Feasibility and Effectiveness of a Mindfulness Program Delivered by Web to Patients During Hospitalization and Caregivers.

NCT05623254 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-03-02

No results posted yet for this study

Summary

Hospitalization is often a traumatic event so stressful for the life of patients. Isolation, loneliness, worries about clinical examinations, results from examinations and final diagnosis, uncertainty about the future are the most common feelings that patients report when during hospitalized for different disease conditions; these feelings are not related to the pathological condition.

Also the discomfort of the caregivers is significant, as the necessities and priorities of the family change significantly during the hospitalization of a member (worries about the future, help and support are not enough to sustain the situation, problems with the work schedule ). Nowadays in North American and North European countries, mindfulness practice is offered to patients by multifaith Chaplaincy teams and health-care operators (e.g. physicians, nurses, psychologists), as a way of helping patients come to terms with diagnosis and adjust to their prognosis. To the extent that patients can bear it, instructions are given to keep coming back to the present moment, here and now, to bodily and affective experience, relaxing in it. To that purpose patients are encouraged to accept the situation as it develops, and let go of excessive concerns and unhelpful narratives that undermine the capacity to manage pain, fear and suffering. Moreover, similar programmes are designed for caregivers and the patients' families, aimed at developing their resilience in delivering the support, via face-to-face sessions, and instructions and encouragement for a regular practice at home.

In the last years, due to the dramatic emergency for the COVID-19 pandemic, different applications for mindfulness have been realized by specific APPs or web platforms that allow patients to practice mindfulness regularly guided by a physician or an expert in mindfulness: patients can stay at home and mindfulness sessions can be delivered by technological modalities. In different hospitals, protocols have been implemented for the treatment of patients remotely, using specific platforms or APPs. These remote interventions are complementary to the regular face-to-face sessions and they are suitable for most patients and easily applied.

Conditions

  • Chronic Migraine; Multiple Sclerosis; Motoneuron Disease

Interventions

OTHER

no comparator - TAU (Treatment-as-usual)

Learning the ability in mindfulness practice by specific measure (FFMQ) changes in FIVE FACET MINDFULNESS QUESTIONNAIRE (FFMQ) compared to baseline): 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) \[Time Frame: At Three-six months\] Introduction of the mindfulness program during a preliminary face-to-face session to patients and caregivers TAU Weekly mindfulness sessions delivered on-line for patients and caregivers (a specific platform for on-line sessions will be used)

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Licia MI Grazzi, MD · Fondazione IRCCS Istituto Neurologico Carlo Besta

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05623254 on ClinicalTrials.gov