Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001208392
Ethics application status
Approved
Date submitted
14/08/2017
Date registered
18/08/2017
Date last updated
28/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation into the role of oxytocin in emotion after injury or trauma
Scientific title
An investigation into the role of oxytocin in emotion after injury or trauma
Secondary ID [1] 292649 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals who have experienced a traumatic injury. 304381 0
Condition category
Condition code
Injuries and Accidents 303709 303709 0 0
Other injuries and accidents
Mental Health 303756 303756 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxytocin (24 International Units) administered via nasal spray. Participants will self administer the intranasal spray under verbal instructions from the researcher. Participants will be instructed to keep the bottle in an upright position during the puffing. Before
puffing commences, four pre-puffs will squirted from the spray bottle by the
researcher to ensure normal distribution of each spray before use. The order of
administration was always as follow: insert spray-head, exhale, puff, inhale nasally. Administration will alternate between the nostrils after each spray, with 45-second break between each administration, until 3 puffs (4 IU each) per nostril is reached (total dose 24 IU). Participants were allowed to blow their noses before puffing commenced and will be asked to avoid this until the end of the testing sessions. They will be allowed to dab off any leaking fluid from their noses with a tissue. A stopwatch will be used to time the 45-second breaks, and again after the last puff to keep time until the expected peak levels of oxytocin within the central nervous system (approximately 45 minutes after the administration of the last spray).

As this is a randomised crossover trial, participants will receive the oxytocin nasal spray in one session, and the placebo spray in the other. The two sessions are separated by a minimum of 7 days. Following the administration of the sprays and waiting for the sprays to become active within the central nervous system, the researcher will guide participants through a series of experimental tasks, which are described below.

Task 1: Oxytocin, heart rate variability, and stress
When the participant is comfortable, heart rate will be recorded while participants are prompted to inhale and exhale at regular intervals of 15 cycles per minute for two minutes. Spectral analysis with Fast Fourier Transformation will compute variability in low and high frequency heart periods (HRV). Respiratory sinus arrhythmia (RSA) will be analysed with the peak-to-valley method, calculating the mean difference between the shortest heart R-R period during inspiration and the longest R-R period during expiration. Following the paced breathing task, participants will be asked to complete a cognitive stressor task, the Serial Sevens (SS) task to induce a state of stress. Participants will be instructed to count backwards by sevens (e.g., 1,000, 993, 986, 979 etc.) while the experimenter pressures them to “hurry up” and “go faster” over a period of two minutes.

Task 2: Film stimuli task
Participants will then be asked to view and rate the emotional film clips. This task will take about 20 minutes. After the emotional film protocol, participants will be given a post-stimulus questionnaire, where they will be asked to rate a series of questions on a 5-point likert scale from 1 (Strongly disagree) to 5 (Strongly Agree). Each session will present 14 different clips, which will be matched on emotional stimulus type (neutral, positive, negative, fear) and valence and arousal.
Intervention code [1] 298879 0
Treatment: Drugs
Comparator / control treatment
Placebo nasal spray that contains the same ingredients as the intervention, minus the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 303075 0
Subjective ratings of arousal using an 11-point numerical rating scale (NRS) in response to the presentation of the emotional film stimuli.
Timepoint [1] 303075 0
Ratings collected following the presentation of the emotional film stimuli.
Secondary outcome [1] 337829 0
Heart rate variability as measured by a 5 lead electrocardiograph system at rest and during a counting task.
Timepoint [1] 337829 0
Heart rate is recorded continuously throughout Task 1 in both testing sessions, 45 minutes post nasal spray administration.
Secondary outcome [2] 337830 0
Maximum change in heart rate/heart rate variability measured by a 5 lead electrocardiograph system between the emotionally-valenced (e.g., happy, fearful) and neutral film stimuli.
Timepoint [2] 337830 0
Heart rate/heart rate variability are monitored continuously throughout the duration of the emotional film stimuli task.
Secondary outcome [3] 337831 0
Maximum change skin conductance response measured by skin conductance finger electrodes between the emotionally-valenced (e.g., happy, fearful) and neutral film stimuli.
Timepoint [3] 337831 0
Skin conductance response is monitored continuously throughout the duration of the emotional film stimuli task.
Secondary outcome [4] 337832 0
Subjective ratings of the emotional nature of the film stimulus using an 11-point numerical rating scale (NRS) in response to the presentation of the emotional film stimuli.

