NCT05516264

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

August 19, 2022

Last Update Submit

May 7, 2024

Conditions

Physiological ResponsesBehaviorMood

Keywords

Human-animal contactNon-invasive measure

Outcome Measures

Primary Outcomes (36)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Behaviour during visits

    The test persons behaviour is observed

    During visit no. 1, from 30 minutes before the visit to 30 minutes after

  • Behaviour during visits

    The test persons behaviour is observed

    During visit no. 2, from 30 minutes before the visit to 30 minutes after

  • Behaviour during visits

    The test persons behaviour is observed

    During visit no. 3, from 30 minutes before the visit to 30 minutes after

  • Behaviour during visits

    The test persons behaviour is observed

    During visit no. 4, from 30 minutes before the visit to 30 minutes after

  • Behaviour during visits

    The test persons behaviour is observed

    During visit no. 5, from 30 minutes before the visit to 30 minutes after

  • Behaviour during visits

    The test persons behaviour is observed

    During visit no. 6, from 30 minutes before the visit to 30 minutes after

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (12)

  • The visitor's and observer's perception of how the visit was experienced by the test person.

    5 minutes after visit 1

  • The visitor's and observer's perception of how the visit was experienced by the test person.

    5 minutes after visit 2

  • The visitor's and observer's perception of how the visit was experienced by the test person.

    5 minutes after visit 3

  • The visitor's and observer's perception of how the visit was experienced by the test person.

    5 minutes after visit 4

  • The visitor's and observer's perception of how the visit was experienced by the test person.

    5 minutes after visit 5

  • +7 more secondary outcomes

Study Arms (2)

Dog visits first

OTHER

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

Behavioral: Dog visits/control visits

Control visits first

OTHER

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

Behavioral: Control visits/dog visits

Interventions

Dog visits/control visitsBEHAVIORAL

See arm description above

Dog visits first
Control visits/dog visitsBEHAVIORAL

See arm description above

Control visits first

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age of 65 years or more
  • Able to sit during visits (either in a chair or in a bed)

You may not qualify if:

  • Known allergy to dogs
  • Known fear of dogs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karen Thodberg

Højslev, 7840, Denmark

Location

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 25, 2022

Study Start

September 5, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

May 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)