Trials / Completed
CompletedNCT05247411
Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients
Nurse Educational Intervention Improves Symptoms Control and Compliance in Fibromyalgia Patients on Medical Cannabis Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Milano Bicocca · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To improve self-care and therapy adherence by fibromyalgia (FM) patients through a nursing educational intervention. Historic diagnoses of subjects included terms such as "insane", "imaginary ill", "whiny"; as well, their physical conditions were underestimated by their immediate families. All subjects have problematic employment histories which consistently identified their varied employments as physically too demanding. Over time, increased physician- and societal-awareness, resulted in all subjects being diagnosed with FM; consequently, all subjects reported a strong desire to become well-informed about FM and its treatment. Although medical cannabis (MC) was an available therapy, twenty subjects reported that cannabis had never been proposed despite years of ineffective therapies. In this tudy the effects of a educational intervention by expert nurses on fibromyalgia and MC use were investigated.
Detailed description
Aims This study aims to evaluate the knowledge of fibromyalgia patients who use therapeutic cannabis or are interested in taking it, introducing the figure of the nurse in the therapeutic path of patients. The primary objective was to increase the knowledge relating to FM (in terms of symptoms, onset, treatment strategies that can improve the quality of life), self-care and adherence through a nursing educational intervention. The secondary objective was to evaluate the efficacy of the nursing educational intervention, using validated clinimetric scales. Design We performed a qualitative study with face-to-face semi-structured interviews and patient tailored educational interventions. Two weeks before the interview, subjects were asked to complete the Fibromyalgia Impact Questionnaire Revised (FIQR) and the A-14 Scale online. Two weeks after the interview, patients were asked to complete the same questionnaires in addition the Clinical Global Impression - Global Improvement (CGI-I) Scale. This study adheres to the Consolidated criteria for Reporting Qualitative research (COREQ). Data collection After obtaining written informed consent for participation in the study, each participant was asked to complete online the Fibromyalgia Impact Questionnaire Revised (FIQR) and The A-14 Scale. Two weeks after completing these online questionnaires, a Skype-videoconference, which included a 30 min educational intervention, was held with each subject. Two weeks after the videoconference, patients were required to complete the FIQR, The A-14 Scale, as well as the Clinical Global Impression - Global Improvement (CGI-I) Scale Data analysis Descriptive analyses were performed on study participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Educational intervention | During the videoconference, the following items were investigated and evaluated: (i) Knowledge on FM: knowledge on symptoms, onset, treatment, strategies and non-pharmacological interventions that can be implemented to improve the quality of life (physical exercise, nutrition, participation in meditative movement practices, mutual aid groups, membership in a patient association, etc.); (ii) Any MC intake or interest in starting the intake of MC; (iii) Knowledge on MC therapy: specific knowledge on the drug, correct intake, adherence, treatment of side effects related to intake and strategies to reduce them; (iv) Self-care: how the person manages his personal life despite a chronic disease, how she or he monitors, recognizes and treats the symptoms in terms of timing and quality; possible presence of caregivers in their life who help in the management of the disease; employment and how FM affects it and daily life. |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2021-03-01
- Completion
- 2021-03-01
- First posted
- 2022-02-18
- Last updated
- 2022-02-18
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05247411. Inclusion in this directory is not an endorsement.