Behavioural and Physiological Responses to Dog Visits in Nursing Homes

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05516264
Collaborator
(none)
50
1
2
15.8
3.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dog visits/control visits
  • Behavioral: Control visits/dog visits
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants from 2 nursing homes (25+25) are all receive three visit with a dog and three without a dog. It is randomised whter participents receive the dog visits first or last.Participants from 2 nursing homes (25+25) are all receive three visit with a dog and three without a dog. It is randomised whter participents receive the dog visits first or last.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Behavioural and Physiological Responses to Dog Visits in Nursing Homes
Anticipated Study Start Date :
Sep 5, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Dog visits first

Participants receive the three dogs visits first and then, after a break, receive the three control visits

Behavioral: Dog visits/control visits
See arm description above

Other: Control visits first

Participants receive the three control visits first and then, after a break, receive the three dog visits

Behavioral: Control visits/dog visits
See arm description above

Outcome Measures

Primary Outcome Measures

  1. Heart rate [During visit no. 1, from 30 minutes before the visit to 30 minutes after]

    The test person wears a device placed on the upper arm

  2. Heart rate [During visit no. 2, from 30 minutes before the visit to 30 minutes after]

    The test person wears a device placed on the upper arm

  3. Heart rate [During visit no. 3, from 30 minutes before the visit to 30 minutes after]

    The test person wears a device placed on the upper arm

  4. Heart rate [During visit no. 4, from 30 minutes before the visit to 30 minutes after]

    The test person wears a device placed on the upper arm

  5. Heart rate [During visit no. 5, from 30 minutes before the visit to 30 minutes after]

    The test person wears a device placed on the upper arm

  6. Heart rate [During visit no. 6, from 30 minutes before the visit to 30 minutes after]

    The test person wears a device placed on the upper arm

  7. Heart rate variability [During visit no. 1, from 30 minutes before the visit to 30 minutes after]

    Heart rate variability is calculated from heart rate data

  8. Heart rate variability [During visit no. 2, from 30 minutes before the visit to 30 minutes after]

    Heart rate variability is calculated from heart rate data

  9. Heart rate variability [During visit no. 3, from 30 minutes before the visit to 30 minutes after]

    Heart rate variability is calculated from heart rate data

  10. Heart rate variability [During visit no. 4, from 30 minutes before the visit to 30 minutes after]

    Heart rate variability is calculated from heart rate data

  11. Heart rate variability [During visit no. 5, from 30 minutes before the visit to 30 minutes after]

    Heart rate variability is calculated from heart rate data

  12. Heart rate variability [During visit no. 6, from 30 minutes before the visit to 30 minutes after]

    Heart rate variability is calculated from heart rate data

  13. Behaviour during visits [During visit no. 1, from 30 minutes before the visit to 30 minutes after]

    The test persons behaviour is observed

  14. Behaviour during visits [During visit no. 2, from 30 minutes before the visit to 30 minutes after]

    The test persons behaviour is observed

  15. Behaviour during visits [During visit no. 3, from 30 minutes before the visit to 30 minutes after]

    The test persons behaviour is observed

  16. Behaviour during visits [During visit no. 4, from 30 minutes before the visit to 30 minutes after]

    The test persons behaviour is observed

  17. Behaviour during visits [During visit no. 5, from 30 minutes before the visit to 30 minutes after]

    The test persons behaviour is observed

  18. Behaviour during visits [During visit no. 6, from 30 minutes before the visit to 30 minutes after]

    The test persons behaviour is observed

  19. Salivary cortisol [Visit 1, 2 minutes before visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  20. Salivary cortisol [Visit 2, 2 minutes before visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  21. Salivary cortisol [Visit 3, 2 minutes before visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  22. Salivary cortisol [Visit 4, 2 minutes before visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  23. Salivary cortisol [Visit 5, 2 minutes before visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  24. Salivary cortisol [Visit 6, 2 minutes before visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  25. Salivary cortisol [Visit 1, 5 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  26. Salivary cortisol [Visit 2, 5 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  27. Salivary cortisol [Visit 3, 5 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  28. Salivary cortisol [Visit 4, 5 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  29. Salivary cortisol [Visit 5, 5 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  30. Salivary cortisol [Visit 6, 5 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  31. Salivary cortisol [Visit 1, 30 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  32. Salivary cortisol [Visit 2, 30 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  33. Salivary cortisol [Visit 3, 30 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  34. Salivary cortisol [Visit 4, 30 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  35. Salivary cortisol [Visit 5, 30 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

  36. Salivary cortisol [Visit 6, 30 minutes after visit]

    Saliva is obtained from the testperson with a swab which held his/her mouth for one minute

Secondary Outcome Measures

  1. The visitor's and observer's perception of how the visit was experienced by the test person. [5 minutes after visit 1]

    Minimum value 0 (worst possible visit) to 100 (best possible visit)

  2. The visitor's and observer's perception of how the visit was experienced by the test person. [5 minutes after visit 2]

    Minimum value 0 (worst possible visit) to 100 (best possible visit)

  3. The visitor's and observer's perception of how the visit was experienced by the test person. [5 minutes after visit 3]

    Minimum value 0 (worst possible visit) to 100 (best possible visit)

  4. The visitor's and observer's perception of how the visit was experienced by the test person. [5 minutes after visit 4]

    Minimum value 0 (worst possible visit) to 100 (best possible visit)

  5. The visitor's and observer's perception of how the visit was experienced by the test person. [5 minutes after visit 5]

    Minimum value 0 (worst possible visit) to 100 (best possible visit)

  6. The visitor's and observer's perception of how the visit was experienced by the test person. [5 minutes after visit 6]

    Minimum value 0 (worst possible visit) to 100 (best possible visit)

  7. Visual analoque scale of the testpersons' evaluation of the visit [5 minutes after visit 1]

    Minimum value 0 (worst possible experience) to 100 (best possible experience)

  8. Visual analoque scale of the testpersons' evaluation of the visit [5 minutes after visit 2]

    Minimum value 0 (worst possible experience) to 100 (best possible experience)

  9. Visual analoque scale of the testpersons' evaluation of the visit [5 minutes after visit 3]

    Minimum value 0 (worst possible experience) to 100 (best possible experience)

  10. Visual analoque scale of the testpersons' evaluation of the visit [5 minutes after visit 4]

    Minimum value 0 (worst possible experience) to 100 (best possible experience)

  11. Visual analoque scale of the testpersons' evaluation of the visit [5 minutes after visit 5]

    Minimum value 0 (worst possible experience) to 100 (best possible experience)

  12. Visual analoque scale of the testpersons' evaluation of the visit [5 minutes after visit 6]

    Minimum value 0 (worst possible experience) to 100 (best possible experience)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karen Thodberg Højslev Denmark 7840

Sponsors and Collaborators

  • University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT05516264
Other Study ID Numbers:
  • ANIMAL CONTACT 4
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus

Study Results

No Results Posted as of Aug 25, 2022