NCT06292390

Brief Summary

Quality of life is defined as functional abilities that include the ability to fulfill an individual social role, the degree and quality of social interaction, mental health, physical competence, somatic senses such as pain, and satisfaction with life. The World Health Organization (WHO) defined quality of life in 1947 as a decrease not only in disease, disorder or disability, but also in physical, mental and social well-being. Old age is one of the situations in which the quality of life decreases. It is reported that the poor social and financial situation of individuals, low educational level, gender, lack of physical movement, decreased daily life activity level, decreased mobility ability, fall anxiety, sleep problems and other conditions that cause disability are determinants of the quality of life. According to the results of Bloom et al.'s study, elderly people wake up at night due to health problems. According to the literature, the sleep and life of pet therapy applied to elderly individuals living in a nursing home there have not been any studies examining the effect on quality. For this reason, it was aimed to conduct this study in order to determine the effect of pet therapy applied to elderly individuals living in a nursing home on sleep and quality of life. The study was planned to be conducted in a randomized controlled manner in order to determine the effect of pet therapy applied for one hour twice a week for 6 weeks to elderly people living in a nursing home in Tokat province on sleep pattern and quality of life. In the study, gender, age group and the presence of chronic diseases were taken as equivalence criteria. Since conducting the study single-blind will increase the reliability of the study, the application of the scales was applied by another researcher/surveyor other than the main researcher.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

February 27, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

poor quality of lifeproblems of sleepingsleeplessnesspet therapynursing practices

Outcome Measures

Primary Outcomes (1)

  • PUKI

    PUKI was developed by Buysse et al. in 1989 and has been shown to have sufficient internal consistency (Cronbach alpha= 0.80), test-retest reliability and validity (Buysse Reynolds Monk Berman and Kupfer 1989). The validity and reliability study of PUKI in our country was conducted by Ağargün et al. In this study, the Cronbach alpha value of the scale was found to be 0.79 (Cronbach alpha= 0.79). The total score has a value between 0-21.Dec. High values indicate that the quality of sleep is poor, the level of sleep disorders is high. A total score above 5 indicates that sleep quality is clinically poor.

    First week, the end of six week and end of ten week.

Secondary Outcomes (1)

  • CASP-19 QUALITY OF LIFE

    First week, the end of six week and end of ten week.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Pet therapy was applied to the individuals in the intervention group for 6 weeks in addition to their normal routine lives. This therapy was applied every 20 minutes, 2 days a week. Repeated measurements were made before therapy, at the end of therapy and 4 weeks after the end of therapy. The scales were collected by the questionnaire by face-to-face interview method.

Other: Pet Therapy

Control Group

NO INTERVENTION

The elderly in this group have not been given any treatment, they have received routine nursing home care and necessary treatments if any. The first evaluation of the elderly in the control group, 6.week and 10.the necessary measurements were made with the scales three times a week in total. The scales were collected by the questionnaire by face-to-face interview method.

Interventions

Pet therapy was applied to the individuals in the intervention group for 6 weeks in addition to their normal routine lives. This therapy was applied every 20 minutes, 2 days a week. Repeated measurements were made before therapy, at the end of therapy and 4 weeks after the end of therapy.

Intervention Group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tokat- Living in a nursing home,
  • According to expert opinion, elderly people who received a minimum of 24 points in Mini Mental Test assessments,
  • Able to communicate,
  • Those who are not immobile and able to do activities with a dog,
  • Not allergic to a dog,
  • Not having a phobia of dogs,
  • Sedative / antisedative, insomnia / hypersomnia,
  • Elderly who agreed to participate in the study

You may not qualify if:

  • People who are immobile and unable to do activities with the dog,
  • Individuals who cannot communicate,
  • (According to expert view)Those who score below 24 points of Mini Mental Test,
  • Those who are allergic to dogs,
  • Those who have a phobia of dogs,
  • Those who use medications that will affect sleep processes, such as sedatives /antisedatives, insomnia/hypersomnia,
  • People who do not want to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing Home

Tokat Province, Center, 60000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Cansu YILMAZ

    https://www.gop.edu.tr/AkademikOzgecmis/6508/cansu-yilmaz

    PRINCIPAL INVESTIGATOR
  • Pınar TEKINSOY KARTIN

    https://avesis.erciyes.edu.tr/ptekinsoy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A pollster who did not know the people in the control and intervention group was selected and collected the data. The SPSS data were entered by someone selected other than the surveyor and the researcher. Thus, the study was conducted as a double-blind.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial (Two groups with intervention and control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 5, 2024

Study Start

November 15, 2021

Primary Completion

May 12, 2022

Study Completion

June 22, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations