UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021883
Receipt number 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 10:54:58

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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

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

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 or person

Institute

St.Luke's International University

Institute

Department

Personal name



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

Value
https://center6.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