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临床试验/NCT03569332
NCT03569332已完成不适用

Effect of the Mobile Self-input Tool of Incentive Spirometer on Its Usage by Patients : a Randomized Clinical Trial

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

  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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Test Group

Experimental

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

干预措施: Alarm (Other)

Test Group

Experimental

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

干预措施: Nurse's dashboard (Other)

Control Group

No Intervention

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.

结局指标

主要结局

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.

时间窗: 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

次要结局

  • 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))
  • Satisfaction Survey for mobile self-input tool(3rd day after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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