The Effectiveness of a Care Protocol Developed Using the Star Model on Female Patients With Stress Incontinence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- King's Health Questionnaire
研究概览
简要总结
This study seeks to contribute to nursing practices by developing and stress incontinence care protocol with the help of the Star model and implementing this care protocol for the purpose of standardizing patient care outcomes.
详细描述
To identify the effectiveness of a care protocol developed using the Star model on outcomes in female patients with stress incontinence.
Information and evidence needs to be translated into nursing practice and applied to clinical decision-making in stress incontinence cases. Evidence-based study models such as the Star model provide guidance on using evidence to develop clinical guidelines and care protocols. The Star model is designed to improve patient outcomes by creating a bridge between research and clinical practice. There is currently no published stress incontinence care protocol based on the Star model. Although there is one published study of a care protocol for urinary incontinence, this protocol was not drawn up on the basis of an evidence-based model.
Women that matched the sample criteria were recruited into the study. After their consent was obtained, the women were randomized into an intervention and a control group. The women in the intervention group were provided care according to stress incontinence care protocol. The control group received no intervention during the eight-week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were being female, ≥ 18 years, having an initial diagnosis of SI, being literate, having no sensory disorder affecting communication, and agreeing to participate in the research
排除标准
- •The exclusion criteria were pregnancy, presence of a urinary tract infection and previous treatment for SI. The removal criteria were patient non-compliance with the protocol, failure in contacting the patient and the patient's wish to withdraw from the study.
研究组 & 干预措施
Intervention group
The intervention group received care according to the SICP (Table 2). One of the researchers gave each participant one-on-one education in line with SICP. They were also provided with the booklet that had been prepared in accordance with SICP. The participants were phoned every week for eight weeks and offered counseling within the scope of SICP and then were reevaluated at the end of eight weeks (Post-intervention). The participants were followed from the eighth to the twelfth week without any intervention (4-week post-intervention).
干预措施: intervention group (Behavioral)
Control group
The control group received no intervention during the eight-week intervention period. The control group received standard care. The women were given no educational materials.
结局指标
主要结局
King's Health Questionnaire
时间窗: 20 minutes
This 32-item tool measures quality of life. Scores range from 0 - 100, with low scores indicating good quality of life.
Broome Pelvic Muscle Exercise Self-Efficacy Scale
时间窗: 15 minutes
This instrument was developed to measure perceived self-efficacy in pelvic floor muscle exercise. It consists of 23 items organized in two subscales. The total score ranges from 0 - 100 and scores are classified as follows: ≤ 32(low self-efficacy); 33 55 points (medium self-efficacy); ≥ 56 points (high self-efficacy).
Three-day voiding diary
时间窗: 3 days
This is a semi-objective tool used to record voiding frequency, amount of urine, amount and type of liquid intake, incontinence frequency and the frequency of pad-changing.
One-hour pad test
时间窗: 1 hour
This test provides an objective measure of the quantity of urine leakage in a one-hour period. Before the test, the dry pad is weighed using precision scales and this weight is deducted from the wet weight to give the weight of leaked urine (Krhut et al., 2014). First the patient is given the pre-weighed pad and is then asked to drink 500 cc water and to rest in a seated position for a half-hour. In the following half- hour, the patient stands up and sits down 10 times, coughs 10 times, runs in place for 1 minute, bends to pick something up from the floor 5 times, and then climbs a flight of stairs. After one hour, the pad is taken from the patient and re-weighed on the same precision scales. The weight of the dry pad is deducted from the weight of the wet pad and the weight of urine is recorded.
次要结局
未报告次要终点
研究者
Emel Gülnar
Research Assistant
Kırıkkale University