The Effects of Body Scan on Enteroception in Patients With Heart Failure

NCT06737679 | Recruiting

• 1 other identifier: R1940/24-L2-156
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to explore the effects of body scan on enteroception in people with heart failure

Conditions

Heart Failure

Keywords

Heart failure; Enteroception; Body scan; Mindfullness; Self-care monitoring

Outcome Measures

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.

  At 1 month after the end of the body scan intervention

Secondary Outcomes (12)

• Enteroceptive Sensibility

  At 3, 6, and 9 month after the end of the intervention

• Enteroceptive Accuracy

  At baseline, 1, 3, 6, and 9 months after the end of the intervention

• Enteroceptive Awareness

  At baseline, after 1, 3, 6, and 9 months after the end of the intervention

• Symptoms Perception

  At baseline, 1, 3, 6, and 9 months after the end of the intervention

• Generic Quality of Life

  At baseline, 1, 3, 6, and 9 months after the end of the intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive a body scan intervention. 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.

Behavioral: Body Scan

Control group

NO INTERVENTION

The control group will not receive the intervention, but only standard care

Interventions

Body Scan BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Heart Failure
• Italian speaking
• Willing to sign the Informed Consent Form

You may not qualify if:

• Cognitive Impairment documented in the medical records

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• University of Rome Tor Vergata: collaborator
• Bicocca Universiy of Milano, Milan, Italy: collaborator
• American Holistic Nurses Association (AHNA): collaborator

Study Sites (2)

Cardiology Center Monzino IRCCS

Milan, Italy, 20138, Italy

RECRUITING

IRCCS Cardiology Center Monzino

Milan, 20138, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Whole Body Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Alessia M Trenta, Dr

CONTACT

00390258002445; alessia.trenta@cardiologicomonzino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: December 17, 2024
• Study Start: January 28, 2025
• Primary Completion: March 7, 2025
• Study Completion: January 31, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)