Perception of Unpleasant Sensations During Study Procedures in ALS Patients (PESALS)

November 17, 2025 updated by: Istituto Auxologico Italiano

Perception of Unpleasant Sensations in Patients With Amyotrophic Lateral Sclerosis During Procedures Performed in Clinical Trials

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).

Study Overview

Status

Completed

Conditions

Amyotrophic Lateral Sclerosis

Intervention / Treatment

Other: Interview

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Milan, Italy, 20145
    - Istituto Auxologico italiano IRCSS, San Luca Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of experience of unpleasant sensations or pain Time Frame: At enrollment	Prevalence of reported experience of unpleasant sensations orn pain during study procedures	At enrollment
Study procedure that causes unpleasant sensations or pain Time Frame: At enrollment	Qualitative description of study procedure that causes unpleasant sensations or pain	At enrollment
Duration of unpleasant sensations or pain caused by the study procedure Time Frame: At enrollment	Duration in minutes of unpleasant sensations or pain caused by the study procedure	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HADS score Time Frame: At enrollment	Score on Hospital Anxiety and Depression Scale (HADS) scale	At enrollment
ALSFRS score Time Frame: At enrollment	Score on Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) scale	At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria