The Effects of Body Scan on Enteroception in Patients With Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentro Cardiologico Monzino
About this trial
The study aims to explore the effects of body scan on enteroception in people with heart failure
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Heart Failure
Italian speaking
Willing to sign the Informed Consent Form
Disqualifiers
Cognitive Impairment documented in the medical records
Trial design
Design model
Parallel
Treatments tested in this trial
Body Scan
BehavioralBody 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Enteroceptive 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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centro Cardiologico Monzino
Lead sponsor
University of Rome Tor Vergata
Collaborator
Bicocca Universiy of Milano, Milan, Italy
Collaborator
American Holistic Nurses Association (AHNA)
Collaborator
Source ClinicalTrials.gov