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Clinical Trial 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.


Clinical Trial 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) ;


Study Design


NCT number NCT04866173
Study type Interventional
Source University of Aarhus
Contact Karen Thodberg, PhD
Phone 61687397
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 1, 2021
Completion date December 1, 2022