Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05823441
• Other study ID #: 2022PHD012-001
• Status: Completed
• Phase: Phase 4
• Start date: June 3, 2023
• Est. completion date: January 21, 2024

Study information

• Verified date: January 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 21, 2024
• Est. primary completion date: January 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia
• Empathy
• Oxytocin
• Pain

Intervention

Drug:
• Oxytocin nasal spray
Volunteers inhale 24 units of oxytocin spray
• Placebo
Volunteers inhale 24 units of placebo spray

Behavioral:
• Stranger
Volunteers watch a video of a pain test and attach a photo of a stranger
• Acquaintance
Volunteers watch a video of a pain test and attach a photo of an acquaintance

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EEG	Frequency of electroencephalogram	about 3 hours
Secondary	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
Secondary	Beck Depression Inventory	Beck Depression Inventory	about 3 hours
Secondary	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
Secondary	STAI	state-trait anxiety inventory	about 3 hours
Secondary	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
Secondary	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
Secondary	NRS score	numerical rating scale of pain, ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".	about 3 hours