Pet Therapy Effect of Sleep and Quality of LifeNCT06292390
The Effect Of Pet Therapy Applıed To Elders's Sleep And Qualıty Of Lıfe
A study testing Pet Therapy in people with Pet Therapy Effect of Sleep and Quality of Life, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Pet Therapy Effect of Sleep and Quality of Life
- What is being tested?
- Pet Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Pet Therapy Applıed To Elderly Indıvıduals Lıvıng In A Nursıng Home On Sleep And Qualıty Of Lıfe
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.
Read the 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.
- Being tested
- Pet Therapy
- Keywords
- poor quality of life, problems of sleeping, sleeplessness, pet therapy, nursing practices
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First week, the end of six week and end of ten week.
Secondary outcomes (1)
CASP-19 QUALITY OF LIFE
The CASP-19 scale was developed by Hyde et al. in 2003 to measure the quality of life of elderly people. The scale consists of 19 items. The items of the scale are scored between 0-3 points.Dec. An increase in the total score indicates an increase in the quality of life. As a result of the factor analysis conducted by Hyde et al. for structure validity, it was found that the scale consists of 4 sub-dimensions, the Cronbach's alpha values of each sub-dimension are between 0. Dec.9-Dec.77, the item total score correlation coefficients are between r= 0.35 and r= 0.67.
Measured: First week, the end of six week and end of ten week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 Nov 2021
- Primary completion12 May 2022
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pet Therapy Effect of Sleep and Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (Two groups with intervention and control group)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Yilmaz, Tokat Gaziosmanpasa University
- Investigators
- Cansu YILMAZ, Principal investigator, https://www.gop.edu.tr/AkademikOzgecmis/6508/cansu-yilmazPınar TEKINSOY KARTIN, Study director, https://avesis.erciyes.edu.tr/ptekinsoy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292390
- Sponsor's protocol ID
- AIBU-SBF-CY-09
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Pet Therapy Applıed To Elderly Indıvıduals Lıvıng In A Nursıng Home On Sleep And Qualıty Of Lıfe
- ClinicalTrials.gov ID
- NCT06292390
- Acronym / sponsor ID
- AIBU-SBF-CY-09
- Keywords
- poor quality of life, problems of sleeping, sleeplessness, pet therapy, nursing practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial (Two groups with intervention and control group)
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Pet TherapyPet 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. |
| 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pet TherapyPet 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. | Other | Intervention Group |
Primary outcome
PUKI
Time frame: First week, the end of six week and end of ten week.
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.
1 secondary outcome
CASP-19 QUALITY OF LIFE
Time frame: First week, the end of six week and end of ten week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cansu YILMAZ principal investigator
https://www.gop.edu.tr/AkademikOzgecmis/6508/cansu-yilmaz
Pınar TEKINSOY KARTIN study director
https://avesis.erciyes.edu.tr/ptekinsoy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pet Therapy in people with Pet Therapy Effect of Sleep and Quality of Life, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PUKI (time frame: First week, the end of six week and end of ten week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.