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Completed

NCT Number: NCT05823441

Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

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.

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Key information

Conditions

Oxytocin Agnosia Analgesia Empathy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Social Familiarity

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxytocin nasal spray

Drug

Volunteers inhale 24 units of oxytocin spray

Placebo

Drug

Volunteers inhale 24 units of placebo spray

Stranger

Behavioral

Volunteers watch a video of a pain test and attach a photo of a stranger

Acquaintance

Behavioral

Volunteers watch a video of a pain test and attach a photo of an acquaintance

Primary outcomes

  1. NRS score

    Time frame: 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".

Secondary outcomes

  1. EEG

    Time frame: about 3 hours

    Frequency of electroencephalogram

  2. Brief Profile Of Mood States

    Time frame: about 3 hours

    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.

  3. Beck Depression Inventory

    Time frame: about 3 hours

    Beck Depression Inventory

  4. WLEIS-C

    Time frame: about 3 hours

    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.

  5. STAI

    Time frame: about 3 hours

    state-trait anxiety inventory

  6. BES-C

    Time frame: about 3 hours

    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.

  7. The Positive and Negative Affect Scale

    Time frame: about 3 hours

    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").

  8. NRS score

    Time frame: about 3 hours

    numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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