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

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.

Study Overview

• Status: Completed
• Conditions: Animal-assisted Intervention
• Intervention / Treatment: Other: Animal-assisted intervention; Other: Factice dog intervention; Other: Plant intervention

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4055
      • University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real dog; presence of a real dog, contact with participant for 5 minutes	Other: Animal-assisted intervention; presence of a dog, contact between dog and participant
Active Comparator: replica dog; presence of a replica dog, contact with participant for 5 minutes	Other: Factice dog intervention; presence of a factice dog, contact between factice dog and participant
Active Comparator: plant; presence of a plant, contact with participant for 5 minutes	Other: Plant intervention; presence of a plant, contact between plant and participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frontal alpha asymmetry (FAA)	difference between right and left hemispheres of the log transformed values of the averaged alpha power: (ln[right]-ln[left])	3 times + baseline per sessions, 1 hours per week, for 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrinsic Motivation Index (IMI)	questionnaire reporting motivation after a task	3 times per sessions, 1 hours per week, for 3 weeks
"Multidimensional well-being questionnaire" (MDWBQ)	questionnaire reporting general state of mind	3 times + baseline per sessions, 1 hours per week, for 3 weeks

Collaborators and Investigators

• Sponsor: Dr. Karin Hediger

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-00206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No