HealthyPhase 1/2NCT06237530
Interoception and Body Scan
A Phase 1/2 study testing Visceral body scan (VBS) and Somatosensory body scan (SBS) in people with Healthy, run by University of Valencia at 1 site in Spain.
Trial summary
Body scan meditation has been assumed to be an interoceptive intervention, and the evidence for its effects on interoceptive processes is unclear. Although this mindfulness based exercise typically involves focusing on some interoceptive signals such as breath, it also involves other bodily cues, such as somatosensory… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Visceral body scan (VBS) and Somatosensory body scan (SBS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jul 2023to 21 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18
- being Spanish or English speakers
- Ability to use a computer or smartphone
- Daily access to computer or smartphone with an Internet connection
Who cannot join
- Being diagnosed with a severe psychiatric disorder (e.g., substance abuse, eating disorder, psychotic disorder)
- Severe visual or auditory difficulties that cannot be corrected with glasses or auditory aids
- Having a medical condition that prevents participation in this study
- Changes in psychotropic medication during the study
- Having been exposed to any extremely traumatic event that is being re-experienced or interfering during the last month
- Body image-related difficulties as indicated by scores above 3 on the Body Image as Source of Shame questionnaire.
- Regular meditation practice in the current moment
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Psychology and Speech Therapy, University of Valencia
Valencia, Valencia, 46010
About this study
Official title: Exploring Visceral Body Scan, Somatosensory Body Scan, and External Meditation
Body scan meditation has been assumed to be an interoceptive intervention, and the evidence for its effects on interoceptive processes is unclear. Although this mindfulness based exercise typically involves focusing on some interoceptive signals such as breath, it also involves other bodily cues, such as somatosensory cues. The present study aimed to (1) investigate the feasibility of three online delivered mindfulness practices that differ in the signals targeted: visceral body scan (VBS), somatosensory body scan (SBS), and external (non body) meditation (ECM), and (2) gain insight into the potentially different effects of these interventions on interoceptive and other psychological outcomes in order to inform future full scale randomized controlled trials (RCT).
- Conditions
- Healthy
- Being tested
- Visceral body scan (VBS), Somatosensory body scan (SBS), External control meditation (ECM)
- Keywords
- body scan, interoception, interoceptive, mindfulness, somatosensory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral body scan (VBS)Behavioural
Also called Interoceptive body scan, Interoceptive meditation practice
The VBS consisted of a mindfulness exercise designed to bring awareness to visceral sensations in the cardiac, respiratory, gastrointestinal, and urinary systems. These physiological systems were chosen because most of the paradigms developed in the literature to assess interoception focus on them (Khalsa et al., and they are widely recognized in the literature as interoceptive senses (Nord \& Garfinkel, 2022)
Somatosensory body scan (SBS)Behavioural
Also called Exteroceptive body scan, Somatosensory meditation practice
The SBS consisted of a mindfulness exercise designed to bring awareness to tactile (e.g., itching) and musculoskeletal (e.g. g., tension) sensations in different parts of the body, namely, the head and neck, back, arms, and legs. Body scan exercises typically focus on these types of bodily cues (in addition to breathing) (Williams, 2010).
External control meditation (ECM)Behavioural
Also called Non-body meditation practice, Visual and auditory mindfulness exercise
The ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment.
