Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899517
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-05-05
Brief Title:
Oxytocin Effects on Self Versus Other Touch
Sponsor:
University of Electronic Science and Technology of China
Organization:
University of Electronic Science and Technology of China
Study Overview
Official Title:
The Effects of Orally Administered Oxytocin on Behavioral and Neural Responses to Self Versus Other Touch Distinction
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim of the study is to investigate the modulatory effects of oxytocin 24IU administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others
Detailed Description:
In a double-blind placebo-controlled within-subject experimental design 40 adult male subjects will be randomly allocated to either receive oral oxytocin 24IU medicated lollipop or placebo lollipop without oxytocin Starting 45 minutes after treatment a resting state functional magnetic resonance imaging fMRI will be recorded 8min and next subjects will be applied two different types of stroking touch self- vs other-produced touch to their left arm repeated in 16 blocks After each block of applied touch stimulation subjects will be required to rate their perceived pleasantness of touch from -4 extremely unpleasant to 4 extremely pleasant The neural basis of touch processing will be measured via simultaneously acquired fMRI
To control potential confounding effects among subjects before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality traits attitude towards interpersonal touch and interoceptive ability Autism Spectrum Quotient ASQ Beck Depression Inventory II BDI State-Trait Anxiety Inventory STAI Social Touch Questionnaire STQSensory Over-Responsivity SensOR Scales Interpersonal Reactivity Index C-IRI Self-Concept Clarity Scale SCCS Interoceptive Confusion QuestionnaireICQ and Multidimensional Assessment of Interoceptive AwarenessMAIA scale Additionally to control for potential confounding effects of treatment on mood across the experiment the Positive and Negative Affect Schedule PANAS will be administered immediately before and 30 minutes after the treatment Participants will also complete the PANAS after the touch stimulations to further measure the modulatory effects of touch on mood
To control potential confounding effects among subjects before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality traits attitude towards interpersonal touch and interoceptive ability Autism Spectrum Quotient ASQ Beck Depression Inventory II BDI State-Trait Anxiety Inventory STAI Social Touch Questionnaire STQSensory Over-Responsivity SensOR Scales Interpersonal Reactivity Index C-IRI Self-Concept Clarity Scale SCCS Interoceptive Confusion QuestionnaireICQ and Multidimensional Assessment of Interoceptive AwarenessMAIA scale Additionally to control for potential confounding effects of treatment on mood across the experiment the Positive and Negative Affect Schedule PANAS will be administered immediately before and 30 minutes after the treatment Participants will also complete the PANAS after the touch stimulations to further measure the modulatory effects of touch on mood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None