Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-03-08 @ 1:55 AM
Study NCT ID:
NCT03569332
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2018-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Effect of the Mobile Self-input Tool of Incentive Spirometer on Its Usage by Patients : a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: