Heart Failure
Conditions
Keywords
Heart failure, Enteroception, Body scan, Mindfullness, Self-care monitoring
Brief summary
The study aims to explore the effects of body scan on enteroception in people with heart failure
Interventions
BEHAVIORALBody Scan
Body scan is a guided meditation technique that allows people to detect signs and signals from their body (for instance, heart rate). The intervention will last 20 minutes and will be performed 21 consecutives days. The first and last days it will be performed in presence, while the other ones online.
Sponsors
University of Rome Tor Vergata
Bicocca Universiy of Milano, Milan, Italy
American Holistic Nurses Association (AHNA)
Centro Cardiologico Monzino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Heart Failure * Italian speaking * Willing to sign the Informed Consent Form
Exclusion criteria
* Cognitive Impairment documented in the medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enteroceptive sensibility | At 1 month after the end of the body scan intervention | Enteroceptive Sensibility (assessed with the Multidimensional Assessment of Interoceptive Awareness, version 2, MAIA-2) The MAIA-2 is a 6-point Likert scale questionnaire with 37 items divided into 8 subscales. Higher scores reflect greater enteroceptive sensibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enteroceptive Accuracy | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Enteroceptive Accuracy (assessed with the Heartbeat Tracking Task) |
| Enteroceptive Awareness | At baseline, after 1, 3, 6, and 9 months after the end of the intervention | Enteroceptive Awareness will be calculated with Pearson's r confidence, using the HTT score as a measure of interoceptive accuracy and a confidence VAS (0-10) as a partial measure of interoceptive sensibility |
| Symptoms Perception | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Symptom Perception (assessed with the Heart Failure Somatic Perception Scale), which is a 6-point Likert scale with 18 items. Higher scores reflect a higher impact of heart failure on patients' lives. |
| Generic Quality of Life | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Quality of Life wil be assessed with the 5-dimensions version of EuroQoL (EQ-5D). The EuroQoL is a standardized measure of health status divided into two sections: section one comprises 5 dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) and 3 levels (no problems, some problems, extreme problems); section two asks participants to rank their perceived health status with a VAS ranging from 0 ('The worst health you can imagine') to 100 ('The best health you can imagine'). |
| Heart Failure Specific Quality of Life | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Heart Failure Specific Quality of Life will be measured using the 12-Items Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ comprises 12 items exploring 4 dimensions. Scores range from 0 to 100, where 100 reflects a higher functioning level. |
| Enteroceptive Sensibility | At 3, 6, and 9 month after the end of the intervention | Enteroceptive Sensibility (assessed with Multidimensional Assessment of Interoceptive Awareness, version 2, MAIA-2) MAIA-2 is a 6-point Likert scale questionnaire with 37 items divided into 8 subscales. Higher scores reflect greater interoception |
| Self-care Self-efficacy | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Self-care Self-efficacy will be assessed using the Self-Care Self-Efficacy Scale, which comprises 10 items, answerable from a 1 to 5 option-scale. Scores are standardized to range from 0 to 100, with higher scores representing higher levels of self-efficacy. |
| Anxiety | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Anxiety (assessed with the State-Trait Anxiety Inventory Form Y, STAI-Y) The State-Trait Anxiety Inventory Form Y (STAI-Y) is a validated questionnaire divided into two scales measuring state and trait anxiety, respectively. Both STAI-S and STAI-T comprise 20 items each, for a total of 40 items. Items are rated on a 4-point scale, with higher scores reflecting greater anxiety levels |
| Depression | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Depression will be measured with the Beck Depression Inventory-II (BD-II). It has 21 items, answerable on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate greater severity of depression symptoms |
| Alexithymia | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Alexithymia will be assessed using the 20-item Toronto Alexithymia Scale (TAS-20). It comprises 3 factors, answerable with a 5-point Likert scale, with increasing scores indicating higher degrees of alexithymia. |
| Emotional Regulation | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Emotional Regulation will be assessed with the Emotional Regulation Questionnaire (ERQ). ERQ is a 10-item self-report questionnaire, rated on a 7-point Likert scale from 1 ('Strongly Disagree') to 7 ('Strongly Agree'), with higher scores indicating higher emotional regulation |
| Self-care | At baseline, 1, 3, 6, and 9 months after the end of the intervention | Self-care will be assessed with the Self-Care of Heart Failure Index version 7.2. It is a 29-item instrument exploring three dimensions with 5-point Likert-type options. Higher scores reflect better self-care |
Countries
Italy
Contacts
Primary ContactAlessia M Trenta, Dr
Outcome results
None listed