跳至主要内容
临床试验/NCT07519746
NCT07519746已完成不适用

Patient Satisfaction and Quality of Life Among Lower Limb Prosthetic Users in Gaza Governorate During Gaza War

Yeditepe University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年9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
128
试验地点
1
主要终点
Satisfaction With Life Scale (SWLS)

研究概览

简要总结

Prosthetic devices help amputees regain mobility and improve appearance. When patients are satisfied with their prosthesis, they are more likely to use it consistently, leading to better rehabilitation outcomes.

In Gaza, the 2023 Gaza War caused a rise in traumatic amputations and limited access to healthcare and prosthetic services. This makes rehabilitation more difficult, affecting both physical and mental health.

Research on patient satisfaction and quality of life (QoL) among lower limb prosthetic users in Gaza is limited. This study evaluates satisfaction and QoL in this population, aiming to provide information to improve prosthetic care and guide interventions tailored to local needs.

详细描述

Lower limb amputation has significant physical and psychological impacts, affecting mobility, daily activities, and quality of life (QoL). In Gaza, traumatic amputations increased following the 2023 war, limiting access to prosthetic and rehabilitation services.

This a cross-sectional observational study evaluates adult lower limb prosthetic users (≥18 years, using prosthesis ≥6 months) in Gaza. Data is collected via structured questionnaires covering:

  • Part I: Sociodemographic Data - age, gender, BMI, marital status, education, employment, income, residence, living arrangement, healthcare access.
  • Part II: Clinical Characteristics - amputation level and cause, time since amputation, prosthesis type, duration/frequency of use, comorbidities, prosthetic complications, rehabilitation services received.
  • Part III: Patient Satisfaction - satisfaction with healthcare services regarding quality, communication, comfort, and responsiveness, measured using [Prosthetic Satisfaction Questionnaire].
  • Part IV: Prosthetic Satisfaction - comfort, fit, functionality, and durability of prosthesis, assessed with [Prosthetic Satisfaction Questionnaire].
  • Part V: Quality of Life (QoL) - physical, psychological, and social well-being, measured with EQ-5D-5L and Satisfaction with Life Scale (SWLS).

Data analysis will include descriptive statistics for satisfaction and QoL scores, correlations between patient satisfaction and QoL, and associations with sociodemographic variables using regression models.

The study aims to inform prosthetic care delivery and guide context-specific interventions in Gaza, contributing to better functional recovery and psychological adjustment for lower limb amputees.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Adults aged 18 years or older
  • Continuous use of a lower limb prosthesis for at least six months prior to enrollment
  • Ability to understand and respond to questionnaires or interviews

排除标准

  • Cognitive impairments that affect comprehension or communication
  • Medical, neurological, or psychological conditions that prevent completion of study procedures
  • Inability or unwillingness to provide informed consent

研究组 & 干预措施

Participants completed a survey assessing satisfaction .No interventions were performed

Adult participants (≥18 years) completed a survey assessing sociodemographic characteristics, clinical characteristics, patient satisfaction with healthcare and prosthesis, and quality of life (QoL) outcomes. No interventions were performed; this is an observational study.

干预措施: Observational Study - No Intervention (Other)

结局指标

主要结局

Satisfaction With Life Scale (SWLS)

时间窗: Baseline (one-time assessment)

Life satisfaction was assessed using the Satisfaction With Life Scale (SWLS). Total scores range from 5 to 35, with higher scores indicating greater life satisfaction among lower limb prosthetic users in Gaza governorate. The items are: 1. = Strongly Disagree 2. = Disagree 3. = Slightly Disagree 4. = Neither Agree or Disagree 5. = Slightly Agree 6. = Agree 7. = Strongly Agree * 1\. In most ways my life is close to my ideal. * 2\. The conditions of my life are excellent. * 3\. I am satisfied with life. * 4\. So far I have gotten the important things I want in life. * 5\. If I could live my life over, I would change almost nothing.

Prosthetic satisfaction

时间窗: Baseline (one-time assessment)

Prosthetic satisfaction was assessed using a structured interview adapted from the Satisfaction with Prosthesis Questionnaire (SAT-PRO), Prosthesis Evaluation Questionnaire (PEQ), and Trinity Amputation and Prosthesis Experience Scales (TAPES). The interview includes items evaluating satisfaction, comfort, embarrassment during prosthesis use, and expectation fulfillment. Responses are recorded using dichotomous (Yes/No) and ordinal response options, with higher scores indicating greater prosthetic satisfaction and adaptation.

次要结局

  • Quality of life(Baseline (one-time assessment))
  • Health-related quality of life(Baseline (one-time assessment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验