Perception of Unpleasant Sensations During Study Procedures in ALS Patients

NCT06325865 | Completed

• 1 other identifier: 23C305
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Study procedures

Outcome Measures

Primary Outcomes (3)

• Prevalence of experience of unpleasant sensations or pain

  Prevalence of reported experience of unpleasant sensations orn pain during study procedures

  At enrollment

• Study procedure that causes unpleasant sensations or pain

  Qualitative description of study procedure that causes unpleasant sensations or pain

  At enrollment

• Duration of unpleasant sensations or pain caused by the study procedure

  Duration in minutes of unpleasant sensations or pain caused by the study procedure

  At enrollment

Secondary Outcomes (2)

• HADS score

  At enrollment

• ALSFRS score

  At enrollment

Interventions

Interview OTHER

Interview with ALS patient in which the experiences of unpleasant sensations or pain during study procedures are assessed in a qualitative manner.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Amyotrophic Lateral Sclerosis (ALS) patients who are currently participating in interventional clinical studies or who have particpated in the recent past.

You may qualify if:

• Spinal or bulbar Amyotrophic Lateral Sclerosis (ALS)
• Age \> 18 years
• Adequate understanding of Italian language
• Full understanding of the study
• Informed consent signed
• Current or past participation in interventional clinical studies
• Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score of item # 4 ≥ 2, or score of item #1 ≥ 1

You may not qualify if:

• Clinically relevant cognitive dysfunction
• Inability to answer orally or by writing to the questions of the interview
• Hospital Anxiety and Depression Scale (HADS) scale ≥ 11

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico italiano IRCSS, San Luca Hospital

Milan, 20145, Italy

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: April 19, 2023
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IT (1)