Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- NRS score
研究概览
简要总结
This study recruited healthy volunteers and randomly divided them into four groups. They inhaled oxytocin or saline, and watched a pain test video with photos of acquaintances or strangers, respectively, to test whether their feelings of the same thermal pain stimulus had changed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •During pregnancy;
- •Have participated in any research related to pain;
- •Sleep disorders;
- •Used alcohol, caffeine, nicotine, or other psychoactive substances within 24 hours before the test;
- •Experienced intense pain requiring medical analgesia within three months prior to the trial;
- •Taking any medication, including over the counter medication;
- •Addiction to alcohol, tobacco, or drugs;
- •A history of any respiratory, circulatory, neurological, musculoskeletal, and/or mental illness;
- •Current symptoms of depression and/or anxiety. (See quantitative sensor testing for specific standards)
研究组 & 干预措施
OS group
Half an hour after the volunteers inhaled 24 units of oxytocin spray, they watched the pre recorded video (attached with pictures and introductions of strangers) and underwent a pain test.
干预措施: Oxytocin nasal spray (Drug)
OS group
Half an hour after the volunteers inhaled 24 units of oxytocin spray, they watched the pre recorded video (attached with pictures and introductions of strangers) and underwent a pain test.
干预措施: Stranger (Behavioral)
PS group
Half an hour after the volunteers inhaled the same amount of saline spray, they watched the pre recorded video (with pictures and introductions of strangers attached) and received a pain test.
干预措施: Placebo (Drug)
PS group
Half an hour after the volunteers inhaled the same amount of saline spray, they watched the pre recorded video (with pictures and introductions of strangers attached) and received a pain test.
干预措施: Stranger (Behavioral)
OA group
Half an hour after the volunteers inhaled 24 units of oxytocin spray, they watched the pre recorded video (attached with pictures and introductions of acquaintances) and underwent a pain test.
干预措施: Oxytocin nasal spray (Drug)
OA group
Half an hour after the volunteers inhaled 24 units of oxytocin spray, they watched the pre recorded video (attached with pictures and introductions of acquaintances) and underwent a pain test.
干预措施: Acquaintance (Behavioral)
PA group
Half an hour after the volunteers received the same dose of saline, they watched the pre recorded video (attached with pictures and introductions of acquaintances) and received the pain test.
干预措施: Placebo (Drug)
PA group
Half an hour after the volunteers received the same dose of saline, they watched the pre recorded video (attached with pictures and introductions of acquaintances) and received the pain test.
干预措施: Acquaintance (Behavioral)
结局指标
主要结局
NRS score
时间窗: Half an hour after inhaling spray
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
次要结局
- EEG(about 3 hours)
- Brief Profile Of Mood States(about 3 hours)
- Beck Depression Inventory(about 3 hours)
- WLEIS-C(about 3 hours)
- STAI(about 3 hours)
- BES-C(about 3 hours)
- NRS score(about 3 hours)
- The Positive and Negative Affect Scale(about 3 hours)
研究者
Yi Feng, MD
Head of anesthesiology
Peking University People's Hospital