Impact of Verbal Compared to Structured Information on Patient's Anxiety and Satisfaction Undergoing Uroflowmetry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Comparison of level of anxiety using modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) in both groups receiving verbal or structured education
研究概览
简要总结
Background: Uroflowmetry (UFM) is a non-invasive initial, simple, and widely performed first-line investigation for the evaluation of lower urinary tract symptoms. Despite its non-invasive nature, uroflowmetry can provoke anxiety and affect satisfaction, often due to misunderstandings about the procedure.
Objective: This randomized control trial aimed to compare the effects of structured versus verbal education on anxiety and satisfaction in patients undergoing uroflowmetry.
Methodology: A single-blind, parallel-arm study will include 48 patients, which will be randomized into structured (brochure) and verbal counseling groups. The modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) will assess anxiety, while satisfaction will be measured by using a questionnaire adapted from Dogun et al. Descriptive statistics, Chi-square, and independent t-tests will be employed for data analysis in spss 23.
详细描述
Introduction:
Lower urinary tract symptoms (LUTS) significantly impact approximately half of men and women aged >40 years. This entity includes storage/overactive bladder symptoms, voiding, and post-micturition symptoms. Burden of this condition is increased from 18.4 to 45.8% in a few decades. This condition has multifactorial etiologies and has a significant impact on quality of life, public health costs, and economic burden.
Uroflowmetry (UFM) is a non-invasive initial, simple, and widely performed first-line investigation for the evaluation of this condition. This investigation is an objective assessment of the patient's symptoms and can also be used to follow the response of treatment on lower urinary tract symptoms. Literature has shown that to obtain true representative results patients should be comfortable. Few studies have identified factors having an impact on the satisfaction of patients undergoing uroflowmetry. In one study is was found that trained and dedicated staff improves patient satisfaction.
Even though non-invasive nature, this investigation can lead to emotional disturbance and anxiety with a reported prevalence of up to 41.3%. Limited literature is reported regarding the relationship between anxiety and patient satisfaction undergoing uroflowmetry with a lack of validated questionnaires in assessing the impact of non-invasive urological tests on these aspects. In this study, to assess anxiety in patients undergoing uroflowmetry modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) will be used as according to Rubilotta et al.,2020 this tool can provide reliable results. To assess satisfaction already designed is used. This patient satisfaction form will be used in this study.
This study is an initial step in highlighting the significance of different methods of counseling and will help in the future to provide effective means of education which will help in obtaining representative pattern of patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •Undergoing uroflowmetry for the first time
- •Patients, who can hear, read and comprehend the education in either Urdu or English language.
排除标准
- •Language barrier
- •Known psychiatric illness
- •Unable to comprehend instructions due to any neurological issue
- •Unable to void adequate volume even after 3 attempts
结局指标
主要结局
Comparison of level of anxiety using modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) in both groups receiving verbal or structured education
时间窗: Will be assessed immediately after counselling by either verbal or structured education in peri investigation period.
Assess level of anxiety by APAIS-M. The score for this tool will minimum be 3 and a maximum be 15 and results will be categorized into three groups; 3-6 no anxiety, 7-10 moderate anxiety, 11-15 severe anxiety
To compare patient satisfaction by patient satisfaction form after uroflowmtery
时间窗: Will be assessed immediately after performing uroflowmetry test (post investigation period) in both groups receiving counselling either through verbal or structured education.
It is an objective assessment of patient satisfaction with provided knowledge by the health care provider. This tool is taken from a study published in 2022 as there is no validated questionnaire available to date to assess satisfaction in patients undergoing uroflowmetry.
次要结局
未报告次要终点
研究者
Ramna Nadeem
Resident/ Trainee in Urology department (Principal investigator))
Aga Khan University Hospital, Pakistan