Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

NCTNCT05823441Other id2022PHD012-001

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 120 participants (actual)
Sponsor: Peking University People's Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 3 Jun 2023
Primary completion: 21 Jan 2024
Completion: 21 Jan 2024
First posted: 21 Apr 2023
Last update posted: 1 Feb 2024
Conditions: Oxytocin · Pain · Empathy · Social Familiarity · Analgesia

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 4
Effect of Oxytocin Nasal Inhalation on Empathy Analgesia
NCT05823441
3 Jun 2023 to 21 Jan 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Oxytocin nasal sprayDrug
PlaceboDrug
StrangerBehavioral
AcquaintanceBehavioral

Arms4

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.
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.
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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

NRS score
Time frame · Half an hour after inhaling spray
Registry description
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".

Secondary outcomes(8)

EEG
Time frame · about 3 hours
Registry description
Frequency of electroencephalogram
Brief Profile Of Mood States
Time frame · about 3 hours
Registry description
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.
Beck Depression Inventory
Time frame · about 3 hours
Registry description
Beck Depression Inventory
WLEIS-C
Time frame · about 3 hours
Registry description
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.
STAI
Time frame · about 3 hours
Registry description
state-trait anxiety inventory
BES-C
Time frame · about 3 hours
Registry description
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.
The Positive and Negative Affect Scale
Time frame · about 3 hours
Registry description
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").
NRS score
Time frame · about 3 hours
Registry description
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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)

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