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

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

Status and phase: Completed; Phase 4

Conditions: Neuropathic Pain; Migraine

Treatments: Device: Home program

Study type: Interventional

Funder types: Other

Identifiers

NCT05101837

BE_BI_MIND_APP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of Neuropathic Pain and Chronic Migraine
• written informed consent

Exclusion criteria

• co-existent severe medical or psychiatric illnesses, documented by specific previous diagnoses
• seizures
• use of opioids

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MIND-GROUP

Experimental group

Description:

Daily mindfulness sessions on android

Treatment:

Device: Home program