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Completed

NCT Number: NCT05265806

The Effects of Oxytocin Treatment on Social Touch

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, 611731, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intranasal oxytocin

Drug

Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).

Other names: Oxytocin intranasal spray

Oral oxytocin

Drug

Each subject will be assigned to administration of oxytocin lingual spray (24 IU).

Other names: Oxytocin lingual spray

Placebo

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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