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临床试验/NCT05265806
NCT05265806已完成不适用

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

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Neural index: fNIRS based measures of touch processing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Intranasal oxytocin

Experimental

Participants will be randomly assigned to the administration of oxytocin intranasal spray (24 IU).

干预措施: Intranasal oxytocin (Drug)

Oral oxytocin

Experimental

Participants will be randomly assigned to the administration of oxytocin lingual spray (24 IU).

干预措施: Oral oxytocin (Drug)

Placebo

Placebo Comparator

Participants will be randomly assigned to the administration of placebo.

干预措施: Placebo (Drug)

结局指标

主要结局

Neural index: fNIRS based measures of touch processing

时间窗: 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.

Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch

时间窗: 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.

次要结局

  • Gender difference in the neural and behavioral index(35-90 minutes after treatment administration)
  • Questionnaire scores of autistic traits(Before the experiment)
  • Plasma oxytocin concentration(Basal concentration before treatment and altered level during 30-90 minutes after treatment administration)
  • Electrophysiological index: skin conductance responses (SCR)(35-90 minutes after treatment administration)
  • Electrophysiological index: heart rate variability (HRV)(35-90 minutes after treatment administration)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Keith Kendrick

: Professor

University of Electronic Science and Technology of China

研究点 (1)

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