Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)

Not Applicable

Completed

• Conditions: Gastrectomy
• Interventions: Other: Alarm; Other: Nurse's dashboard

• Registration Number: NCT03569332
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia. Half of participants will receive the mobile self-input tool providing alarm, and their practicing rate will be sent to Nurse's Dashboard. While the other half will receive the mobile self-input tool, but it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either.

Detailed Description

1. Background : Active respiratory therapy like incentive spirometer is needed to prevent pulmonary complications for patients undergoing post-operative under general anesthesia. But in many cases, patients don't practicing it for their pain, or they just forget doing it. And medical staffs are having difficulties in checking how well the patients follow the directions for doing incentive spirometer. Insufficient practicing incentive spirometer and deep breathing cause delay their health recovery.

Therefore, we want to make some tools which can encourage the patients' practicing for incentive spirometer and also supply the objective achievement of patients to medical staffs.

2. Objective : This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia.

3. Design: RCT (randomized controlled trial)

4. Setting: In the Department of Gastrointestinal Surgery at the Samsung Medical Center

5. Enrollment : 44 patients undergoing gastrectomy.

6. Intervention 6-1) For study group : participants on study group are received self-input tool with alarm system on tablet.

Alarm is provided only if insufficient practice (less than 10 times/hour) from 9am to 9pm. The practicing rate is sent to Nurse's Dashboard.

6-2) For control group : participants on control group are received self-input tool without alarm on tablet. Their practicing rate is not sent to Nurse's Dashboard.

7. Scoring by practicing incentive spirometer from 9 am to 9 pm. (Only when a subject practiced more than 10 times per hour, the subject get 10 points) (Full score 240)

8. Study period : for 48hrs from one day to 3rd day after patient's operation

9. Satisfaction survey (SUS) after study(3rd day after operation)

Study Timeline

• Study Start: 2018-04-16
• Primary Completion: 2018-05-17
• Study First Submitted: 2018-05-25
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-06-26
• Study Completion: 2018-07-10
• Last Update Submitted: 2018-07-14
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• A subject undergoing total gastrectomy or subtotal gastrectomy by robotic surgery, laparoscopic surgery or open surgery
• A subject who got surgery under general anesthesia
• A Subject receiving a prescription of using incentive spirometer
• A subject who voluntarily agrees and signs

Read More

Exclusion Criteria

• Disorientation
• Unscheduled emergency surgery
• a subject who has difficulty in active breathing exercise due to problems such as heart disease, brain disease, chronic lung disease, etc.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Alarm	Participants will receive the mobile self-input tool providing alarm on tablet, and their practicing rate will be sent to Nurse's Dashboard.
Test Group	Nurse's dashboard	Participants will receive the mobile self-input tool providing alarm on tablet, and their practicing rate will be sent to Nurse's Dashboard.

Primary Outcome Measures

Name	Time	Method
Total number of practicing incentive spirometer that subjects input by themselves on the mobile self-input tool and scoring by practicing incentive spirometer from 9 am to 9 pm.	Only collecting the numbers of practicing between 9 am and 9 pm for two days, from 1st day to 3rd day after operation.	Only when a subject practiced more than 10 times per hour, the subject get 10 points

Secondary Outcome Measures

Name	Time	Method
Collecting subject's medical records related to pulmonary complication	From one day after subject's operation to the date the subject leaves(discharges) the hospital. (Average duration is for 4~5days)	such as body temperature, laboratory results and Chest X-ray.
Satisfaction Survey for mobile self-input tool	3rd day after operation	Scoring by the answers of the Questionnaire of Satisfaction (SUS)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam, Korea, Republic of