Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

Sponsor
Peking University People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823441
Collaborator
(none)
120
1
4
12
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxytocin nasal spray
  • Drug: Placebo
  • Behavioral: Stranger
  • Behavioral: Acquaintance
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Apr 15, 2024
Anticipated Study Completion Date :
Apr 15, 2024

Arms and Interventions

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.

Drug: 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

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

Outcome Measures

Primary Outcome Measures

  1. NRS score [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 Outcome Measures

  1. EEG [about 3 hours]

    Amplitudes of electroencephalogram

  2. Brief Profile Of Mood States [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 [about 3 hours]

    Beck Depression Inventory

  4. WLEIS-C [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 [about 3 hours]

    state-trait anxiety inventory

  6. BES-C [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 [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 [about 3 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University People's Hospital Beijing Beijing China 100044

Sponsors and Collaborators

  • Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yi Feng, MD, Head of anesthesiology, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT05823441
Other Study ID Numbers:
  • 2022PHD012-001
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023