Protocol summary
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Study aim
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Determining the effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes in Shirvan city
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Design
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Randomized, unblinded, randomized clinical trial on 40 elderly people using a table of random numbers for randomization.
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Settings and conduct
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12 laughter yoga sessions for 100 minutes are performed on 20 elderly people in two nursing homes in Shirvan city, which are selected using a table of random numbers. In this study, only the elderly people do not know their group.
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Participants/Inclusion and exclusion criteria
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Entry criteria: Completion of the informed consent form, the elderly must be residents of Shirvan nursing homes - the birth certificate age of the person is over 60 years old - without severe and chronic physical and mental illness based on the medical record - able to communicate with others - free of disorders Hearing and speech impair communication - no dementia or severe disability
Exclusion criteria:Participating in Laughter Yoga sessions in advance - Severe memory loss - Dissatisfaction in participating in Laughter Yoga training sessions, must not be a resident of an old people's home, must not be a resident of Shirvan city
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Intervention groups
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Completing Schneider's life expectancy and Lipad quality of life questionnaires in both intervention and control groups, teaching laughter yoga to the elderly participating in the intervention group
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Main outcome variables
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Significant change in the score of life expectancy and quality of life in the elderly in the intervention group
General information
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Reason for update
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Changing the study location from the Bojnurd nursing home to Shirvan.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240123060777N2
Registration date:
2024-07-19, 1403/04/29
Registration timing:
prospective
Last update:
2026-08-20, 1405/05/29
Update count:
1
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Registration date
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2024-07-19, 1403/04/29
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Registrant information
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Recruitment status
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Not yet recruiting
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Funding source
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Expected recruitment start date
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2026-10-23, 1405/08/01
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Expected recruitment end date
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2026-12-22, 1405/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes
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Public title
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The effect of laughter yoga on the quality and life expectancy of elderly people living in nursing homes
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Complete the informed consent form
Elderly residents of Shirvan city nursing homes
The birth certificate age of people is over 60 years old
Without severe and chronic physical and mental illness based on the medical record
Able to communicate with others
Have no hearing and speech disorders disrupting communication
Not having dementia or severe disability
Exclusion criteria:
Participate in Laughter Yoga sessions beforehand
Severe memory loss
Do not live in a nursing home
Not a resident of Shirvan city
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Age
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From 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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People will be randomly divided into two control groups (20 people) and intervention group (20 people). In this way, closed envelopes will be used for random allocation. Participants choose one envelope from among the 40 envelopes in the box, 20 of which contain the "A" card and the other 20 envelopes contain the "B" card. If they take the "A" card, they will be in the intervention group, and if they take the "B" card, they will be in the control group
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-29, 1402/09/08
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Ethics committee reference number
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IR.NKUMS.REC.1402.152
Health conditions studied
1
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Description of health condition studied
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Life expectancy and quality of life of the elderly.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Coefficient score in Schneider's life expectancy questionnaire
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Timepoint
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before the intervention and 1 week after the intervention
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Method of measurement
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Using Schneider's life expectancy questionnaire
2
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Description
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Coefficient score in Lipad elderly quality of life questionnaire
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Timepoint
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before the intervention and 1 week after the intervention
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Method of measurement
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Using Lipad elderly quality of life questionnaire
Intervention groups
1
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Description
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Intervention group: 20 elderly people will randomly receive 12 sessions for 100 minutes of laughter yoga training in North Khorasan nursing homes by a psychologist. The objectives and topics of the sessions will be as follows: First session: Getting to know the elderly; 2. Familiarizing the elderly with the benefits of laughter; 3. Introducing each participant and laughing at the one who introduces himself; 4. Handshake and warming, laughter and congratulations; 5. Greetings in Hindi (Namaste), and shake hands; and 6. Meditation and relaxation with positive and motivational words. The second session: laughing and congratulating; 2. Talking about the previous meeting; 3. Holding hands and warming up; 4. Deep breathing; 5. laughter of reasoning; 6. Forgiveness of laughter; 7. Appreciate laughter; 8. Show a movie; 9. Reading comic books; 10. meditation and relaxation. The third session: 1. Laughing and congratulating; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Cell phone laughter; 5. Japanese greeting; 6. A moment of laughter; 7. Showing a movie; 8. Reading a comic book; 9. meditation and relaxation. The fourth session: 1. exercise and stretching; 2. Laughing and congratulating; 3. Talking about previous meetings; 4. Hand grip and heating; 5. Rhythmic sounds and movements; 6. Shy laugh; 7. Cell phone laughter; 8. Show a movie; 9. Reading a comic book; 10. Meditation and relaxation, the fifth session: 1. laughing and congratulating; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Appreciate laughter; 5. Laughter of one meter; 6. Showing a movie; 7. Reading a comic book; 8. meditation and relaxation. The sixth session: 1. laughing and congratulating; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Deep breathing; 5. Lion's laugh; 6. Loud laughter; 7. Showing a movie; 8. Reading a comic book; 9. meditation and relaxation. The seventh session: 1. laughter and congratulations; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Laughter Seesaw; 5. Bicycle laughter; 6. Happy laughter; 7. Showing a movie; 8. Reading a comic book; 9. Meditation and relaxation. Eighth session: 1. Laughter and congratulations; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Argument of laughter; 5. Laughter 6. Joyful laughter; 7. Showing a movie; 8. Reading a comic book; 9. meditation and relaxation. The ninth session: 1. laughter and congratulations; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Appreciate laughter; 5. Rhythmic sounds and movements; 6. Loud laughter; 7. Showing a movie; 8. Reading a comic book; 9. meditation and relaxation. Tenth session: 1. laughter and congratulations; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Deep breathing; 5. Laughter of gratitude; 6. Japanese greeting; 7. Showing a movie; 8. Reading a comic book; 9. Meditation and relaxation of the 11th session: 1. laughter and congratulations; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Deep breathing; 5. Bicycle laughter; 6. Forgiveness of laughter; 7. Showing a movie; 8. Reading a comic book; 9. meditation and relaxation. 12th session: 1. Laughter and congratulations; 2. Talking about previous meetings; 3. Holding hands and warming up; 4. Deep breathing; 5. Loud laughter; 6. Happy laughter; 7. Showing a movie; 8. Reading a comic book; 9. Meditation
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Category
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Lifestyle
2
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Description
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Control group: Random selection of 20 elderly people, filling out the questionnaires, not receiving laughter yoga sessions, filling out the questionnaires again.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bojnourd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The data will be accessible through publication in reputable journals, but the names of the participants will not be mentioned
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When the data will become available and for how long
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Access starts 8 months after results are published
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To whom data/document is available
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Public
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Under which criteria data/document could be used
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If the researchers need to receive more information from the research, they can submit their request through the responsible author's email, and the requests will be made within the ethical framework. are realized
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From where data/document is obtainable
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Corresponding author contact will be made available.
nurse.saedikia@yahoo.com Email
09385746207 Contact phone
9461976199 Postal code
05836229535 Contact phone
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What processes are involved for a request to access data/document
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All sufficient information will be available in the printed version. If you need more information, you can contact the responsible author through communication channels.
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Comments
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