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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05756530
Other study ID # 21C127
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 6, 2021
Est. completion date October 1, 2023

Study information

Verified date February 2023
Source Istituto Auxologico Italiano
Contact Federica Scarpina, PHD
Phone +29032351
Email f.scarpina@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the present research will be to verify if the pleasantness of affective touch is comparable between women with AN and healthy women while measuring the level of social anhedonia and the lifespan experience of affective touch.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion criteria: - Right-handed - diagnosis of restricting type or binge-eating/purging type AN, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)'s criteria (DSM, American Psychiatric Association, 2013). 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Affective touch paradigm
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 in close relationships.

Locations

Country Name City State
Italy IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe Piancavallo VCO

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rating of subjective pleasantness 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 Social Anhedonia Score 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.the assessment Baseline
Secondary Affective experience Score 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. However, the experience of affective touch in adulthood was not included in the analyses since most of our participants did not have long experience in adult relationships since their age. Three additional items allow the recording of the feelings experienced in bodily affective interactions, the presence of negative/unpleasant experiences involving interpersonal touch and the preference for giving and/or receiving affective touch.affective touch in close relationships. Baseline
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