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临床试验/NCT05899413
NCT05899413已完成不适用

Examining Transcutaneous Vagal Nerve Stimulation as a Facilitator of Social Bonding

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年2月17日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Self-reported Positive Affect

研究概览

简要总结

This study aims to understand the role of the vagus nerve in promoting social bonding by using a non-invasive stimulation technique called transcutaneous vagal nerve stimulation (tVNS). The investigators will investigate whether tVNS can improve emotional, physiological, and behavioral experiences during and after social interactions. Couples will be randomly assigned to receive either tVNS or a sham stimulation during gratitude expression and problem-solving discussions. The investigators will measure their subjective evaluations of the interactions and capture their physiological and behavioral synchrony. This research will shed light on the processes involved in social connection and explore the potential of tVNS as a tool to enhance bonding in close relationships.

详细描述

As fundamental as the need to belong is to human survival and functioning, decades of research have shown that social connection is critical to emotional well-being. The current investigation seeks to use the knowledge and technological advances in the biomedical field to examine the causal role of the vagus nerve in promoting social bonding. Specifically, building on the recent evidence suggesting the effects of transcutaneous vagal nerve stimulation (tVNS) on improving social cognitive functioning, this study will examine the utility of tVNS in modulating emotional, physiological, and behavioral experiences during and after social interactions. The investigators will examine if romantic couple assigned to receive tVNS vs. active sham stimulation during two types of conversations (i.e., gratitude expression and problem-solving discussion) show differences in their experiences of the interactions. The study outcomes will include subjective evaluations of the interaction (e.g., felt emotions) and their physiological synchrony. This investigation will provide insights into the mechanistic processes that undergird social connection and, importantly, be the first to examine the potential utility of tVNS as an intervention tool for promoting social bonding within close relationships.

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
Single (Participant)

盲法说明

Participant couples will be blinded to their condition. Experimenters running the study will not be blinded since tVNS administration currently requires their knowledge of the condition.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fluent in English
  • Having been in a relationship with the partner for at least a year
  • Within the age range of 18-39

排除标准

  • Major chronic disease. self-reported autoimmune disease; severe asthma; lung disease (such as chronic bronchitis; history of stroke, heart attack, epilepsy, brain injury); cardiovascular disease.
  • Cancer: if not in remission.
  • Substance dependence-current or long history (5 years of more).
  • Current psychiatric diagnosis that is not being treated with medication
  • Confounding medications, including those used to treat hypertension and cardiovascular conditions; psychoactive substances; and medications known to directly affect autonomic functioning.

结局指标

主要结局

Self-reported Positive Affect

时间窗: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes

During the conversation, overall, I felt… (1: not at all positive, 7: extremely positive)

Self-reported Negative Affect

时间窗: Once, self-reported in a survey immediately following conflict interaction, up to 10 minutes

During the conversation, overall, I felt… (1: not at all negative, 7: extremely negative)

Respiratory Sinus Arrhythmia

时间窗: Continuously throughout conflict conversation

RSA was assessed continuously throughout the conversation.

Interbeat Interval

时间窗: Continuously throughout the conflict conversation

IBI was assessed continuously throughout the conversation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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