:Acronym Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Region
Japan

Condition
Condition Gastrointestinal surgery
Classification by specialty
Gastrointestinal surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to verify the effects of an ambulation care program based on the perspective of the activities of daily living (daily activity promotion care) by comparing it with an ambulation care program focusing solely on walking (walking promotion care) and to develop a nursing model to promote ambulation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of steps taken, the number of times the patient left their bed, and the number of implemented activities of daily living over the first 3 postoperative days will be measured.
Key secondary outcomes -Physical function, physical comfort, and psychological condition over the first 3 postoperative days
-Incidence of postoperative complications
-Length of postoperative hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Target patients will receive either walking promotion care or daily activity promotion care from the day before surgery through the first 3 postoperative days by ward nurses.
1. Walking promotion care (ambulation care focusing on walking)
1) Day before surgery
A patient pamphlet generally used at the target ward will be used to offer preoperative instructions. The following explanations will be given: (1) the process and flow during hospitalization and surgery, (2) types of postoperative tubes (e.g., intravenous line, surgical drain) inserted in patients' bodies, (3) pain relief using patient-controlled analgesia, (4) timing for postoperatively starting oral intake, and (5) timing for postoperative ambulation. For ambulation, patients will be informed that they will roll over in bed and sit up on the day after surgery and that they will start walking on postoperative day 1.
2) Postoperative days 1-3
(1) Ambulation start day: Postoperative day 1
(2) Establishment of goals with the patients: The degree of walking as an objective will be established (e.g., "walk XX times in the morning and afternoon" or "walk XX times along the corridor").
(3) Nursing support: The ward nurses will provide physical management support and make environmental adjustments so that patients can walk.
(4) Confirm status of achievement: Patients' achievement status will be confirmed by the patients and nurses at the end of the day shift.
Interventions/Control_2 2. Daily activity promotion care (care for achieving ambulation through the activities of daily living)
1) Day before surgery
In addition to the walking promotion care, a patient leaflet that was created by researchers will be handed out to the participants. It will explain the specific details of the activities of daily living that will be postoperatively performed and the expectation that the amount of time getting out of bed will be actively increased while starting these activities in stages. It will also explain that patients should bring items (such as books, PCs, and tools used for hobbies) from home that can be used while out of bed. Exactly where the patients will spend their time out of bed (such as chairs or lounge) will also be explained.
2) Postoperative days 1-3
(1) Ambulation start day: Postoperative day 1
(2) Establishment of goals with the patients: In addition to walking promotion care, goals for the activities of daily living, such as going to the toilet or eating while sitting up, will be established.
(3) Nursing support: The ward nurse will provide physical management support and make environmental adjustments so that the patients can become ambulatory through restarting the activities of daily living, such as going to the toilet, eating, and bathing.
(4) Confirm status of achievement: Patient' achievement status will be confirmed by the patients and nurses at the end of the day shift.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled to undergo gastrointestinal (excluding the esophagus) resection under general anesthesia
Key exclusion criteria 1. Preoperative impairment of the activities of daily living
2. Unable to have verbal communication
3. Disorders of consciousness
4. Postoperative admission to the intensive care unit (ICU)
5. Postoperative activity restrictions
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masashi Katogi
Organization St.Luke's International University
Division name Graduate School of Nursing Science
Zip code
Address 10-1 Akashi-cho Chuou-ku, Tokyo
TEL 03-3543-6391
Email m-katogi@slcn.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masashi Katogi
Organization St.Luke's International University
Division name Graduate School of Nursing Science
Zip code
Address 10-1 Akashi-cho Chuou-ku, Tokyo
TEL 03-3543-6391
Homepage URL
Email m-katogi@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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
2016 Year 04 Month 12 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 Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 12 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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