Clinical trial NCT04696419: Measuring Effects of Contact to Dogs
Official title: Measuring the Effects of Different Intensities of Contact to Dogs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Responses to Contact With Dogs
Psychological Responses to Contact With Dogs
Behavioural Responses to Contact With Dogs
Keywords: Animal-assisted therapy
Non-invasive measure
Human-animal contact
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomised within-subject design. Each subject is exposed to three different levels of contact with a dog and a control situation in randomised order.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Physiological measure, heart rate
timeFrame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
measure: Physiological measure, blood pressure
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately following the first test situation: t= 40 minutes
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately following the second test situation: t= 80 minutes
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately following the third test situation: t= 120 minutes.
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately preceeding the fourth test situation: t= 150 minutes.
measure: Physiological measure, blood pressure
timeFrame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
measure: Physiological measure, blood pressure
timeFrame: 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
measure: Physiological measure, heart rate variablility
timeFrame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
measure: Physiological measure, galvanic skin response
timeFrame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
measure: Salivary cortisol
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately following the first test situation: t=40 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately preceeding the second test situation: t=70 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately following the second test situation: t=80 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately preceeding the third test situation: t=110 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately following the third test situation: t=120 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes.
measure: Salivary cortisol
timeFrame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
measure: Salivary cortisol
timeFrame: 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
measure: Salivary oxytocin
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately following the first test situation: t= 40 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately preceeding the second test situation: t= 70 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately following the second test situation: t= 80 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately following the third test situation: t= 120 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately preceeding the fourth test situation: 150 minutes.
measure: Salivary oxytocin
timeFrame: Test periods: Measured immediately following the fourth test situation: t=160 minutes.
measure: Salivary oxytocin
timeFrame: 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
measure: Visual analogue scales measuring expected psychological and physiological effects of the test day including, including all four test situations
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
measure: Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately preceeding the first test situation: t=30 minutes
measure: Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately preceeding the second test situation: t= 70minutes
measure: Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately preceeding the third test situation: t= 110 minutes
measure: Visual analogue scales measuring expected psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately preceeding the fourth test situation: t=150 minutes
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately following the first test situations: t=40 minutes
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately following the second test situation: t= 80 minutes
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately following the third test situation: t=120 minutes
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the four test situations
timeFrame: Test periods: Measured immediately following the fourth test situation: t= 160 minutes
measure: Visual analogue scales measuring perceived psychological and physiological effects of of the test day including, including all four test situations
timeFrame: After last resting period: Measured at the end of the last resting period, following the last of the four test situations, t=190 minutes
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Test periods: Measured immediately following the first test situation: t=40 minutes
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Test periods: Measured immediately following the second test situation: t= 80 minutes
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Test periods: Measured immediately following the third test situation: t= 120 minutes
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Test periods: Measured immediately following the fourth test situation: t= 160 minutes
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceeding the first of the four test situations (t=0 minutes)
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Test periods: Measured immediately following the first test situation: t= 40 minutes
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Test periods: Measured immediately following the second test situation: t= 80 minutes
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Test periods: Measured immediately following the third test situation: t=120 minutes
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Test periods: Measured immediately following the fourth test situation: t=160 minutes
Secondary outcomes:
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 190 minutes (through the pre-intervention period, the four test situations and all resting periods)
Other outcomes:
Locations:
city: Tjele
country: Denmark
facility: Aarhus University
Study officials:
affiliation: Senior researcher
name: Karen Thodberg
role: PRINCIPAL_INVESTIGATOR
References: