Perception of Unpleasant Sensations During Study Procedures in ALS Patients

Prevalence of experience of unpleasant sensations or pain,Study procedure that causes unpleasant sensations or pain,Duration of unpleasant sensations or pain caused by the study procedure

Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for
 both the patient and their next-of-kin/carers, 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 and/or 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 pain/discomfort frightens
 patients during diagnostic and/or 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 Sundler's
 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).