Heart FailureSCAN-HFNCT06737679
The Effects of Body Scan on Enteroception in Patients With Heart Failure
A study testing Body Scan in people with Heart Failure, run by Centro Cardiologico Monzino at 2 sites in Italy.
Trial summary
The study aims to explore the effects of body scan on enteroception in people with heart failure Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Body Scan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesItaly
- Study dates
- 28 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Heart Failure
- Italian speaking
- Willing to sign the Informed Consent Form
Who cannot join
- Cognitive Impairment documented in the medical records
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Cardiology Center Monzino IRCCS
Milan, Italy, 20138
Alessia Martina Trenta, Dr, 00390258002445, alessia.trenta@cardiologicomonzino.it
Alessia Martina Trenta, Dr
- Not yet recruiting
IRCCS Cardiology Center Monzino
Milan, 20138
About this study
Official title: 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
- Conditions
- Heart Failure
- Being tested
- Body Scan
- Keywords
- Heart failure, Enteroception, Body scan, Mindfullness, Self-care monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body ScanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Body Scan |
| Control group | No intervention | The control group will not receive the intervention, but only standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 month after the end of the body scan intervention
Secondary outcomes (12)
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
Measured: At 3, 6, and 9 month after the end of the intervention
Enteroceptive Accuracy
Enteroceptive Accuracy (assessed with the Heartbeat Tracking Task)
Measured: 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
Measured: 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.
Measured: 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').
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: At baseline, 1, 3, 6, and 9 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start28 Jan 2025
- Primary completion7 Mar 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata, Bicocca Universiy of Milano, Milan, Italy, American Holistic Nurses Association (AHNA)
- Responsible party
- Principal investigator, Alessia Trenta, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737679
- Sponsor's protocol ID
- R1940/24-L2-156
- Acronym
- SCAN-HF
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Body Scan on Enteroception in Patients With Heart Failure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06737679
- Acronym / sponsor ID
- SCAN-HF / R1940/24-L2-156
- Conditions
- Heart Failure
- Keywords
- Heart failure, Enteroception, Body scan, Mindfullness, Self-care monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata, Bicocca Universiy of Milano, Milan, Italy, American Holistic Nurses Association (AHNA)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore the effects of body scan on enteroception in people with heart failure
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Body ScanThe 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. |
| Control group | No intervention | –The control group will not receive the intervention, but only standard care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Heart Failure
- Italian speaking
- Willing to sign the Informed Consent Form
Key exclusion criteria (1 listed)
- Cognitive Impairment documented in the medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body ScanBody 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. | Behavioural | Experimental group |
Primary outcome
Enteroceptive sensibility
Time frame: At 1 month after the end of the body scan intervention
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Scan in people with Heart Failure, run by Centro Cardiologico Monzino at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessia M Trenta, Dr (00390258002445, alessia.trenta@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteroceptive sensibility (time frame: At 1 month after the end of the body scan intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.