Clinical trial NCT05837546: Neurodynamic of the Human Brain Underlying Animal-assisted Intervention in Healthy Adults
Official title: Neurodynamic of the Human Brain Underlying Animal-assisted Intervention in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Animal-assisted Intervention
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: within-subject randomized controlled trial with repeated measurement
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent as documented by signature
* Age ≥ 18 years

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: frontal alpha asymmetry (FAA)
timeFrame: 3 times + baseline per sessions, 1 hours per week, for 3 weeks
Secondary outcomes:
measure: Intrinsic Motivation Index (IMI)
timeFrame: 3 times per sessions, 1 hours per week, for 3 weeks
measure: "Multidimensional well-being questionnaire" (MDWBQ)
timeFrame: 3 times + baseline per sessions, 1 hours per week, for 3 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: Basel Stadt
Study officials:
References: