protocolSection identificationModule nctId: NCT06325865, orgStudyIdInfo id: 23C305, briefTitle: Perception of Unpleasant Sensations During Study Procedures in ALS Patients, acronym: PESALS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-19, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Prevalence of experience of unpleasant sensations or pain, primaryOutcomes measure: Study procedure that causes unpleasant sensations or pain, primaryOutcomes measure: Duration of unpleasant sensations or pain caused by the study procedure, secondaryOutcomes measure: HADS score, secondaryOutcomes measure: ALSFRS score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico italiano IRCSS, San Luca Hospital, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Martina Sodano, role: CONTACT, phone: +39-02619111, phoneExt: 2937, email: m.sodano@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False