Clinical trial NCT03569332: Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)
Official title: Effect of the Mobile Self-input Tool of Incentive Spirometer on Its Usage by Patients : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrectomy
Keywords: Incentive Spirometer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2018-06-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Only collecting the numbers of practicing between 9 am and 9 pm for two days, from 1st day to 3rd day after operation.
Secondary outcomes:
measure: Collecting subject's medical records related to pulmonary complication
timeFrame: From one day after subject's operation to the date the subject leaves(discharges) the hospital. (Average duration is for 4~5days)
measure: Satisfaction Survey for mobile self-input tool
timeFrame: 3rd day after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam
Study officials:
affiliation: Samsung Medical Center
name: Wonchul Cha, Doctoral
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soh JY, Lee SU, Lee I, Yoon KS, Song C, Kim NH, Sohn TS, Bae JM, Chang DK, Cha WC. A Mobile Phone-Based Self-Monitoring Tool for Perioperative Gastric Cancer Patients With Incentive Spirometer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 19;7(2):e12204. doi: 10.2196/12204.