| Study group | Role | What they receive |
|---|---|---|
| Visceral Body Scan (VBS) | Experimental | The VBS consisted of a mindfulness exercise designed to bring awareness to visceral sensations in the cardiac, respiratory, gastrointestinal, and urinary systems. These physiological systems were chosen because most of the paradigms developed in the literature to assess interoception focus on them (Khalsa et al., and they are widely recognized in the literature as interoceptive senses (Nord \& Garfinkel, 2022) Receives: Behavioral: Visceral body scan (VBS) |
| Somatosensory body scan (SBS) | Active comparator | The SBS consisted of a mindfulness exercise designed to bring awareness to tactile (e.g., itching) and musculoskeletal (e.g. g., tension) sensations in different parts of the body, namely, the head and neck, back, arms, and legs. Body scan exercises typically focus on these types of bodily cues (in addition to breathing) (Williams, 2010). Receives: Behavioral: Somatosensory body scan (SBS) |
| External control meditation (ECM) | Sham comparator | The ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment Receives: Behavioral: External control meditation (ECM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence assessed by completed intervention sessions
Percentage of completed daily sessions during the 7-day intervention
Measured: Through study completion, a total of 7 days
Meditation-related adverse effects assessed by a self-report questionnaire
Meditation-Related Adverse Effect Scale - Mindfulness-Based Program. It includes 11 dichotomic items (yes/no questions), so scores ranges from 0 to 11, with higher scores indicating more adverse effects
Measured: Immediately post-intervention
Acceptability assessed by a satisfaction questionnaire
Treatment Satisfaction Scale. It includes 5 items rated on Likert-point scale ranging from 0 to 10. Thus, total scores range from 0 to 50, with higher scores indicating greater acceptability of the intervention
Measured: Immediately post-intervention
Self-reported quality of the mindfulness practice
Practice Quality-Mindfulness. It consists of 6 items rated on a visual analogue scale ranging from 0 to 100, with higher scores reflecting a higher level of practice quality.
Measured: Immediately post-intervention
Secondary outcomes (10)
Adaptive interoceptive sensibility style assessed by a questionnaire
Multidimensional Assessment of Interoceptive Awareness-2. It consists of 37 items rated on a 6-point Likert scale, with higher values indicating a more adaptive and healthier interoceptive sensibility style (healthier approach to internal bodily signals).
Measured: Immediately pre-intervention and immediately post-intervention
Sensitivity and attention to interoceptive signals assessed by a questionnaire
Interoceptive Sensitivity and Attention Questionnaire. It consists of 17 items rated on a 5-point Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Higher scores reflect greater sensitivity to bodily sensations
Measured: Immediately pre-intervention and immediately post-intervention
Perceived Body Boundaries in bodily self-awareness assessed by a VAS
Perceived Body Boundaries Scale. It is visual analogue scale that depicts seven human bodies, ranging from almost imperceptible at the left pole (labeled "my body boundaries are almost imperceptible") to extremely salient at the right pole (labeled my body boundaries are extremely salient"). Scores can range from 0 to 15.5, with higher scores indicating greater salience in perceiving body boundaries.
Measured: Immediately pre-intervention and immediately post-intervention
Spatial Frame of Reference in bodily self-awareness assessed by a VAS
Spatial Frame of Reference Continuum. It is a visual analogue scale depicting five concentric circles surrounding the outline of a human figure, and individuals are asked to indicate how far they feel that their self extends beyond their physical body. Scores range from 1 to 6, with higher scores reflecting a more allocentric (vs. egocentric) frame of reference.
Measured: Immediately pre-intervention and immediately post-intervention
Mindfulness trait assessed by a self-report questionnaire
Short form of the Five Facet Mindfulness Questionnaire. It is a 15-item instrument that measures the tendency to be mindful in daily life. Items are rated on a 5-point Likert scale, from 1 (never or very rarely true) to 5 (very often or always true). It includes the following dimensions: observing, describing, acting with awareness, non judging internal experience, and non reactivity to internal experience. Higher scores indicate higher levels of the corresponding mindfulness dimension.
Measured: Immediately pre-intervention and immediately post-intervention
Alexithymia assessed by a self-report questionnaire
The Perth Alexithymia Questionnaire Questionnaire-Short Form. It includes 7 items rated on a 7-point Likert scale (1=strongly disagree; 7=strongly agree), with higher scores indicating higher levels of alexithymia
Measured: Immediately pre-intervention and immediately post-intervention
Negative emotion regulation assessed by a self-report questionnaire
Short-form version of the Difficulties in Emotion Regulation Scale. It is an 18 item questionnaire that measures the degree of difficulty in regulating emotions. Items are rated on a 5 point Likert scale, ranging from 1 (almost never) to 5 almost always). It includes the following dimensions: (1) lack of emotional awareness of one's own emotions; (2) self reported difficulty in completing tasks and concentrating in the presence of negative emotions; (3) limited access to regulatory strategies that the in dividual perceives as effective; (4) nonacceptance of negative emotional states; (5) self reported difficulty in controlling one's behavior in the presence of negative emotional states, and (6) lack of emotional clarity, i.e., limited knowledge and clarity about one's emotional states. Higher scores indicate higher difficulties in regulating emotions.
