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NCT Number: NCT06737679

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Center Monzino IRCCS, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cognitive Impairment documented in the medical records

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Enteroceptive Sensibility

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

    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

  2. Enteroceptive Accuracy

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

    Enteroceptive Accuracy (assessed with the Heartbeat Tracking Task)

  3. Enteroceptive Awareness

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

    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

  4. Symptoms Perception

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

    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.

  5. Generic Quality of Life

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

    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').

  6. Heart Failure Specific 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 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.

  7. Self-care

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

    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

  8. Self-care Self-efficacy

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

    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.

  9. Anxiety

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

    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

  10. Depression

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

    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

  11. Alexithymia

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

    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.

  12. Emotional Regulation

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia M Trenta, Dr

CONTACT

[email protected]

00390258002445

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

  • American Holistic Nurses Association (AHNA)
  • Bicocca Universiy of Milano, Milan, Italy
  • University of Rome Tor Vergata

Registry information

Official study title

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

Acronym: SCAN-HF

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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