Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions

Phase 4

Completed

• Conditions: Migraine; Neuropathic Pain
• Interventions: Device: Home program

• Registration Number: NCT05101837
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-01
• Study Start: 2023-11-20
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIND-GROUP	Home program	Daily mindfulness sessions on android

Primary Outcome Measures

Name	Time	Method
Adherence at the program	2 months	To test the adherence of patients at the program. This evaluation will be conducted at the end of the program (Morisky, 2008)

Secondary Outcome Measures

Name	Time	Method
Monthly headache days or days with pain and medication intake	at 2 months	Changes in monthly headache days or days with pain and medication intake compared with baseline, by daily diary card to record pain level on a Visual Analogue Scale (VAS) from 0 as no pain to 10 as Maximum pain; also medication intake reporded on the daily diary card.
Self-efficacy	at 2 months	Changes in self-efficacy (by GSE score) (Generalized Self-Efficacy Scale) at 2months from the beginning of the program compared to baseline (minimum score 10-low level of self- efficacy=worse outcome; maximum score 40-high level of self-efficacy=better outcome ) (Scholz, 2002)
FIVE FACET MINDFULNESS	at 2 months	Changes in FFMQ questionnaire FIVE FACET MINDFULNESS QUESTIONNAIRE compared to baseline (Baer, 2006): 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)
System Usability Scale	up to 2 months	Changes in SUS scale (System Usability Scale) at the end of the program (Brooke, 1996): this scale measures the usability of the APP.; (minimum score 0-low usability of the APP=worse outcome; maximum score 100-high usability of the APP=better outcome)

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta; 🇮🇹 Milano, Italia, Italy