Measured: Immediately pre-intervention and immediately post-intervention
Positive emotion regulation assessed by a self-report questionnaire
Responses to Positive Affect Questionnaire. It is a 16 item questionnaire that measures responses to positive moods, including dampening (i.e., thoughts that are likely to dampen positive emotional states), self focused positive rumination (i.e., rumination on aspects of the self and the pursuit of goals relevant to the self), and emotion focused positive rumination (i.e., rumination on positive mood). Items are rated on a 4 point Likert scale, ranging from 1 almost never ) to 4 almost always ), with higher scores reflecting a greater use of such strategy.
Measured: Immediately pre-intervention and immediately post-intervention
Depressive symptomatology assessed by a self-report questionnaire
Patient Health Questionnaire-9. It consists of 9 items, which are rated on a 4-point Likert scale, ranging from 0 (never) to 4 (almost every day). Higher scores indicate greater severity of depressive symptoms.
Measured: Immediately pre-intervention and immediately post-intervention
Qualitative feedback assessed by several open-ended questions
Ad-hoc open-ended questions: ended questions: (1) "Do you think that participating in this study has helped you learn something or become aware of something? If so, what did you learn?"; (2) Do you think that doing the meditation practice has helped you improve anything? If so, what benefits have you noticed noticed?"; (3) Does this practice make sense to you, and why? "; (4) Please describe the sensations, thoughts and/or feelings you have had while doing the meditation practice "; (5) What difficulties have you found when doing the meditation practice?"; (6) What did you like most about the meditation practice? And what did you like the least?", and (7) What do you think is the objective or hypothesis of the study?".
Measured: Immediately pre-intervention and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start26 Jul 2023
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators tested two different versions of the body scan (meditation practice), one focused on visceral signals -visceral body scan (VBS)- and the other on somatosensory signals -somatosensory body scan (SBS)- in comparison to an exteroceptive, non-body focused, control condition -external control meditation (ECM)-. To do so, an online approach was conducted, as it has been proved to be an effective strategy, while being more widely accessible and reducing costs and time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa M. Baños Rivera, University of Valencia
- Investigators
- Rosa M Baños, PhD, Principal investigator, Univeristy of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237530
- Sponsor's protocol ID
- 2569173
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Visceral Body Scan, Somatosensory Body Scan, and External Meditation
- ClinicalTrials.gov ID
- NCT06237530
- Acronym / sponsor ID
- 2569173
- Conditions
- Healthy
- Keywords
- body scan, interoception, interoceptive, mindfulness, somatosensory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 1 Feb 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.
Body scan meditation has been assumed to be an interoceptive intervention, and the evidence for its effects on interoceptive processes is unclear. Although this mindfulness based exercise typically involves focusing on some interoceptive signals such as breath, it also involves other bodily cues, such as somatosensory cues. The present study aimed to (1) investigate the feasibility of three online delivered mindfulness practices that differ in the signals targeted: visceral body scan (VBS), somatosensory body scan (SBS), and external (non body) meditation (ECM), and (2) gain insight into the potentially different effects of these interventions on interoceptive and other psychological outcomes in order to inform future full scale randomized controlled trials (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The investigators tested two different versions of the body scan (meditation practice), one focused on visceral signals -visceral body scan (VBS)- and the other on somatosensory signals -somatosensory body scan (SBS)- in comparison to an exteroceptive, non-body focused, control condition -external control meditation (ECM)-. To do so, an online approach was conducted, as it has been proved to be an effective strategy, while being more widely accessible and reducing costs and time.
