Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325865
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-16
Brief Title:
Perception of Unpleasant Sensations During Study Procedures in ALS Patients
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials
Status:
RECRUITING
Status Verified Date:
2024-03
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:
PESALS
Brief Summary:
Diagnosis of Amyotrophic Lateral Sclerosis ALS is considered a traumatic life event for both the patient and their next-of-kincarers due to the lack of treatment Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide Research protocols may involve routine diagnostic andor therapeutic procedures which the patients may be already aware of and therefore expecting specific sensations These could compromise participation or drop-out rate Despite everything participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures through preferential access compared to other patients
Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials Analysing what type of paindiscomfort frightens patients during diagnostic andor therapeutic procedures including the different methods of administration of the study drug Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale Create and implement an ALS-specific pain scale accounting for its impact on daily activities aiding an interdisciplinary approach of pain management Identify the best pain management strategies and compliance techniques to address ALS not merely in clinical trials Provide the best individualized care for ALS patients improving their quality of life and mental state
This is a descriptive phenomenological study and data will be analyzed according to Sundlers method Based on the experience of the researchers and the recommendations proposed by Sandelowski a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference Data collection will be carried out through in-depth semi-structured interviews recorded 13 open-ended questions after the execution of the procedures
Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials Analysing what type of paindiscomfort frightens patients during diagnostic andor therapeutic procedures including the different methods of administration of the study drug Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale Create and implement an ALS-specific pain scale accounting for its impact on daily activities aiding an interdisciplinary approach of pain management Identify the best pain management strategies and compliance techniques to address ALS not merely in clinical trials Provide the best individualized care for ALS patients improving their quality of life and mental state
This is a descriptive phenomenological study and data will be analyzed according to Sundlers method Based on the experience of the researchers and the recommendations proposed by Sandelowski a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference Data collection will be carried out through in-depth semi-structured interviews recorded 13 open-ended questions after the execution of the procedures
Detailed Description:
None
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