Neurodynamic of the Human Brain Underlying Animal-assisted Intervention in Healthy Adults

NCT ID: NCT05837546

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-07-03

Brief Summary

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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

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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

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Animal-assisted Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

within-subject randomized controlled trial with repeated measurement
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Due to the nature of the conditions, the experimenters and the participants cannot be blinded as it is obvious if the animal is present or not. Nevertheless, participants will not be informed of the order of the conditions before the beginning of the measurement and to minimize bias they will not be informed about our hypotheses and that we are interested in the effects of the presence of a dog.

Study Groups

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Real dog

presence of a real dog, contact with participant for 5 minutes

Group Type EXPERIMENTAL

Animal-assisted intervention

Intervention Type OTHER

presence of a dog, contact between dog and participant

replica dog

presence of a replica dog, contact with participant for 5 minutes

Group Type ACTIVE_COMPARATOR

Factice dog intervention

Intervention Type OTHER

presence of a factice dog, contact between factice dog and participant

plant

presence of a plant, contact with participant for 5 minutes

Group Type ACTIVE_COMPARATOR

Plant intervention

Intervention Type OTHER

presence of a plant, contact between plant and participant

Interventions

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Animal-assisted intervention

presence of a dog, contact between dog and participant

Intervention Type OTHER

Factice dog intervention

presence of a factice dog, contact between factice dog and participant

Intervention Type OTHER

Plant intervention

presence of a plant, contact between plant and participant

Intervention Type OTHER

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Karin Hediger

OTHER

Sponsor Role lead

Responsible Party

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Dr. Karin Hediger

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2023-00206

Identifier Type: -

Identifier Source: org_study_id

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