Recruiting NCT06737679
The Effects of Body Scan on Enteroception in Patients With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Body Scan.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Body Scan on Enteroception in Patients With Heart Failure: a Randomized Controlled Trial
Overview
The study aims to explore the effects of body scan on enteroception in people with heart failure
Interventions
- Behavioral Body 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.
Primary outcome measures
- Enteroceptive sensibility [Time frame: At 1 month after the end of the body scan intervention]
Secondary outcome measures (12)
- Enteroceptive Sensibility [Time frame: At 3, 6, and 9 month after the end of the intervention]
- Enteroceptive Accuracy [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Enteroceptive Awareness [Time frame: At baseline, after 1, 3, 6, and 9 months after the end of the intervention]
- Symptoms Perception [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Generic Quality of Life [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Heart Failure Specific Quality of Life [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Self-care [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Self-care Self-efficacy [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Anxiety [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Depression [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Alexithymia [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
- Emotional Regulation [Time frame: At baseline, 1, 3, 6, and 9 months after the end of the intervention]
Eligibility criteria
Inclusion criteria
- Diagnosed with Heart Failure
- Italian speaking
- Willing to sign the Informed Consent Form
Exclusion criteria
- Cognitive Impairment documented in the medical records
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 2 centers
- Cardiology Center Monzino IRCCS — Milan
- IRCCS Cardiology Center Monzino — Milan
Identifiers
NCT: NCT06737679 · R1940/24-L2-156