- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768685
The Experience of Affective Touch in Obesity (AffTouch_OB)
August 20, 2025 updated by: Istituto Auxologico Italiano
The Experience of Affective Touch in Obesity: the Role of Social Anhedonia and Lifespan Experiences
The aim of the present research is to verify if the pleasantness of affective touch is comparable between women with obesity and healthy women, while measuring the level of social anhedonia and the lifespan experience of affective touch.
Study Overview
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
VCO
-
Piancavallo, VCO, Italy, 28824
- IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants with obesity will be consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy)
Description
Inclusion criteria:
- right-handed;
- diagnosis of obesity (i.e., the level of body mass index (BMI( greater than or equal to 30).
Exclusion Criteria:
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
- Evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Controls
Age-matched, right-handed, healthy women (i.e., with no history of eating disorders) will be recruited outside the hospital through personal contacts of the researchers and word-of-mouth.
|
Affective touch paradigm: experimental stimuli will include the touch of a soft cosmetic, a hand, which will be both expected to resemble affective pleasant stimulations, and a plastic stick with a rounded tip, as a control (non-affective) condition.
Two speeds of stimulation will be adopted i) slow affective stimuli delivered at 3 cm/s and fast non-affective stimuli, delivered at non-optimal speed (18 cm/s).
An imagery version of the task will be also administered: blindfolded participants will be asked to image the touches on their left forearm.
After each (actual or imagined) tactile stimulus, individuals will rate the experience level of pleasantness.
As part of the protocol, they will fill out two psychological questionnaires, assessing the level of social anhedonia and the amount and characteristics of the lifespan experiences of affective touch inclose relationships.
|
|
Cases
Right-handed women diagnosed with obesity will be consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders will be exclusion criteria, as well as the evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars)
|
Affective touch paradigm: experimental stimuli will include the touch of a soft cosmetic, a hand, which will be both expected to resemble affective pleasant stimulations, and a plastic stick with a rounded tip, as a control (non-affective) condition.
Two speeds of stimulation will be adopted i) slow affective stimuli delivered at 3 cm/s and fast non-affective stimuli, delivered at non-optimal speed (18 cm/s).
An imagery version of the task will be also administered: blindfolded participants will be asked to image the touches on their left forearm.
After each (actual or imagined) tactile stimulus, individuals will rate the experience level of pleasantness.
As part of the protocol, they will fill out two psychological questionnaires, assessing the level of social anhedonia and the amount and characteristics of the lifespan experiences of affective touch inclose relationships.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rating of subjective pleasantness
Time Frame: baseline
|
Behavioural outcome associated with the experimental paradigm: participants will be asked to rate the pleasantness of the tactile stimuli after each stimulation with a score ranging from zero not pleasant at all) to 100 (extremely pleasant).
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social anhedonia score
Time Frame: baseline
|
Social anhedonia will be evaluated with the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS, Gooding and Pflum, 2014); this is a 17-item self-report measure of individuals' tendency to look forward to interactions with others (anticipatory interpersonal pleasure - 7 items) and experienced pleasure in social interactions (consummatory interpersonal pleasure - 10 items).
The ACIPS is scored on a Likert scale ranging from 1 (very false for me) to 6 (very true for me); higher scores indicate higher anticipatory and consummatory interpersonal pleasure.
|
baseline
|
|
Affective experience score
Time Frame: baseline
|
The lifespan experience of affective touch in close relationships will be assessed with the Tactile Biography questionnaire (TBIO, Beltrán et al., 2020).
This includes a 29-item self-report measure scored on a Likert scale ranging from 1 (e.g., not at all true for me) to 5 (e.g., extremely true) that evaluate four independent components: the frequency of and satisfaction for affective touch i) in childhood/adolescence and ii) adulthood, iii) comfort with and iv) fondness for interpersonal touch in close relationships
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2021
Primary Completion (Actual)
October 1, 2024
Study Completion (Actual)
October 1, 2024
Study Registration Dates
First Submitted
February 22, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 14, 2023
Study Record Updates
Last Update Posted (Estimated)
August 26, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21C128
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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