The Effects of Body Scan on Enteroception in Patients with Heart Failure (SCAN-HF)

The Effects of Body Scan on Enteroception in Patients with Heart Failure: a Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Body Scan

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessia M Trenta, Dr; Phone Number: 00390258002445; Email: alessia.trenta@cardiologicomonzino.it

Study Locations

• Italy
  • Milan, Italy, 20138
    • Recruiting
    • Cardiology Center Monzino IRCCS
    • Contact: Alessia Martina Trenta, Dr; Phone Number: 00390258002445; Email: alessia.trenta@cardiologicomonzino.it
    • Contact: Alessia Martina Trenta, Dr
  • Milan, Italy, 20138
    • Not yet recruiting
    • IRCCS Cardiology Center Monzino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Cognitive Impairment documented in the medical records

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; 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.
No Intervention: Control group; The control group will not receive the intervention, but only standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 3, 6, and 9 month after the end of the intervention
Enteroceptive Accuracy	Enteroceptive Accuracy (assessed with the Heartbeat Tracking Task)	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	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.	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').	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	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.	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	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	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.	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	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.	At baseline, 1, 3, 6, and 9 months after the end of the intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): March 7, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; Mindfullness; Enteroception; Body scan; Self-care monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: R1940/24-L2-156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No