Back to resultsEffect of Oxytocin Nasal Inhalation on Empathy Analgesia
Primary Purpose
Oxytocin, Pain, Empathy
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo
Stranger
Acquaintance
Sponsored by
About this trial
This is an interventional treatment trial for Oxytocin
Eligibility Criteria
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)
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
OS group
PS group
OA group
PA group
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
NRS score
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
Secondary Outcome Measures
EEG
Frequency of electroencephalogram
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.
Beck Depression Inventory
Beck Depression Inventory
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.
STAI
state-trait anxiety inventory
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.
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").
NRS score
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
Full Information
NCT ID
NCT05823441
First Posted
March 28, 2023
Last Updated
July 7, 2023
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05823441
Brief Title
Effect of Oxytocin Nasal Inhalation on Empathy Analgesia
Official Title
Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2023 (Anticipated)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxytocin, Pain, Empathy, Social Familiarity, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OS group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
PS group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
OA group
Arm Type
Experimental
Arm Description
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.
Arm Title
PA group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
Volunteers inhale 24 units of oxytocin spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Volunteers inhale 24 units of placebo spray
Intervention Type
Behavioral
Intervention Name(s)
Stranger
Intervention Description
Volunteers watch a video of a pain test and attach a photo of a stranger
Intervention Type
Behavioral
Intervention Name(s)
Acquaintance
Intervention Description
Volunteers watch a video of a pain test and attach a photo of an acquaintance
Primary Outcome Measure Information:
Title
NRS score
Description
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
Time Frame
Half an hour after inhaling spray
Secondary Outcome Measure Information:
Title
EEG
Description
Frequency of electroencephalogram
Time Frame
about 3 hours
Title
Brief Profile Of Mood States
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.
Time Frame
about 3 hours
Title
Beck Depression Inventory
Description
Beck Depression Inventory
Time Frame
about 3 hours
Title
WLEIS-C
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.
Time Frame
about 3 hours
Title
STAI
Description
state-trait anxiety inventory
Time Frame
about 3 hours
Title
BES-C
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.
Time Frame
about 3 hours
Title
The Positive and Negative Affect Scale
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").
Time Frame
about 3 hours
Title
NRS score
Description
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
Time Frame
about 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Feng
Phone
13601083503
Email
doctor_yifeng@sina.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
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Effect of Oxytocin Nasal Inhalation on Empathy Analgesia
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