Clinical trial NCT04866173: Effects of Contact to Dogs During Stressful Situations
Official title: Effects of Contact to a Dog During Standardised Stressful Situations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress Responses to Standardises Stress Situations
Psychological Responses to Standardised Stress Situations
Behavioural Responses to Standardised Stress Situations
Keywords: Human-animal contact
Non-invasive measure
Animal-assisted contact
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will conduct an experimental study comparing responses of healthy participants in two test situations where they are subjected to mild stress. The study design is a randomised controlled crossover design nested within two groups - one with a dog present and another without a dog present. The participants will be randomly allocated to two groups (with dog and without dog) and the participants will receive both test situations on the same day. During the two test situations the participants will be subjected to a classical stress test , and exposed to tolerable pain, as well as periods with relaxation.

Detailed description: The study design is a randomised controlled crossover design, nested within two groups - one with a dog present (Dog) and another without a dog present (No Dog). Both groups will be subjected to a classical stress test - the Maastricht Acute Stress Test (MAST) and a pain test with periods of relaxation in between. The participants will be subjected to both test situations on the same day and in the same order.

On the test day, background information and baseline measures (baseline period, duration: 40 minutes) will be collected, whereafter the participants rest for 30 minutes (pre-intervention rest period). After this the participants are subjected to the two test situations, pain test (60 minutes, including calibration and two separate tests sessions) and MAST (15 minutes, including 5 min introduction) with 30 minutes of relaxation in between and a 40 min post-rest period The participants' interaction with the dog is recorded using quantitative behaviour sampling using predefined behavioural categories.

Most physiological and all behavioural measures are recorded continuously throughout test situations and relaxation, in order to be able to study the response to the stress situations and recovery, and the response to contact with dog, and to psychological responses. Some physiological measures obtained before and after each test situation.

Below the exact time schedule of the test day is shown and these times will be refered to when the outcome measures are described. The "Baseline period" (40 minutes) and the last 10 minutes where the equipment for physiological measures is removed is not included in the duration of the test period (174 minutes). All times are given in minutes.

Baseline period (40 minutes - not part of total test period)

* Pre-intervention period (start t = 0; end t = 30)
* Calibration for pain test (start t = 30, end t = 35)
* Rest period 1 (start t = 35, end t = 47)
* Pain test 1 (start t = 47, end t = 52)
* Post-pain test 1 (start t = 52, end, t= 62)
* Rest period 2 (start t = 62, end t = 74)
* Pain test 2 (start t = 74, end t = 79)
* Post-pain test 2 (start t = 79, end t = 89)
* Rest period 3 (start t = 89, end t = 119)
* MAST test (incl. introduction (start t = 119, end t = 134)
* Rest period 4 (start t = 134, end t = 174)

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 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured at the end of the 30 minute pre-intervention period (t=30 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured at the end of Rest Period 1 (t=47 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured after Pain test 1 (t=52 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured at the end of Rest period 2 (t=74 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured after Pain test 2 (t=79 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured at the end of Rest period 3 (t=119 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured after MAST test (t=134 minutes)]
measure: Physiological measure, systolic and diastolic blood pressure
timeFrame: Measured after Rest period 4 (t=174 minutes)]
measure: Physiological measure, heart rate variability
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Galvanic skin response
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Salivary cortisol
timeFrame: Measured at the end of the 30 minute pre-intervention period (t=30 minutes)]
measure: Salivary cortisol
timeFrame: Measured at the end of Rest Period 1 (t=47 minutes)]
measure: Salivary cortisol
timeFrame: Measured after Post-pain test 1 (t=62 minutes)]
measure: Salivary cortisol
timeFrame: Measured at the end of Rest period 2 (t=74 minutes)]
measure: Salivary cortisol
timeFrame: Measured after Post-pain test 2 (t=89 minutes)]
measure: Salivary cortisol
timeFrame: Measured at the end of Rest period 3 (t=119 minutes)]
measure: Salivary cortisol
timeFrame: Measured after MAST test (t=134 minutes)]
measure: Salivary cortisol
timeFrame: Measured 5 minutes after MAST test (t=139 minutes)]
measure: Salivary cortisol
timeFrame: Measured 10 minutes after MAST test (t=144 minutes)]
measure: Salivary cortisol
timeFrame: Measured 20 minutes after MAST test (t=154 minutes)]
measure: Salivary cortisol
timeFrame: Measured 30 minutes after MAST test (t=164 minutes)]
measure: Salivary cortisol
timeFrame: Measured 40 minutes after MAST test (t=174 minutes)]
measure: Visual analogue scales measuring expected psychological and physiological effects of the test day including, including the two test situation and the rest periods
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period (t=0 minutes)]
measure: Visual analogue scales measuring expected psychological and physiological effects of the two test situations
timeFrame: : Measured immediately preceding Pain test 1 (t=47 minutes]
measure: Visual analogue scales measuring expected psychological and physiological effects of the two test situations
timeFrame: : Measured immediately preceding Pain test 2 (t=74 minutes]
measure: Visual analogue scales measuring expected psychological and physiological effects of the two test situations
timeFrame: : Measured immediately preceding MAST test (t=119 minutes]
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations
timeFrame: Measured immediately following Pain test 1(t=52 minutes)
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations
timeFrame: Measured immediately following Pain test 2 (t=79 minutes)
measure: Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situations
timeFrame: Measured immediately following MAST test 1 (t=134 minutes)
measure: Visual analogue scales measuring perceived psychological and physiological effects of of the test day including the test situations and rest period
timeFrame: Measured immediately after Rest period 4 (t=174 minutes)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceding the first test situation (t=0 minutes)]
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Measured immediately following Pain test 1 (t= 52 minutes)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Measured immediately following Pain test 2 (t= 79 minutes)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Measured immediately following MAST test 1 (t=134 minutes)
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Measured immediately after Rest period 4 (t=174 minutes)
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline: Measured at onset of the 30 minute pre-intervention period preceding the first test situation (t=0 minutes)]
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Measured immediately following Pain test 1 (t= 52 minutes)
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Measured immediately following Pain test 2 (t= 79 minutes)
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Measured immediately following MAST test 1 (t=134 minutes)
measure: The Positive and Negative Affect Schedule (PANAS)
timeFrame: Measured immediately after Rest period 4 (t=174 minutes)
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - frequencies of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
measure: Quantitative behavioural measures - duration of behavioural elements
timeFrame: Measured continuously throughout the total test period of 174 minutes (starting in the pre-intervention period and during the following test situations and all resting periods)]
Secondary outcomes:
Other outcomes:
Locations:
city: Tjele
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Karen Thodberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: