The study aims to explore the effects of body scan on enteroception in people with heart failure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
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.
Cardiology Center Monzino IRCCS
Milan, Italy, Italy
RECRUITINGIRCCS Cardiology Center Monzino
Milan, Italy
NOT_YET_RECRUITINGEnteroceptive sensibility
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.
Time frame: At 1 month after the end of the body scan intervention
Enteroceptive Sensibility
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
Time frame: At 3, 6, and 9 month after the end of the intervention
Enteroceptive Accuracy
Enteroceptive Accuracy (assessed with the Heartbeat Tracking Task)
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Enteroceptive Awareness
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
Time frame: At baseline, after 1, 3, 6, and 9 months after the end of the intervention
Symptoms Perception
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.
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Generic Quality of Life
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').
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Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Heart Failure Specific Quality of Life
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.
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Self-care
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
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Self-care Self-efficacy
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.
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Anxiety
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
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Depression
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
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Alexithymia
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.
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Emotional Regulation
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
Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention