Measuring Effects of Contact to Dogs

November 9, 2021 updated by: University of Aarhus

Measuring the Effects of Different Intensities of Contact to Dogs

The study aims to identify and quantify objective non-invasive measures of the immediate effect of contact with dogs in a standardized experimental setup. Employing a within-subject design, the study includes healthy participants that are exposed to three different levels of contact to a dog compared with a no-dog control condition while obtaining measures of both physiological, behavioral, and psychological effects.

Study Overview

Detailed Description

Using a within-subjects design, we will compare four standardised and controlled test situations with different levels of dog contact:

1) visual (V), 2) tactile and visual (TV), 3) tactile, visual, interaction (TVI), and 4)control (C).

The participants will be subjected to all four test situations on the same day, and will be randomly allocated to test order.

On the test day, we collect background information and baseline measures for the participants (baseline period, duration: 50 minutes), whereafter they rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the four test situations (10 minutes each) that are followed by rest intervals (30 minutes each).

The participants' interaction with the dog during the 10-minute test situations are standardised according to the specific contact treatment. Most physiological and all behavioural measures are recorded continuously throughout each test in order for us to link the "dosage" of dog (the different levels of contact) with the psychological responses and some physiological measures obtained before an after each test situation.

Below is shown the exact time schedule of the test day, that we refer to when describing the outcome measures. The baseline period (30 minutes) is not included in the total test period (total duration= 190 minutes), that consist of a pre-intervention and intervention period.

  • Baseline period (50 minutes - not part of total test period)
  • Pre-intervention period (start, t=0 minutes; end t= 30 minutes)
  • Test situation 1 (start, t=30 minutes; end, t=40 minutes)
  • Rest period 1 (start, t=40 minutes, end, t= 70 minutes)
  • Test situation 2 (start, t=70 minutes; end, t=80 minutes)
  • Rest period 2 (start, t=80 minutes, end, t= 110 minutes)
  • Test situation 3 (start, t=110 minutes; end, t=120 minutes)
  • Rest period 3 (start, t=120 minutes, end, t= 150 minutes)
  • Test situation 4 (start, t=150 minutes; end, t=160 minutes)
  • Rest period 4 (start, t=160 minutes, end, t= 190 minutes)

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tjele, Denmark, DK-8830
        • Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal cognitive functioning and physical movement
  • Ability to speak and read Danish

Exclusion Criteria:

  • Known medical, psychiatric or neurological disease
  • Use of psychotropic medications
  • Frequent use of pain medication
  • Use of illegal psychotropic drugs
  • Known allergies to dogs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ANIMAL CONTACT 1
Only one arm - within-subject design
Each subject is exposed to four test situations of 10 minutes. Three situations with increasing intensity of dog contact, and one control test situation with no contact to a dog. The order of the test situations is random and with 30 minute washout in-between

