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

Samsung Medical Center

Status: Completed

Conditions: Gastrectomy

Treatments: Other: Nurse's dashboard; Other: Alarm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03569332

2018-02-135

Details and patient eligibility

About

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.

Full 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)

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Test Group

Experimental group

Description:

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

Treatment:

Other: Nurse's dashboard

Other: Alarm

Control Group

No Intervention group

Description:

Participants will receive the mobile self-input tool on tablet (to compare the rate with Test group). But it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either.