Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery: a Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Descriptive survey for vertebroplasty patients
研究概览
简要总结
The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.
Hypothesis:
Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.
This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.
The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.
The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.
All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.
The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority.
详细描述
Expectations and personal experiences of the patient regarding the state of illness and the path of treatment undertaken are essential for the overall taking into account of the person. In patients undergoing spinal surgery, it has been shown that these factors can influence both perceived patient satisfaction and post-operative outcomes.
In particular, the catastrophization of pain even before surgery has been shown to predict functional disability, postoperative pain and its chronicity.
The literature also highlights that the time spent on the waiting list by patients elected for spinal surgery can influence postoperative pain outcomes and persistence.
It should also be emphasized that, in comparison with candidates for surgery for other districts (hip, knee), patients hospitalized for spinal surgery arrived at the intervention with worse scores on all scales, both physical and mental.
Numerous qualitative studies have investigated various aspects of the patient's subjective experience after surgery: from the experience related to pre- and post-operative rehabilitation programs, to the perspectives on '' introduction of a healthy lifestyle with physical activity ; from the perception of preparation for surgery, to the experience of Enhanced Recovery After Surgery - ERAS.
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
- 否
入选标准
- •Patients on the waiting list for first vertebral arthrodesis or vertebroplasty surgery percutaneous;
- •Age over 18;
- •Good understanding of spoken and written Italian;
- •Obtaining Informed Consent;
- •Possibility to go to the Rizzoli Orthopedic Institute on a date to be agreed for carry out the interview with the researchers.
排除标准
- •Previous spinal surgery;
- •Poor understanding of spoken and written Italian
- •Central or peripheral neurological diseases;
- •Systemic pathologies;
- •Rheumatic pathologies;
- •Neuromuscular pathologies;
- •Neuropsychological deficits that do not allow you to fill in the questionnaires and / or answer fully to the interview.
结局指标
主要结局
Descriptive survey for vertebroplasty patients
时间窗: after 1 month
questionnaire on the personal situation of the patient on the waiting list for vertebroplasty
Descriptive survey for spinal arthrodeses patients
时间窗: after 1 year
questionnaire on the personal situation of the patient on the waiting list for spinal arthrodeses
次要结局
未报告次要终点