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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Feasibility and Effectiveness of a Mindfulness Program Delivered by Web to Patients During Hospitalization and Caregivers.

Study Purpose

Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results from examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report when during hospitalized for different disease conditions; these feelings are not related to the pathological condition. Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation, problems with the work schedule ). Nowadays in North American and North European countries, mindfulness practice is offered to patients by multifaith Chaplaincy teams and health-care operators (e.g. physicians, nurses, psychologists), as a way of helping patients come to terms with diagnosis and adjust to their prognosis. To the extent that patients can bear it, instructions are given to keep coming back to the present moment, here and now, to bodily and affective experience, relaxing in it. To that purpose patients are encouraged to accept the situation as it develops, and let go of excessive concerns and unhelpful narratives that undermine the capacity to manage pain, fear and suffering. Moreover, similar programmes are designed for caregivers and the patients' families, aimed at developing their resilience in delivering the support, via face-to-face sessions, and instructions and encouragement for a regular practice at home. In the last years, due to the dramatic emergency for the COVID-19 pandemic, different applications for mindfulness have been realized by specific APPs or web platforms that allow patients to practice mindfulness regularly guided by a physician or an expert in mindfulness: patients can stay at home and mindfulness sessions can be delivered by technological modalities. In different hospitals, protocols have been implemented for the treatment of patients remotely, using specific platforms or APPs. These remote interventions are complementary to the regular face-to-face sessions and they are suitable for most patients and easily applied.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Patients aged between 18 and 70 yrs; patients hospitalized at our neurological department; patients at the day hospital service. Patients (age from 18 to 70 yrs) hospitalized suffering from: Chronic migraine with medication overuse; Neuropathic Pain; Multiple Sclerosis are included into the project and caregivers.

Exclusion Criteria:

patients not able to understand the italian language; patients with confirmed psychiatric comorbidities; patients who are not able to understand the consent module form and sign it; (or patients with mental capacity issues) Caregivers aged between 18-70 yrs old, will be admitted into the study if they fall in the 18-70 years age bracket, and understand the Italian language , in the absence of psychiatric conditions (reported specific therapy)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05623254
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Licia MI Grazzi, MD
Principal Investigator Affiliation Fondazione IRCCS Istituto Neurologico Carlo Besta
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Migraine; Multiple Sclerosis; Motoneuron Disease
Additional Details

Background: Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results from examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report when they are hospitalized for different disease conditions; these states of mind may be experienced independently of the type of pathological condition they are affected by Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation, problems with the work schedule ) Significance: The practice of mindfulness has become common in different clinical applications, pain, anxiety and other kinds of disease. In particular protocols based on mindfulness practice are often combined to pharmacological therapies, as initial findings support the utility of mindfulness intervention to modulate attention and emotional reactions to pain chronification Meditation has a long history of use for increasing calmness and physical relaxation, improving psychological balance, coping with illness, and enhancing overall health and well-being. The practice has the purpose to teach individuals how to maintain focus on a stimulus while simultaneously allowing intruding thoughts/feelings to be acknowledged, but not judged. Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results of examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report during hospitalization for different disease conditions; these states of mind may be experienced independently of the type of pathological condition the patients are affected by. Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation Nowadays in North American and North European countries, mindfulness practice is offered to patients by multifaith Chaplaincy teams and health-care operators (e.g. physicians, nurses, psychologists), as a way of helping them come to terms with the diagnosis and adjust to their prognosis. To the extent that they can bear it, instructions are given to keep coming back to the present moment, here and now, to bodily and affective experience, relaxing in it. To that purpose patients are encouraged to accept the situation as it develops, and let go of excessive concerns and unhelpful narratives that undermine the capacity to manage pain, fear and suffering. Moreover, similar programmes are designed for caregivers and the patients' families, aimed at developing resilience in delivering their support, via face-to-face sessions, and instructions and encouragement for a regular practice at home. In the last years, due to the dramatic emergency for the COVID-19 pandemic, different applications for mindfulness have been realized by specific APPs or web platforms that allow patients to practice mindfulness regularly guided by a physician or an expert in mindfulness: patients can stay at home and mindfulness sessions can be delivered by technological modalities. In several hospitals, different protocols have been implemented for the treatment of patients remotely, using specific platforms or APPs. These remote interventions are complementary to the regular face-to-face sessions and they are suitable for most patients and easily applied.

Arms & Interventions

Arms

Other: TAU + MINDF (Treatment-as -Usual + Mindfulness)

Treatment-as-usual combined with weekly mindfulness sessions delivered on-line for patients and caregivers (a specific platform for on-line sessions will be used)

Interventions

Other: - no comparator - TAU (Treatment-as-usual)

Learning the ability in mindfulness practice by specific measure (FFMQ) changes in FIVE FACET MINDFULNESS QUESTIONNAIRE (FFMQ) compared to baseline): this questionnaire measures the mindfulness ability of patients before and after the APP application (minimum score 113.7-low mindfulness ability=worse outcome ; maximum score 144.3-high mindfulness ability=better outcome) [Time Frame: At Three-six months] Introduction of the mindfulness program during a preliminary face-to-face session to patients and caregivers TAU Weekly mindfulness sessions delivered on-line for patients and caregivers (a specific platform for on-line sessions will be used)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

Milano, , 20133

Site Contact

Licia Grazzi, MD

[email protected]

+39022394

Nearest Location

Site Contact

Licia Grazzi, MD

[email protected]

+39022394


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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Visit NARCOMS

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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