Animal-assisted InterventionNMAAINCT05837546
Neurodynamic of the Human Brain Underlying Animal-assisted Intervention in Healthy Adults
A study testing Animal-assisted intervention, Factice dog intervention and Plant intervention in people with Animal-assisted Intervention, run by Dr. Karin Hediger at 1 site in Switzerland.
Trial summary
The electrical activity of the brain will be studied using EEG on healthy young adults. The frontal alpha asymmetry (FAA) of the participant will be measured during three conditions: presence of a dog, presence of a replica dog, presence of a plant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Animal-assisted Intervention
- What is being tested?
- Animal-assisted intervention, Factice dog intervention and Plant intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2023to 3 Jul 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give informed consent as documented by signature
- Age ≥ 18 years
Who cannot join
- Fear of or allergies to dogs (self-reported)
- Any acute or chronic disease (e.g. chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
- Current medications (e.g. psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
- Current or regular drug consumption (THC (24h before visit), cocaine, heroin, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The electrical activity of the brain will be studied using EEG on healthy young adults. The frontal alpha asymmetry (FAA) of the participant will be measured during three conditions: presence of a dog, presence of a replica dog, presence of a plant. The researchers hypothesize that the activity in the left frontal hemisphere is greater than in the right during an animal-assisted intervention compared to the control conditions.
Read the detailed description
The primary objective of this study is to measure the alpha power spectrum of an electroencephalogram measurements in the prefrontal cortex of healthy adults during an AAI. The investigators aim to measure established biomarkers of motivation and positive emotions in the EEG recordings and associate them with the AAI. The investigators will use three pair of electrodes to focus on the frontal and prefrontal cortex: F3-F4/F7-F8 and Fp1-Fp1 according to the international 10-20 system to calculate three FAAs. The study is a within-subject randomized controlled trial with repeated measurement. All participants are assigned to the same procedures: Each participant will have 3 measurements in 3 independent sessions. In each session the participants are exposed to 3 conditions (in total participant are exposed 3 times to each condition, once per session). The order of the exposition is randomized for every session. The intervention is an animal-assisted intervention. Usually, an animal is involved in a treatment with the aim of enhancing a therapeutic aim. In our study, there is no therapeutic setting but rather just the presence of a dog. The investigators describe "presence" by, whenever possible, a physical contact between the dog and the participant. This contact will be established by instructing the dog to lie down next to the participant and by instructing the participant to gently pet the dog. This contact cannot be guaranteed during the whole duration of the measurement because the dog is a living creature and will not be forced to do anything against its will.
As control conditions the investigators use a replica therapy dog (Joy for All) and a condition with no dog but the presence of a plant. The plant was chosen as to control for the mere presence and engagement with an object and because the impact of the presence of a plant in the frontal brain electrical activity has been studied before. In both control conditions, the intervention will be as similar as possible to the real dog condition with a physical contact between the object and the participants.
- Conditions
- Animal-assisted Intervention
- Being tested
- Animal-assisted intervention, Factice dog intervention, Plant intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted interventionOther
presence of a dog, contact between dog and participant
Factice dog interventionOther
presence of a factice dog, contact between factice dog and participant
Plant interventionOther
presence of a plant, contact between plant and participant
| Study group | Role | What they receive |
|---|---|---|
| Real dog | Experimental | presence of a real dog, contact with participant for 5 minutes Receives: Other: Animal-assisted intervention |
| replica dog | Active comparator | presence of a replica dog, contact with participant for 5 minutes Receives: Other: Factice dog intervention |
| plant | Active comparator | presence of a plant, contact with participant for 5 minutes Receives: Other: Plant intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
frontal alpha asymmetry (FAA)
difference between right and left hemispheres of the log transformed values of the averaged alpha power: (ln[right]-ln[left])
Measured: 3 times + baseline per sessions, 1 hours per week, for 3 weeks
Secondary outcomes (2)
Intrinsic Motivation Index (IMI)
questionnaire reporting motivation after a task
Measured: 3 times per sessions, 1 hours per week, for 3 weeks
"Multidimensional well-being questionnaire" (MDWBQ)
questionnaire reporting general state of mind
Measured: 3 times + baseline per sessions, 1 hours per week, for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 May 2023
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Animal-assisted InterventionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- within-subject randomized controlled trial with repeated measurement
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Karin Hediger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Karin Hediger, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837546
- Sponsor's protocol ID
- 2023-00206
- Other IDs
- 2023
- Acronym
- NMAAI
- Status last verified
- Jul 2023
- First submitted
- 21 Mar 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodynamic of the Human Brain Underlying Animal-assisted Intervention in Healthy Adults
- ClinicalTrials.gov ID
- NCT05837546
- Acronym / sponsor ID
- NMAAI / 2023-00206
- Conditions
- Animal-assisted Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Karin HedigerUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 1 May 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.
