Clinical trial NCT05265806: The Effects of Oxytocin Treatment on Social Touch
Official title: The Effects of Oxytocin on Social Touch: an fNIRS-based Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Oxytocin
Social touch
fNIRS
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled double-blind mixed experimental design
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure.

Detailed description: A randomized double-blind placebo-controlled mixed experimental design with three arms (intranasal oxytocin administration vs. oral oxytocin administration vs. placebo administration, each with 60 subjects) will be employed in the current study. 35 minutes after treatment subjects will be applied two different types of pleasant touch (social massage vs. caress-like stroking) to their calf. After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment. The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording. Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing). Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.

To control potential confounding effects across groups, 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 sensitivity to reward: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), the Cheek and Buss Shyness Scale (CBSS), the Adult Attachment Scale (AAS), the Childhood Trauma Questionnaire (CTQ), social touch questionnaire (STQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Sensory Over-Responsivity (SensOR) Scales and the Interpersonal Reactivity Index (C-IRI). And associations between questionnaire scores (especially the ASQ and STQ scores) with primary outcome measure will be explored to investigate modulatory effects of autistic traits. 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 each type of touch condition to further measure the modulatory effects of stroking touch and massage on mood.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.

Exclusion Criteria:

* Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.

Primary outcomes:
measure: Neural index: fNIRS based measures of touch processing
timeFrame: 35-90 minutes after treatment administration
measure: Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch
timeFrame: 50-90 minutes after treatment administration
Secondary outcomes:
measure: Plasma oxytocin concentration
timeFrame: Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
measure: Electrophysiological index: skin conductance responses (SCR)
timeFrame: 35-90 minutes after treatment administration
measure: Electrophysiological index: heart rate variability (HRV)
timeFrame: 35-90 minutes after treatment administration
measure: Questionnaire scores of autistic traits
timeFrame: Before the experiment
measure: Gender difference in the neural and behavioral index
timeFrame: 35-90 minutes after treatment administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China(UESTC)
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Qin Li, Dr.
role: STUDY_CHAIR
References: