Perception of Unpleasant Sensations During Study Procedures in ALS Patients

Amyotrophic Lateral Sclerosis Clinical Trial

— PESALS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325865
• Other study ID #: 23C305
• Status: Recruiting
• Start date: April 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Martina Sodano
• Phone: +3902619111
• Email: m.sodano[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Auxologico italiano IRCSS, San Luca Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of experience of unpleasant sensations or pain	Prevalence of reported experience of unpleasant sensations orn pain during study procedures	At enrollment
Primary	Study procedure that causes unpleasant sensations or pain	Qualitative description of study procedure that causes unpleasant sensations or pain	At enrollment
Primary	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	HADS score	Score on Hospital Anxiety and Depression Scale (HADS) scale	At enrollment
Secondary	ALSFRS score	Score on Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) scale	At enrollment