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

Sponsor
Dr. Karin Hediger (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05837546
Collaborator
(none)
30
3
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Animal-assisted intervention
  • Other: Factice dog intervention
  • Other: Plant intervention
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
within-subject randomized controlled trial with repeated measurementwithin-subject randomized controlled trial with repeated measurement
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
Neurodynamic of the Human Brain Underlying Animal-assisted Intervention in Healthy Adults
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. frontal alpha asymmetry (FAA) [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])

Secondary Outcome Measures

  1. Intrinsic Motivation Index (IMI) [3 times per sessions, 1 hours per week, for 3 weeks]

    questionnaire reporting motivation after a task

  2. "Multidimensional well-being questionnaire" (MDWBQ) [3 times + baseline per sessions, 1 hours per week, for 3 weeks]

    questionnaire reporting general state of mind

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dr. Karin Hediger

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Karin Hediger, Professor, University of Basel
ClinicalTrials.gov Identifier:
NCT05837546
Other Study ID Numbers:
  • 2023-00206
First Posted:
May 1, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2023