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临床试验/NCT03683303
NCT03683303已完成不适用

The Mobile Applications (APP) for Patient Education Has Promoted the Knowledge, Skills on the Wound Care and Reduced the Anxiety of Wound Care

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 70 人开始时间: 2016年3月1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
70
主要终点
wound care knowledge

研究概览

简要总结

The purposes of this study were to understand the effects of mhealth App on wound care knowledge, wound care skills, and anxiety related to dressing change when compared to traditional health education before patients discharged from hospital.

详细描述

  1. Research design:

This study employed a single-blind experimental design. Study participants were randomized into the experimental and control groups. Participants in the experimental group used the mHealth App as intervention while those in the control group received normal verbal instructions. The levels of wound care knowledge, skills, and anxiety related to dressing change in the two groups were compared before intervention (T1), after intervention (T2), and before discharge (T3). 2. Study setting & samples:

The recruitment site of this study was conducted in a plastic surgery ward at a 1500-bed university hospital located in Southern of Taiwan. Samples were recruited either hospitalized patients or their primary caregivers from March to December 2016. Inclusion criteria were of Taiwanese nationality, were aged 20 years and above, had a wound classification score of 6-10 points according to Strauss (2000), required self-care of wound at home, and had a habit of using smartphones. Exclusion criteria included special care conditions, such as (1) other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures) and (2) being a special patient, such as one with mental illness. Sample estimation based on the F test of MANOVA statistics was carried out using the G Power 3.1 software. Each group had at least 31 samples (effect size = 0.25, ∝ = 0.05, power = 0.85). A total of 76 participants satisfied the inclusion criteria for this study. There were 6 patients who were not willing to participate in this study; therefore, 35 participants were randomized enrolled in each of the experimental and control groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • aged 20 years and above.
  • wound classification score of 6-10 points according to Strauss (2000).
  • required wound self-care at home or care by their primary caregivers.
  • had a habit of using smartphones.

排除标准

  • other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures).
  • being a special patient, such as one with mental illness.

研究组 & 干预措施

mobile applications (APP)

Experimental

A total of 70 participants were randomized to each group for 35 people, the control group receiving the oral patient education and the experimental group receiving patient education using mobile applications. Both groups collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3).

干预措施: mobile applications (APP) (Behavioral)

oral education

Active Comparator

A total of 70 participants were randomized to each group for 35 people, the control group receiving the oral patient education and the experimental group receiving patient education using mobile applications. Both groups collected data using "Wound Care Knowledge Scale," "Wound Care Skills Scale," "State Trait Anxiety Inventory" and "Heart Rate Variability" at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3).

干预措施: oral education (Behavioral)

结局指标

主要结局

wound care knowledge

时间窗: 20 minutes

wound care knowledge scale was designed by Li (2008) and was used in the studies of Shao (2013) and Liu (2016). The content validity index (CVI) of this 20-item scale was 1.00 for its feasibility, 0.94 for its definiteness and 0.98 for its Appropriateness. A higher score indicates the higher level of wound care knowledge.

次要结局

  • wound care anxiety(20 minutes)
  • High frequency power (HF)(10 minutes)
  • wound care skills(30 minutes)
  • Heart rate (HR)(10 minutes)
  • Low frequency power (LF)(10 minutes)
  • Heart rate variability (HRV)(10 minutes)
  • The ratio of LF/HF(10 minutes)
  • Blood pressure(BP)(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

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