The electrical activity of the brain will be studied using EEG on healthy young adults. The frontal alpha asymmetry (FAA) of the participant will be measured during three conditions: presence of a dog, presence of a replica dog, presence of a plant. The researchers hypothesize that the activity in the left frontal hemisphere is greater than in the right during an animal-assisted intervention compared to the control conditions.
Detailed description
The primary objective of this study is to measure the alpha power spectrum of an electroencephalogram measurements in the prefrontal cortex of healthy adults during an AAI. The investigators aim to measure established biomarkers of motivation and positive emotions in the EEG recordings and associate them with the AAI. The investigators will use three pair of electrodes to focus on the frontal and prefrontal cortex: F3-F4/F7-F8 and Fp1-Fp1 according to the international 10-20 system to calculate three FAAs. The study is a within-subject randomized controlled trial with repeated measurement. All participants are assigned to the same procedures: Each participant will have 3 measurements in 3 independent sessions. In each session the participants are exposed to 3 conditions (in total participant are exposed 3 times to each condition, once per session). The order of the exposition is randomized for every session. The intervention is an animal-assisted intervention. Usually, an animal is involved in a treatment with the aim of enhancing a therapeutic aim. In our study, there is no therapeutic setting but rather just the presence of a dog. The investigators describe "presence" by, whenever possible, a physical contact between the dog and the participant. This contact will be established by instructing the dog to lie down next to the participant and by instructing the participant to gently pet the dog. This contact cannot be guaranteed during the whole duration of the measurement because the dog is a living creature and will not be forced to do anything against its will.
As control conditions the investigators use a replica therapy dog (Joy for All) and a condition with no dog but the presence of a plant. The plant was chosen as to control for the mere presence and engagement with an object and because the impact of the presence of a plant in the frontal brain electrical activity has been studied before. In both control conditions, the intervention will be as similar as possible to the real dog condition with a physical contact between the object and the participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- within-subject randomized controlled trial with repeated measurement
| Arm | Type | Receives |
|---|---|---|
| Real dog | Experimental | Other: Animal-assisted interventionpresence of a real dog, contact with participant for 5 minutes |
| replica dog | Active comparator | Other: Factice dog interventionpresence of a replica dog, contact with participant for 5 minutes |
| plant | Active comparator | Other: Plant interventionpresence of a plant, contact with participant for 5 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to give informed consent as documented by signature
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Fear of or allergies to dogs (self-reported)
- Any acute or chronic disease (e.g. chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes)
- Current medications (e.g. psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
- Current or regular drug consumption (THC (24h before visit), cocaine, heroin, etc.)
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 |
|---|---|---|
| Animal-assisted interventionpresence of a dog, contact between dog and participant | Other | Real dog |
| Factice dog interventionpresence of a factice dog, contact between factice dog and participant | Other | replica dog |
| Plant interventionpresence of a plant, contact between plant and participant | Other | plant |
Primary outcome
frontal alpha asymmetry (FAA)
Time frame: 3 times + baseline per sessions, 1 hours per week, for 3 weeks
difference between right and left hemispheres of the log transformed values of the averaged alpha power: (ln[right]-ln[left])
2 secondary outcomes
Intrinsic Motivation Index (IMI)
Time frame: 3 times per sessions, 1 hours per week, for 3 weeks
"Multidimensional well-being questionnaire" (MDWBQ)
Time frame: 3 times + baseline per sessions, 1 hours per week, for 3 weeks
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 12 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Animal-assisted Intervention
Not yet recruiting
Benefits of Judicial Assistance Dogs for Child Victims in Child Advocacy and Pediatric Assessment Units (UAPEDs)
Animal-Human Bonding, Animal-assisted Intervention
Not yet recruiting
Animal-Assisted Therapy Combined With Standard Rehabilitation for Motor Recovery in Dementia Patients in a Medical and Rehabilitation Care Unit
Dementia, Cognitive Dysfunction ( MMSE < 24 )
Recruiting
Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
Situational Anxiety, Behavior
Active, not recruiting
Multi-site Animal Assisted Intervention for Children With DD and Their Family Dog
Physical Activity, Social Wellbeing
Not yet recruiting
Horse-assisted Intervention, Heart Rate Variability & Stress
Psychological Stress
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 study testing Animal-assisted intervention, Factice dog intervention and Plant intervention in people with Animal-assisted Intervention, run by Dr. Karin Hediger at 1 site in Switzerland.
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 2 inclusion and 4 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 12 Jul 2023. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
frontal alpha asymmetry (FAA) (time frame: 3 times + baseline per sessions, 1 hours per week, for 3 weeks). 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 12 Jul 2023.