Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323694
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2022-11-10
Brief Title:
Quality of Life Expectations Thoughts and Fears of Patients on the Waiting List for Spinal Surgery
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Quality of Life Expectations Thoughts and Fears of Patients on the Waiting List for Spinal Surgery a Qualitative Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
chirurgia-1
Brief 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 ones 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
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 ones 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
Detailed 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 patients 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 ones 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 patients 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 patients 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
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 patients 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 ones 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None