The Effects of Oxytocin Treatment on Social Touch

May 10, 2023 updated by: Keith Kendrick, University of Electronic Science and Technology of China

The Effects of Oxytocin on Social Touch: an fNIRS-based Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

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

    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • University of Electronic Science and Technology of China(UESTC)

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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal oxytocin
Participants will be randomly assigned to the administration of oxytocin intranasal spray (24 IU).
Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).
Other Names:
  • Oxytocin intranasal spray
Experimental: Oral oxytocin
Participants will be randomly assigned to the administration of oxytocin lingual spray (24 IU).
Each subject will be assigned to administration of oxytocin lingual spray (24 IU).
Other Names:
  • Oxytocin lingual spray
Placebo Comparator: Placebo
Participants will be randomly assigned to the administration of placebo.
An identical amount of intranasal administration of placebo (identical ingredients except the peptide - i.e. glycerine and sodium chloride) will be assigned to each subject.
Other Names:
  • PLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural index: fNIRS based measures of touch processing
Time Frame: 35-90 minutes after treatment administration
fNIRS-based indices of neural processing of social touch after the oxytocin and placebo administration in response to each experimental condition.
35-90 minutes after treatment administration
Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch
Time Frame: 50-90 minutes after treatment administration
Ratings of perceived pleasantness, arousal, intensity and the willing to pay for the applied caress-like touch and massage after the oxytocin and placebo administration.
50-90 minutes after treatment administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma oxytocin concentration
Time Frame: Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
Basal and altered blood oxytocin concentrations for different treatment groups before and 30 minutes after the administration as well as after each touch condition.
Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
Electrophysiological index: skin conductance responses (SCR)
Time Frame: 35-90 minutes after treatment administration
SCR amplitudes during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.
35-90 minutes after treatment administration
Electrophysiological index: heart rate variability (HRV)
Time Frame: 35-90 minutes after treatment administration
HRV reflecting the variability in consecutive heartbeats calculated from electrocardiography during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.
35-90 minutes after treatment administration
Questionnaire scores of autistic traits
Time Frame: Before the experiment
The Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) to investigate modulatory effects of autistic traits.
Before the experiment
Gender difference in the neural and behavioral index
Time Frame: 35-90 minutes after treatment administration
Gender difference in the neural and behavioral response during the touch processing for different treatment groups.
35-90 minutes after treatment administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Qin Li, Dr., University of Electronic Science and Technology of China

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)

September 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • UESTC-neuSCAN-79

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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