Clinical trial NCT06292390: The Effect Of Pet Therapy Applıed To Elders's Sleep And Qualıty Of Lıfe
Official title: The Effect Of Pet Therapy Applıed To Elderly Indıvıduals Lıvıng In A Nursıng Home On Sleep And Qualıty Of Lıfe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pet Therapy Effect of Sleep and Quality of Life
Keywords: poor quality of life
problems of sleeping
sleeplessness
pet therapy
nursing practices
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 59
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (Two groups with intervention and control group)
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

The universe of the research consists of 74 elderly elderly individuals who are located in a nursing home in Tokat province and meet the criteria for inclusion.

As a result of the calculations; the minimum sample volume that will provide the test power (1-β) = 0.95 was calculated as a total of 46 (23 interventions + 23 controls) people, and the net power of this study was determined as 0.952.

In the research, the data will be collected through the 'Elderly Person Introduction Form" CASP-19 Quality of Life Scale and PUKI sleep quality scale and Mini Mental Test (MMT). Since conducting the study double-blind will increase the reliability of the study, the application of the scales was applied by another researcher/surveyor other than the main researcher.

The Control Group Protocol:

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.

Intervention Group Protocol:

After the data collection process of the control group was completed, the data collection process of the intervention group and pet therapy were applied. As a result of literature review; there is no clear duration for pet therapy and it was found that the average activity duration was 10-30 minutes, 4-12 weeks and 6-24 sessions. Based on this literature information; for this research, pet therapy pet therapy was applied for a total of 6 weeks and 12 sessions, 2 times a week for an average of 20 minutes for each elderly individual. End of therapy 6.week rating and 10.the scale was applied three times in total, including control measurement after a week of therapy. The scales applied by the animal therapy researcher were collected by the face-to-face interview method by the interviewer who did not know the groups.

In the evaluation of data, IBM SPSS Statistics 25.0 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0.Armonk, NY: IBM Corp.) the statistical package program was used. The normal distribution of the data of numerical variables was evaluated by Shapiro-Wilk normality test/Kruskal Wallis test and Q-Q graphs. Spearman correlation analysis was performed to determine the relationship between the dimensions. Dec. Statistically, a value of p≤0.05 was considered significant.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PUKI
timeFrame: First week, the end of six week and end of ten week.
Secondary outcomes:
measure: CASP-19 QUALITY OF LIFE
timeFrame: First week, the end of six week and end of ten week.
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Nursing Home
state: Center
Study officials:
affiliation: https://www.gop.edu.tr/AkademikOzgecmis/6508/cansu-yilmaz
name: Cansu YILMAZ
role: PRINCIPAL_INVESTIGATOR
affiliation: https://avesis.erciyes.edu.tr/ptekinsoy
name: Pınar TEKINSOY KARTIN
role: STUDY_DIRECTOR
References: