NCT06237530

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

26 days

First QC Date

December 4, 2023

Last Update Submit

January 30, 2024

Conditions

Keywords

body scaninteroceptioninteroceptivemindfulnesssomatosensory

Outcome Measures

Primary Outcomes (4)

  • Adherence assessed by completed intervention sessions

    Percentage of completed daily sessions during the 7-day intervention

    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

    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

    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.

    Immediately post-intervention

Secondary Outcomes (10)

  • Adaptive interoceptive sensibility style assessed by a questionnaire

    Immediately pre-intervention and immediately post-intervention

  • Sensitivity and attention to interoceptive signals assessed by a questionnaire

    Immediately pre-intervention and immediately post-intervention

  • Perceived Body Boundaries in bodily self-awareness assessed by a VAS

    Immediately pre-intervention and immediately post-intervention

  • Spatial Frame of Reference in bodily self-awareness assessed by a VAS

    Immediately pre-intervention and immediately post-intervention

  • Mindfulness trait assessed by a self-report questionnaire

    Immediately pre-intervention and immediately post-intervention

  • +5 more secondary outcomes

Study Arms (3)

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)

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).

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

Behavioral: External control meditation (ECM)

Interventions

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)

Also known as: Interoceptive body scan, Interoceptive meditation practice
Visceral Body Scan (VBS)

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).

Also known as: Exteroceptive body scan, Somatosensory meditation practice
Somatosensory body scan (SBS)

The ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment.

Also known as: Non-body meditation practice, Visual and auditory mindfulness exercise
External control meditation (ECM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology and Speech Therapy, University of Valencia

Valencia, Valencia, 46010, Spain

Location

Study Officials

  • Rosa M Baños, PhD

    Univeristy of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 4, 2023

First Posted

February 1, 2024

Study Start

July 26, 2023

Primary Completion

August 21, 2023

Study Completion

August 21, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations