Migraine, Neuropathic Pain
Conditions
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.
Interventions
DEVICEHome program
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
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
independent interventional non pharmacological pilot study with APP for mindfulness practice on android
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Outcome results
None listed