OxytocinPhase 4NCT05823441
Effect of Oxytocin Nasal Inhalation on Empathy Analgesia
A Phase 4 study testing Oxytocin nasal spray, Stranger and Acquaintance in people with Oxytocin and Pain, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Oxytocin nasal spray, Stranger and Acquaintance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2023to 21 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial
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.
- Conditions
- Oxytocin, Pain, Empathy, Social Familiarity, Analgesia
- Being tested
- Oxytocin nasal spray, Placebo, Stranger, Acquaintance
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Volunteers inhale 24 units of oxytocin spray
PlaceboDrug
Volunteers inhale 24 units of placebo spray
StrangerBehavioural
Volunteers watch a video of a pain test and attach a photo of a stranger
AcquaintanceBehavioural
Volunteers watch a video of a pain test and attach a photo of an acquaintance
| Study group | Role | What they receive |
|---|---|---|
| OS group | Placebo comparator | 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. Receives: Drug: Oxytocin nasal spray; Behavioral: Stranger |
| PS group | Placebo comparator | 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. Receives: Drug: Placebo; Behavioral: Stranger |
| OA group | Experimental | 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. Receives: Drug: Oxytocin nasal spray; Behavioral: Acquaintance |
| PA group | Placebo comparator | 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. Receives: Drug: Placebo; Behavioral: Acquaintance |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
Measured: Half an hour after inhaling spray
Secondary outcomes (8)
EEG
Frequency of electroencephalogram
Measured: about 3 hours
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.
Measured: about 3 hours
Beck Depression Inventory
Beck Depression Inventory
Measured: about 3 hours
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.
Measured: about 3 hours
STAI
state-trait anxiety inventory
Measured: about 3 hours
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.
Measured: about 3 hours
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").
Measured: about 3 hours
NRS score
numerical rating scale of pain， ranging from 0 = "no pain" to 10 = "the most intense pain that is tolerable".
Measured: about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start3 Jun 2023
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxytocinStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823441
- Sponsor's protocol ID
- 2022PHD012-001
- Status last verified
- Jan 2024
- First submitted
- 28 Mar 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin Nasal Inhalation and Social Familiarity on Empathy Analgesia: a Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05823441
- Acronym / sponsor ID
- 2022PHD012-001
- Conditions
- Oxytocin, Pain, Empathy, Social Familiarity, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OS group | Placebo comparator | Drug: Oxytocin nasal spray, Behavioral: StrangerHalf 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. |
| PS group | Placebo comparator | Drug: Placebo, Behavioral: StrangerHalf 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. |
| OA group | Experimental | Drug: Oxytocin nasal spray, Behavioral: AcquaintanceHalf 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. |
| PA group | Placebo comparator | Drug: Placebo, Behavioral: AcquaintanceHalf 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal sprayVolunteers inhale 24 units of oxytocin spray | Drug | OA group, OS group |
| PlaceboVolunteers inhale 24 units of placebo spray | Drug | PA group, PS group |
| StrangerVolunteers watch a video of a pain test and attach a photo of a stranger | Behavioural | OS group, PS group |
| AcquaintanceVolunteers watch a video of a pain test and attach a photo of an acquaintance | Behavioural | OA group, PA group |
Primary outcome
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".
8 secondary outcomes
EEG
Time frame: about 3 hours
Brief Profile Of Mood States
Time frame: about 3 hours
Beck Depression Inventory
Time frame: about 3 hours
WLEIS-C
Time frame: about 3 hours
STAI
Time frame: about 3 hours
BES-C
Time frame: about 3 hours
The Positive and Negative Affect Scale
Time frame: about 3 hours
NRS score
Time frame: about 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin nasal spray, Stranger and Acquaintance in people with Oxytocin and Pain, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS score (time frame: Half an hour after inhaling spray). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.