The Effect of a Urinary Catheter Carrying Bag on Patients' Satisfaction, Body Image, Self-Esteem, and Shame: 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
- 70
- 试验地点
- 2
- 主要终点
- Change in Patient Satisfaction Score
研究概览
简要总结
This study aimed to evaluate the impact of using an innovative urinary catheter carrying bag on the psychosocial well-being of patients who require long-term catheterization. The bag was designed to increase comfort, hygiene, and privacy by concealing the urine bag and minimizing potential embarrassment during daily activities.
A total of 70 patients who had been using an indwelling urinary catheter for at least three weeks were randomly assigned to either an intervention or a control group. The intervention group received a specially designed catheter carrying bag along with training on how to use it, while the control group received standard care without the carrying bag. All participants were monitored over a 21-day period.
Validated assessment tools were used to measure patient satisfaction, body image, self-esteem, and feelings of external shame at baseline and after the intervention period. The study was designed to explore whether the use of the catheter carrying bag could influence these psychosocial outcomes in individuals undergoing long-term catheterization.
This randomized controlled trial was conducted to inform future supportive care practices and explore non-pharmacological interventions that address both the physical and psychosocial needs of patients with indwelling urinary catheters.
详细描述
This randomized controlled trial was conducted between July and December 2023 in the Emergency and Urology departments of X State Hospital. The aim was to investigate the effects of an innovative urinary catheter carrying bag (UCCB) on patients' psychosocial outcomes, including satisfaction, body image, self-esteem, and feelings of shame.
Participants (n=70) were adults aged 18 and older who had been using an indwelling urinary catheter for at least three weeks. Following ethical approval and informed consent, they were randomly assigned to intervention or control groups. The intervention group received a urinary catheter carrying bag along with detailed training, while the control group continued with standard care.
Data collection tools included the Patient Satisfaction-VAS, Body Image Scale, Rosenberg Self-Esteem Scale, and The Other as Shamer Scale. Assessments were conducted before the intervention and after the 21-day follow-up period.
Statistical analyses revealed that patients using the UCCB showed significantly greater improvements in all primary outcomes compared to the control group. Regression models confirmed that the carrying bag had a significant positive effect on patient satisfaction and self-esteem, and a significant negative effect on body image disturbance and shame.
This study provides empirical evidence that a simple, low-cost supportive device can positively influence the psychological well-being of catheter users. The findings suggest that integrating such tools into standard nursing protocols may improve holistic patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Individuals aged 18 years or older
- •Patients with an indwelling urinary catheter in place for at least 3 weeks
- •Ability to communicate and provide informed consent
- •Willingness to participate and comply with study procedures
排除标准
- •Patients with cognitive impairment or communication difficulties
- •Presence of active urinary tract infection at the time of enrollment
- •Severe physical or psychiatric condition interfering with participation
- •Previous participation in a similar catheter-related intervention study
研究组 & 干预措施
Control
Patients received routine catheter care without any intervention.
Intervention
Patients used a specially designed urinary catheter carrying bag for 21 days along with training.
干预措施: Urinary Catheter Carrying Bag Use (Device)
结局指标
主要结局
Change in Patient Satisfaction Score
时间窗: Baseline and Day 21
Patient satisfaction was assessed using a visual analog scale (VAS) at baseline (prior to intervention) and on Day 21 (post-intervention). The aim was to evaluate the impact of the catheter carrying bag on satisfaction related to urinary catheter use.
Change in Patient Satisfaction Score
时间窗: Baseline and Day 21
Patient satisfaction was assessed using a visual analog scale (VAS) at baseline (prior to intervention) and on Day 21 (post-intervention). The aim was to evaluate the impact of the catheter carrying bag on satisfaction related to urinary catheter use.
次要结局
未报告次要终点
研究者
Bahar Ciftci
Assistant Professor, Department of Fundamental of Nursing, Atatürk University
Ataturk University