| Arm | Type | Receives |
|---|---|---|
| Visceral Body Scan (VBS) | Experimental | Behavioral: Visceral body scan (VBS)The VBS consisted of a mindfulness exercise designed to bring awareness to visceral sensations in the cardiac, respiratory, gastrointestinal, and urinary systems. These physiological systems were chosen because most of the paradigms developed in the literature to assess interoception focus on them (Khalsa et al., and they are widely recognized in the literature as interoceptive senses (Nord \& Garfinkel, 2022) |
| Somatosensory body scan (SBS) | Active comparator | Behavioral: Somatosensory body scan (SBS)The SBS consisted of a mindfulness exercise designed to bring awareness to tactile (e.g., itching) and musculoskeletal (e.g. g., tension) sensations in different parts of the body, namely, the head and neck, back, arms, and legs. Body scan exercises typically focus on these types of bodily cues (in addition to breathing) (Williams, 2010). |
| External control meditation (ECM) | Sham comparator | Behavioral: External control meditation (ECM)The ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- being Spanish or English speakers
- Ability to use a computer or smartphone
- Daily access to computer or smartphone with an Internet connection
Key exclusion criteria (7 listed)
- Being diagnosed with a severe psychiatric disorder (e.g., substance abuse, eating disorder, psychotic disorder)
- Severe visual or auditory difficulties that cannot be corrected with glasses or auditory aids
- Having a medical condition that prevents participation in this study
- Changes in psychotropic medication during the study
- Having been exposed to any extremely traumatic event that is being re-experienced or interfering during the last month
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 |
|---|---|---|
| Visceral body scan (VBS)Also: Interoceptive body scan, Interoceptive meditation practiceThe VBS consisted of a mindfulness exercise designed to bring awareness to visceral sensations in the cardiac, respiratory, gastrointestinal, and urinary systems. These physiological systems were chosen because most of the paradigms developed in the literature to assess interoception focus on them (Khalsa et al., and they are widely recognized in the literature as interoceptive senses (Nord \& Garfinkel, 2022) | Behavioural | Visceral Body Scan (VBS) |
| Somatosensory body scan (SBS)Also: Exteroceptive body scan, Somatosensory meditation practiceThe SBS consisted of a mindfulness exercise designed to bring awareness to tactile (e.g., itching) and musculoskeletal (e.g. g., tension) sensations in different parts of the body, namely, the head and neck, back, arms, and legs. Body scan exercises typically focus on these types of bodily cues (in addition to breathing) (Williams, 2010). | Behavioural | Somatosensory body scan (SBS) |
| External control meditation (ECM)Also: Non-body meditation practice, Visual and auditory mindfulness exerciseThe ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment. | Behavioural | External control meditation (ECM) |
Primary outcome
Adherence assessed by completed intervention sessions
Time frame: Through study completion, a total of 7 days
Percentage of completed daily sessions during the 7-day intervention
Meditation-related adverse effects assessed by a self-report questionnaire
Time frame: Immediately post-intervention
Meditation-Related Adverse Effect Scale - Mindfulness-Based Program. It includes 11 dichotomic items (yes/no questions), so scores ranges from 0 to 11, with higher scores indicating more adverse effects
Acceptability assessed by a satisfaction questionnaire
Time frame: Immediately post-intervention
Treatment Satisfaction Scale. It includes 5 items rated on Likert-point scale ranging from 0 to 10. Thus, total scores range from 0 to 50, with higher scores indicating greater acceptability of the intervention
Self-reported quality of the mindfulness practice
Time frame: Immediately post-intervention
Practice Quality-Mindfulness. It consists of 6 items rated on a visual analogue scale ranging from 0 to 100, with higher scores reflecting a higher level of practice quality.
10 secondary outcomes
Adaptive interoceptive sensibility style assessed by a questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Sensitivity and attention to interoceptive signals assessed by a questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Perceived Body Boundaries in bodily self-awareness assessed by a VAS
Time frame: Immediately pre-intervention and immediately post-intervention
Spatial Frame of Reference in bodily self-awareness assessed by a VAS
Time frame: Immediately pre-intervention and immediately post-intervention
Mindfulness trait assessed by a self-report questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Alexithymia assessed by a self-report questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Negative emotion regulation assessed by a self-report questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Positive emotion regulation assessed by a self-report questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Depressive symptomatology assessed by a self-report questionnaire
Time frame: Immediately pre-intervention and immediately post-intervention
Qualitative feedback assessed by several open-ended questions
Time frame: Immediately pre-intervention and immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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. This study is not recruiting at the moment.
Rosa M Baños, PhD principal investigator
Univeristy of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Visceral body scan (VBS) and Somatosensory body scan (SBS) in people with Healthy, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence assessed by completed intervention sessions (time frame: Through study completion, a total of 7 days). The study lists 4 primary outcomes in all. 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 1 Feb 2024.