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological measure, heart rate
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
The test person wears self-adhesive electrodes and the heart rate is measured non-invasively,
Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Physiological measure, blood pressure
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately following the first test situation: t= 40 minutes
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately following the first test situation: t= 40 minutes
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately preceeding the second test situation: t= 70 minutes
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately following the second test situation: t= 80 minutes
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately following the third test situation: t= 120 minutes.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately following the third test situation: t= 120 minutes.
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes.
Physiological measure, blood pressure
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Physiological measure, blood pressure
Time Frame: After the last resting period: Measured at the end of the last resting period, following the last of the four test situations: t= 190 minutes
Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
After the last resting period: Measured at the end of the last resting period, following the last of the four test situations: t= 190 minutes
Physiological measure, heart rate variablility
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Heart rate variability is calculated from heart rate data
Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Physiological measure, galvanic skin response
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
The test person is fitted with electrodes on two fingers and galvanic skin response is measured non-invasively,
Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Salivary cortisol
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Salivary cortisol
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately following the first test situation: t=40 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the first test situation: t=40 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately preceeding the second test situation: t=70 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the second test situation: t=70 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately following the second test situation: t=80 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the second test situation: t=80 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately preceeding the third test situation: t=110 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the third test situation: t=110 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately following the third test situation: t=120 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the third test situation: t=120 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes.
Salivary cortisol
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Salivary cortisol
Time Frame: After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes
Salivary oxytocin
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Salivary oxytocin
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately following the first test situation: t= 40 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the first test situation: t= 40 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the second test situation: t= 70 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the second test situation: t= 80 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately following the third test situation: t= 120 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the third test situation: t= 120 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: 150 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately preceeding the fourth test situation: 150 minutes.
Salivary oxytocin
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Test periods: Measured immediately following the fourth test situation: t=160 minutes.
Salivary oxytocin
Time Frame: After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes
Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
After the last resting period: Measured at the end of the last resting period, following the last of the four test situations; t= 190 minutes
Visual analogue scales measuring expected psychological and physiological effects of the test day including, including all four test situations
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately preceeding the first test situation: t=30 minutes
Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately preceeding the second test situation: t= 70minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately preceeding the second test situation: t= 70minutes
Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately preceeding the third test situation: t= 110 minutes
Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes
Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately following the first test situations: t=40 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately following the first test situations: t=40 minutes
Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately following the second test situation: t= 80 minutes
Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately following the third test situation: t=120 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately following the third test situation: t=120 minutes
Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
Time Frame: Test periods: Measured immediately following the fourth test situation: t= 160 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
Test periods: Measured immediately following the fourth test situation: t= 160 minutes
Visual analogue scales measuring perceived psychological and physiological effects of of the test day including, including all four test situations
Time Frame: After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes
Test persons fill in a visual analoque scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.
After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes
The State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)
Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
The State-Trait Anxiety Inventory (STAI)
Time Frame: Test periods: Measured immediately following the first test situation: t=40 minutes
State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)
Test periods: Measured immediately following the first test situation: t=40 minutes
The State-Trait Anxiety Inventory (STAI)
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)
Test periods: Measured immediately following the second test situation: t= 80 minutes
The State-Trait Anxiety Inventory (STAI)
Time Frame: Test periods: Measured immediately following the third test situation: t= 120 minutes
State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)
Test periods: Measured immediately following the third test situation: t= 120 minutes
The State-Trait Anxiety Inventory (STAI)
Time Frame: Test periods: Measured immediately following the fourth test situation: t= 160 minutes
State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)
Test periods: Measured immediately following the fourth test situation: t= 160 minutes
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from "very little /not at all" to "extremely much". The emotions differ in valens.
Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Test periods: Measured immediately following the first test situation: t= 40 minutes
Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from "very little /not at all" to "extremely much". The emotions differ in valens.
Test periods: Measured immediately following the first test situation: t= 40 minutes
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Test periods: Measured immediately following the second test situation: t= 80 minutes
Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from "very little /not at all" to "extremely much". The emotions differ in valens.
Test periods: Measured immediately following the second test situation: t= 80 minutes
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Test periods: Measured immediately following the third test situation: t=120 minutes
Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from "very little /not at all" to "extremely much". The emotions differ in valens.
Test periods: Measured immediately following the third test situation: t=120 minutes
The Positive and Negative Affect Schedule (PANAS)
Time Frame: Test periods: Measured immediately following the fourth test situation: t=160 minutes
Positive and negative affect is measured with the PANAS scale, where the person scores whether or not they experience each of 20 emotions on a 5-step scale from "very little /not at all" to "extremely much". The emotions differ in valens.
Test periods: Measured immediately following the fourth test situation: t=160 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative behavioural measures - frequencies of behavioural elements
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
A video recording of the test persons behaviour is analysed for frequency of predefined behavioural elements Postures: sitting, standing walkning Touching the dog: being in physical contact with the dog with tha hand or another part of the body Looking at the dog: Having head turned towards the dog Talking to the dog: Directing talk directly at the dog, as opposed to the person present
Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Quantitative behavioural measures - duration of behavioural elements
Time Frame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
A video recording of the test persons behaviour is analysed for the duration (seconds) of predefined behavioural elements Postures: sitting, standing walkning Touching the dog: being in physical contact with the dog with tha hand or another part of the body Looking at the dog: Having head turned towards the dog Talking to the dog: Directing talk directly at the dog, as opposed to the person present
Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Thodberg, Senior Researcher

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ANIMAL CONTACT1
  • 128534 (Other Grant/Funding Number: TrygFonden)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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