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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05516264
Other study ID # ANIMAL CONTACT 4
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 5, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural measurements to quantity the activity and the actual amount and intensity of contact to the dog.


Description:

The residents will receive six 10-minute visits, three visits with a dog and three without a dog, with a week-long break in between the two visit types. The participants will be randomly assigned to receive either the three dog visits or the three visits without a dog first. The visits will be from the same person, and the dog visits will be accompanied with the same dog each time. During dog visits, the dog will be available for touch, and the resident will be encouraged to interact with the dog. Before each visit the resident is fitted with the equipment for measuring continuously recorded physiological measures and then relaxes for 30 minutes. Immediately before and five and 30 minutes after each visit, the investigators obtain a saliva sample to detect cortisol levels. The behaviour of the participants will be video recorded during the visits to quantify the frequency and duration of predefined behavioural elements, using ethological methodology. The investigators will quantify the participants' activity during the visits as well as the frequency and duration of tactile contact with the dog, and verbal communication with the dog and the visitor. In addition, the visitor and the observer present during the visit will subjectively assess the resident's perception of the visit.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age of 65 years or more - Able to sit during visits (either in a chair or in a bed) Exclusion Criteria: - Known allergy to dogs - Known fear of dogs

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dog visits/control visits
See arm description above
Control visits/dog visits
See arm description above

Locations

Country Name City State
Denmark Karen Thodberg Højslev

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart rate The test person wears a device placed on the upper arm During visit no. 1, from 30 minutes before the visit to 30 minutes after
Primary Heart rate The test person wears a device placed on the upper arm During visit no. 2, from 30 minutes before the visit to 30 minutes after
Primary Heart rate The test person wears a device placed on the upper arm During visit no. 3, from 30 minutes before the visit to 30 minutes after
Primary Heart rate The test person wears a device placed on the upper arm During visit no. 4, from 30 minutes before the visit to 30 minutes after
Primary Heart rate The test person wears a device placed on the upper arm During visit no. 5, from 30 minutes before the visit to 30 minutes after
Primary Heart rate The test person wears a device placed on the upper arm During visit no. 6, from 30 minutes before the visit to 30 minutes after
Primary Heart rate variability Heart rate variability is calculated from heart rate data During visit no. 1, from 30 minutes before the visit to 30 minutes after
Primary Heart rate variability Heart rate variability is calculated from heart rate data During visit no. 2, from 30 minutes before the visit to 30 minutes after
Primary Heart rate variability Heart rate variability is calculated from heart rate data During visit no. 3, from 30 minutes before the visit to 30 minutes after
Primary Heart rate variability Heart rate variability is calculated from heart rate data During visit no. 4, from 30 minutes before the visit to 30 minutes after
Primary Heart rate variability Heart rate variability is calculated from heart rate data During visit no. 5, from 30 minutes before the visit to 30 minutes after
Primary Heart rate variability Heart rate variability is calculated from heart rate data During visit no. 6, from 30 minutes before the visit to 30 minutes after
Primary Behaviour during visits The test persons behaviour is observed During visit no. 1, from 30 minutes before the visit to 30 minutes after
Primary Behaviour during visits The test persons behaviour is observed During visit no. 2, from 30 minutes before the visit to 30 minutes after
Primary Behaviour during visits The test persons behaviour is observed During visit no. 3, from 30 minutes before the visit to 30 minutes after
Primary Behaviour during visits The test persons behaviour is observed During visit no. 4, from 30 minutes before the visit to 30 minutes after
Primary Behaviour during visits The test persons behaviour is observed During visit no. 5, from 30 minutes before the visit to 30 minutes after
Primary Behaviour during visits The test persons behaviour is observed During visit no. 6, from 30 minutes before the visit to 30 minutes after
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 1, 2 minutes before visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 2, 2 minutes before visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 3, 2 minutes before visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 4, 2 minutes before visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 5, 2 minutes before visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 6, 2 minutes before visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 1, 5 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 2, 5 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 3, 5 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 4, 5 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 5, 5 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 6, 5 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 1, 30 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 2, 30 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 3, 30 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 4, 30 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 5, 30 minutes after visit
Primary Salivary cortisol Saliva is obtained from the testperson with a swab which held his/her mouth for one minute Visit 6, 30 minutes after visit
Secondary The visitor's and observer's perception of how the visit was experienced by the test person. Minimum value 0 (worst possible visit) to 100 (best possible visit) 5 minutes after visit 1
Secondary The visitor's and observer's perception of how the visit was experienced by the test person. Minimum value 0 (worst possible visit) to 100 (best possible visit) 5 minutes after visit 2
Secondary The visitor's and observer's perception of how the visit was experienced by the test person. Minimum value 0 (worst possible visit) to 100 (best possible visit) 5 minutes after visit 3
Secondary The visitor's and observer's perception of how the visit was experienced by the test person. Minimum value 0 (worst possible visit) to 100 (best possible visit) 5 minutes after visit 4
Secondary The visitor's and observer's perception of how the visit was experienced by the test person. Minimum value 0 (worst possible visit) to 100 (best possible visit) 5 minutes after visit 5
Secondary The visitor's and observer's perception of how the visit was experienced by the test person. Minimum value 0 (worst possible visit) to 100 (best possible visit) 5 minutes after visit 6
Secondary Visual analoque scale of the testpersons' evaluation of the visit Minimum value 0 (worst possible experience) to 100 (best possible experience) 5 minutes after visit 1
Secondary Visual analoque scale of the testpersons' evaluation of the visit Minimum value 0 (worst possible experience) to 100 (best possible experience) 5 minutes after visit 2
Secondary Visual analoque scale of the testpersons' evaluation of the visit Minimum value 0 (worst possible experience) to 100 (best possible experience) 5 minutes after visit 3
Secondary Visual analoque scale of the testpersons' evaluation of the visit Minimum value 0 (worst possible experience) to 100 (best possible experience) 5 minutes after visit 4
Secondary Visual analoque scale of the testpersons' evaluation of the visit Minimum value 0 (worst possible experience) to 100 (best possible experience) 5 minutes after visit 5
Secondary Visual analoque scale of the testpersons' evaluation of the visit Minimum value 0 (worst possible experience) to 100 (best possible experience) 5 minutes after visit 6
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