Timepoint [4] 337832 0
Ratings collected following the presentation of the emotional film stimuli.
Secondary outcome [5] 337833 0
Subjective ratings of participants own emotional state using an 11-point numerical rating scale (NRS) in response to the presentation of the emotional film stimuli.

Timepoint [5] 337833 0
Ratings collected following the presentation of the emotional film stimuli.
Secondary outcome [6] 337834 0
Subjective ratings of vicarious sensations felt during the presentation of the emotional film stimuli using an 11-point numerical rating scale (NRS).
Timepoint [6] 337834 0
Ratings collected following the presentation of the emotional film stimuli.
Secondary outcome [7] 337835 0
Subjective ratings of affective empathy using an 11-point numerical rating scale (NRS) in response to the presentation of the emotional film stimuli.

Timepoint [7] 337835 0
Ratings collected following the presentation of the emotional film stimuli.
Secondary outcome [8] 337836 0
Subjective ratings of cognitive empathy using an 6-point numerical rating scale (NRS) in response to the presentation of the emotional film stimuli.
Timepoint [8] 337836 0
Ratings collected following the presentation of the emotional film stimuli.

Eligibility
Key inclusion criteria
Individuals with normal or corrected-to-normal vision who have experienced an unintentional traumatic injury (i.e., an injury that was not from self-harm) over the last 6-24 months.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of a neurological or psychiatric disorder; current substance dependence (including illicit drugs and alcohol involving withdrawal symptoms); hypertension/heart disease; currently taking medications (apart from the oral contraceptive pill); if injury was the result of self-harm; pregnancy or breastfeeding, traumatic brain injury, any known allergies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nasal sprays will be labelled with a code specific for participants as they are recruited. The compounding chemist will provide a randomisation schedule to ensure the study follows a double-blind cross-over randomised controlled trial experimental design. This randomisation schedule will be kept by an individual not involved in the recruitment or screening of participants, the administration of the sprays, or data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation of the drugs will be conducted by the clinical trials pharmacist by means of a computerised method using Microsoft Windows Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
This was a student-driven project. Student completed degree and recruitment was stopped.
Date of first participant enrolment
Anticipated
Actual
2/05/2016
Date of last participant enrolment
Anticipated
31/01/2018
Actual
29/08/2016
Date of last data collection
Anticipated
31/08/2018
Actual
29/08/2016
Sample size
Target
25
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297277 0
University
Name [1] 297277 0
Monash University
Country [1] 297277 0
Australia
Funding source category [2] 297296 0
Government body
Name [2] 297296 0
Australian Research Council
Country [2] 297296 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria
3800
Country
Australia
Secondary sponsor category [1] 296268 0
None
Name [1] 296268 0
Address [1] 296268 0
Country [1] 296268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298394 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 298394 0
Ethics committee country [1] 298394 0
Australia
Date submitted for ethics approval [1] 298394 0
Approval date [1] 298394 0
28/04/2016
Ethics approval number [1] 298394 0
CF16/931 - 2016000487

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76938 0
Dr Melita Giummarra
Address 76938 0
School of Public Health and Preventive Medicine
Monash University
553 Commercial Road
MELBOURNE VIC 3000
Country 76938 0
Australia
Phone 76938 0
+61 3 9903 0365
Fax 76938 0
Email 76938 0
[email protected]
Contact person for public queries
Name 76939 0
Monica Perkins
Address 76939 0
C/O ENRU
School of Psychological Sciences
18 Innovation Walk
Monash University
Clayton VIC 3800
Country 76939 0
Australia
Phone 76939 0
+ 61 467 638 865
Fax 76939 0
Email 76939 0
[email protected]
Contact person for scientific queries
Name 76940 0
Monica Perkins
Address 76940 0
C/O ENRU
School of Psychological Sciences
18 Innovation Walk
Monash University
Clayton VIC 3800
Country 76940 0
Australia
Phone 76940 0
+61 467 638 865
Fax 76940 0
Email 76940 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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