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Completed

NCT Number: NCT05101837

Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italia, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home program

Device

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

Primary outcomes

  1. Adherence at the program

    Time frame: 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 outcomes

  1. Monthly headache days or days with pain and medication intake

    Time frame: 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.

  2. Self-efficacy

    Time frame: 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)

  3. FIVE FACET MINDFULNESS

    Time frame: 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)

  4. System Usability Scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions to Patients with Different Kinds of Pain Condition: a Pilot Study

Acronym: BE_BI_MIND_APP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2021
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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