Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial

Conditions
-----------------
Oxytocin, Pain, Empathy, Social Familiarity, Analgesia

Intervention / Treatment
-----------------
* Drug: Oxytocin nasal spray
* Drug: Placebo
* Behavioral: Stranger
* Behavioral: Acquaintance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: OS group<br>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. | Drug: Oxytocin nasal spray<br>* Volunteers inhale 24 units of oxytocin spray<br>Behavioral: Stranger<br>* Volunteers watch a video of a pain test and attach a photo of a stranger<br>|
| Placebo Comparator: PS group<br>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. | Drug: Placebo<br>* Volunteers inhale 24 units of placebo spray<br>Behavioral: Stranger<br>* Volunteers watch a video of a pain test and attach a photo of a stranger<br>|
| Experimental: OA group<br>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. | Drug: Oxytocin nasal spray<br>* Volunteers inhale 24 units of oxytocin spray<br>Behavioral: Acquaintance<br>* Volunteers watch a video of a pain test and attach a photo of an acquaintance<br>|
| Placebo Comparator: PA group<br>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. | Drug: Placebo<br>* Volunteers inhale 24 units of placebo spray<br>Behavioral: Acquaintance<br>* Volunteers watch a video of a pain test and attach a photo of an acquaintance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score | numerical rating scale of pain， ranging from 0 = no pain to 10 = the most intense pain that is tolerable. | Half an hour after inhaling spray | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG | Frequency of electroencephalogram | about 3 hours | 
| Brief Profile Of Mood States | Brief Profile Of Mood States is a 30 item self-report psychological instrument intended for use with adults age 18 and above. Response format consisted of the following 5-point Likert scales: 0：not at all; 1：a little; 2：moderately; 3：quite a bit; and 4：extremely. | about 3 hours | 
| Beck Depression Inventory | Beck Depression Inventory | about 3 hours | 
| WLEIS-C | The English version of the scale was developed by Wong and Law and used as an evaluation tool for emotional intelligence level surveys, the Chinese version of emotional intelligence level consists of 16 items scale (WLEIS-C) , including self-emotional perception (4 items), others' emotional perception (4 items), emotional control (4 items), emotional use (4 items) 4 Dimensions, a total of 16 items. Using Likert 7-level scoring method, '0' stands for 'very disagree' and '6' stands for 'very agree'. The higher the score, the higher the emotional intelligence level. | about 3 hours | 
| STAI | state-trait anxiety inventory | about 3 hours | 
| BES-C | Chinese version of Basic Empathy Scale.The scale was divided into two dimensions: emotional empathy, which comprised 11 items, and cognitive empathy, which comprised nine items, yielding a total of 20 items (including eight reverse-scoring items). A five-point Likert scale was used, where 1 = completely disagree and 5 = completely agree. A high score indicated strong empathy. | about 3 hours | 
| The Positive and Negative Affect Scale | is a 20 item self-report psychological instrument，contains 10 items for positive and 10 items for negative emotions. All the items are rated on a scale ranging from 1 (very slightly or not at all) to 5 (extremely). | about 3 hours | 
| NRS score | numerical rating scale of pain， ranging from 0 = no pain to 10 = the most intense pain that is tolerable. | about 3 hours |