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Effects of Contact to Dogs During Stressful Situations

Not Applicable
Completed
Conditions
Physiological Stress Responses to Standardises Stress Situations
Behavioural Responses to Standardised Stress Situations
Psychological Responses to Standardised Stress Situations
Interventions
Other: Dog
Other: No Dog
Registration Number
NCT04866173
Lead Sponsor
University of Aarhus
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)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DogDogBeing subjected to two standardised stress situations with a dog and its handler present
No DogNo DogBeing subjected to two standardised stress situations without a dog present, but in the presence of a person (dog handler)
Primary Outcome Measures
NameTimeMethod
Physiological measure, heart rateMeasured 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)]

The test person wears self-adhesive electrodes and the heart rate is measured non-invasively

Physiological measure, systolic and diastolic blood pressureMeasured after Rest period 4 (t=174 minutes)]

Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff.

Physiological measure, heart rate variabilityMeasured 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)]

Heart rate variability is calculated from heart rate data.

Galvanic skin responseMeasured 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)]

The test person is fitted with electrodes on two fingers and galvanic skin response is measured non-invasively.

Salivary cortisolMeasured 40 minutes after MAST test (t=174 minutes)]

Saliva is obtained from the test subject with a cotton swab which is chewed for one minute

Visual analogue scales measuring expected psychological and physiological effects of the test day including, including the two test situation and the rest periodsBaseline: Measured at onset of the 30 minute pre-intervention period (t=0 minutes)]

Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

Visual analogue scales measuring expected psychological and physiological effects of the two test situations: Measured immediately preceding MAST test (t=119 minutes]

Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

Visual analogue scales measuring perceived psychological and physiological effects of each of the two test situationsMeasured immediately following MAST test 1 (t=134 minutes)

Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

Visual analogue scales measuring perceived psychological and physiological effects of of the test day including the test situations and rest periodMeasured immediately after Rest period 4 (t=174 minutes)

Test persons fill in a visual analogue scale. Minimum value -100 (very negative effect) and maximum value 100 (very positive effect), and 0 being neutral.

The State-Trait Anxiety Inventory (STAI)Measured immediately after Rest period 4 (t=174 minutes)

State anxiety is measured with the STAI-scale (minimum score= 20, maximum score= 80, and a lower score indicates a high anxiety level)

The Positive and Negative Affect Schedule (PANAS)Measured immediately after Rest period 4 (t=174 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.

Quantitative behavioural measures - frequencies of behavioural elementsMeasured 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)]

A video recording of the test persons behaviour is analysed for frequency of talking to the dog (Only in the arm: Dog).

Quantitative behavioural measures - duration of behavioural elementsMeasured 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)]

A video recording of the test persons behaviour is analysed for the duration (seconds) of talking to the dog (Only in the arm: Dog).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Aarhus University

🇩🇰

Tjele, Denmark

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