Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Analgesia; Oxytocin; Empathy; Social Familiarity
• Intervention / Treatment: Drug: Oxytocin nasal spray; Behavioral: Stranger; Drug: Placebo; Behavioral: Acquaintance

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yi Feng; Phone Number: 13601083503; Email: doctor_yifeng@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Oxytocin nasal spray; Volunteers inhale 24 units of oxytocin spray; Behavioral: Stranger; Volunteers watch a video of a pain test and attach a photo of a stranger
Placebo Comparator: 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.	Behavioral: Stranger; Volunteers watch a video of a pain test and attach a photo of a stranger; Drug: Placebo; Volunteers inhale 24 units of placebo spray
Experimental: 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.	Drug: Oxytocin nasal spray; Volunteers inhale 24 units of oxytocin spray; Behavioral: Acquaintance; Volunteers watch a video of a pain test and attach a photo of an acquaintance
Placebo Comparator: 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.	Drug: Placebo; Volunteers inhale 24 units of placebo spray; Behavioral: Acquaintance; Volunteers watch a video of a pain test and attach a photo of an acquaintance

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
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
EEG	Frequency of electroencephalogram	about 3 hours

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2023
• Primary Completion (Actual): January 21, 2024
• Study Completion (Actual): January 21, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 8, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 2022PHD012-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No