UMIN-CTR Clinical Trial

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

Gastrointestinal surgery

Classification by specialty

Gastrointestinal surgery

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

St.Luke's International University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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