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

NCT05837546 | Completed DMC

• 1 other identifier: 2023-00206
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Animal-assisted Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intrinsic Motivation Index (IMI)

  3 times per sessions, 1 hours per week, for 3 weeks

• "Multidimensional well-being questionnaire" (MDWBQ)

  3 times + baseline per sessions, 1 hours per week, for 3 weeks

Study Arms (3)

Real dog

EXPERIMENTAL

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

Other: Animal-assisted intervention

replica dog

ACTIVE COMPARATOR

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

Other: Factice dog intervention

plant

ACTIVE COMPARATOR

presence of a plant, contact with participant for 5 minutes

Other: Plant intervention

Interventions

Animal-assisted intervention OTHER

presence of a dog, contact between dog and participant

Real dog

Factice dog intervention OTHER

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

replica dog

Plant intervention OTHER

presence of a plant, contact between plant and participant

plant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Dr. Karin Hediger: lead

Study Sites (1)

University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: within-subject randomized controlled trial with repeated measurement

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

CH (1)