Feasibility & Effectiveness of a Specific App to Delivery Mindfulness

Status Not yet recruiting

Clinical Trial Summary

A standardized behavioural approach based on mindfulness delivered mainly by a specific APP on android will be developed and applied for patients with chronic pain conditions, as migraine and neuropathic pain. The aim of this pilot study: The investigators propose a pilot study to enforce the application of a Home-program for patients with different pain conditions, to learn mindfulness practice, added to a regular mindfulness guided face-to-face program, by using the technology with android to receive mindfulness sessions for daily practice and to assess the feasibility and the effectiveness of behavioural approach base on mindfulness delivered with this modality.

Clinical Trial Description

Background and significance Different clinical experiences confirmed the effectiveness of interventions based on the application of standardized behavioural approaches to support pharmacological traditional treatments for pain conditions in the last decades. Also, different clinical experiences were performed by using electronic devices to deliver home-sessions of behavioral approach (mindfulness) to patients that can practice regularly and supported by mindfulness recorded sessions The aspect of feasibility of these treatments is not reported in published studies, but it can be estimated that standardized behavioural therapies are used in helping patients to obtain a better outcome for pain management In particular, the use of technology to deliver behavioral exercises to patients suffering from different pain conditions, as neuropathic pain and migraine, have been reported in the literature of the last decades. Exercise-based on telemedicine and smartphone applications seem appropriate, as they have been recently tested in the management of chronic pain conditions to reinforce the efficacy of pharmacological therapies and to teach patients to manage their pain and to be more conscious about their clinical condition and about the use of drugs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05101837
Study type	Interventional
Source	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Contact	Licia Grazzi, MD
Phone	+39022394
Email	licia.grazzi@istituto-besta.it
Status	Not yet recruiting
Phase	N/A
Start date	October 2021
Completion date	April 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions — BE_BI_MIND_APP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms