Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06323694 |
| Other study ID # |
Attesa chirurgia-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2022 |
| Est. completion date |
February 16, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Istituto Ortopedico Rizzoli |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
Some authors have investigated the experience of the entire care path through qualitative
studies, interviewing patients also about preoperative experiences , but always in interviews
carried out after the operation.
On the other hand, studies carried out on patients on the waiting list are very rare,
focusing on expectations and predictors of outcome.
To date, however, no qualitative studies have directly involved patients on the waiting list
to investigate their subjective perception of the quality of life, expectations, emotional
state, fears. In particular for two categories of lumbar spinal surgery: arthrodesis and
percutaneous vertebroplasty.
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.
The type of study (qualitative study) is the most suitable for investigating the subjective
perception of a problem and its characteristics from a psychosocial point of view.
The semi-structured interview is the most appropriate tool to allow the exploration of the
patient's subjective point of view.
The tools to describe patients with respect to catastrophization, convictions with respect to
movement, kinesiophobia, anxiety and depression were chosen among the evaluation scales and
questionnaires validated in Italian most used in the clinical setting and suggested by
consensus of experts In order to facilitate the recruitment process, the selection of
subjects will take place in two ways:
1. The patient eligible for the study based on the inclusion and exclusion criteria will be
informed about the study by the doctor during the outpatient visit and the insertion who
visits him and puts him on the waiting list for the intervention; the investigator will
explain to the patient the purpose of the study and will provide him with the form for
informed consent.
Only subjects who have provided their consent will be included in the study.
2. To ensure the recruitment of subjects already included in the list, the staff involved
in the study will identify from the waiting list the subjects who meet the inclusion
criteria and will recruit them.
These subjects will be contacted by telephone by the researchers of the study 1 month after
being placed on the waiting list for vertebroplasty operations and at least 12 months after
being placed on the waiting list for arthrodesis operations to organize an individual
interview.
The interviews will take place on a date and time established according to individual
preferences, to be held at the Rizzoli Orthopedic Institute in a closed room and with no
other people present, in addition to the interviewer and the patient.
Before the interview, an initial "booklet" will be delivered, which constitutes the data
collection form of the study, including:
- personal and anthropometric data, educational qualifications, work activity and data
regarding pain (location and duration);
- the Italian version of the 0-100 Numerical Rating Scale (NRS);
- the Italian version of the Pain Self-Efficacy Questionnaire (PSEQ);
- the Italian version of the Tampa Scale for Kinesiophobia (TSK);
- the Italian version of the Pain Catastrophizing Scale (PCS);
- the Italian version of the Hospital Anxiety and Depression Scale (HADS);
- the Italian version of the Euro Quality of Life Questionnaire (EuroQOL). Once completed,
the questionnaires will be placed in a sealed envelope and delivered to the researcher
interviewer.
The researcher will carry out the semi-structured interview, without being aware of the
results collected during the initial evaluation. The individual interview will aim to
investigate the patient's perception of his state of health and quality of life, his beliefs
about the surgery, waiting time and recovery, the emotional state related to the pathology
and to the intervention.
The in-depth interview will be structured with open questions in order to investigate
patients' ideas during the waiting period for surgery, in particular: perceived health and
quality of life, emotional state, symptom trend and preparation for intervention,
expectations regarding the post-operative period and recovery, fears relating to the
intervention and the post-operative phase, fears related to the current health emergency
situation.
In order to allow the research promoters to discuss and analyze all the answers to the open
questions, the interviews will be audio-recorded with a digital audio recorder and later
transcribed anonymously. The interviews will be simultaneously and independently analyzed by
at least two members of the study group, in order to reach a consensus on emerging codes and
themes. These will be grouped, interpreted and analyzed according to the content analysis
method.
Thanks to the emerging design in qualitative research, the analysis will be carried out
throughout the period of data collection. Sampling will stop when saturation is reached. The
qualitative analysis will then begin with the reading of the transcripts and, based on these
transcripts, the analysis of the thematic content will lead to the identification of
categories and themes. The data will be analyzed in an iterative way, to refine the evolving
themes.
This process will continue until further observations provide new information, thus modifying
the categories and themes. These categories will serve as the basis for a final grid, which
will then be used to analyze the transcripts. The sample of participants investigated should
allow to reach a point where no new categories emerge from the analysis of the transcripts.
Using patient data (generated through interviews) and verification of interpretation by the
multidisciplinary team of researchers, the reliability of the data can be verified. This
research method is derived from previous similar projects. In the design phase of this study,
the researchers and consultants studied the specific topic of the research, in order to reach
a better understanding of what will emerge from the participants.
DATA COLLECTION The data necessary for the research will be collected through the
questionnaires provided to patients and the interview carried out by the researchers. A
special collection report form (CRF) will be used to collect the questionnaire data for each
patient enrolled in the study.
