Determining the effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes in Bojnord city
Design
Randomized, unblinded, randomized clinical trial on 40 elderly people using a table of random numbers for randomization.
Settings and conduct
12 laughter yoga sessions for 100 minutes are performed on 20 elderly people in three nursing homes in Bojnord city, which are selected using a table of random numbers. In this study, only the elderly people do not know their group.
Participants/Inclusion and exclusion criteria
Entry criteria: Completion of the informed consent form, the elderly must be residents of Bojnord 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 Bojnord city
Intervention groups
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
Main outcome variables
Significant change in the score of life expectancy and quality of life in the elderly in the intervention group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240123060777N2
Registration date:2024-07-19, 1403/04/29
Registration timing:prospective
Last update:2024-07-19, 1403/04/29
Update count:0
Registration date
2024-07-19, 1403/04/29
Registrant information
Name
Azam Saedikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 574 6207
Email address
a.saedikia@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes
Public title
The effect of laughter yoga on the quality and life expectancy of elderly people living in nursing homes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Complete the informed consent form
Elderly residents of Bojnord 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 Bojnoord city
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
South side of Imam Ali Hospital (AS), Shahriar St, Bojnoord.
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.NKUMS.REC.1402.152
Health conditions studied
1
Description of health condition studied
Life expectancy and quality of life of the elderly.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Coefficient score in Schneider's life expectancy questionnaire
Timepoint
before the intervention and 1 week after the intervention
Method of measurement
Using Schneider's life expectancy questionnaire
2
Description
Coefficient score in Lipad elderly quality of life questionnaire
Timepoint
before the intervention and 1 week after the intervention
Method of measurement
Using Lipad elderly quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Lifestyle
2
Description
Control group: Random selection of 20 elderly people, filling out the questionnaires, not receiving laughter yoga sessions, filling out the questionnaires again.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Azarmehr nursing home
Full name of responsible person
Azam Alidadian
Street address
Dariush St, Esteghlal Blvd, Bojnord Town.
City
Bojnurd
Province
North Khorasan
Postal code
9461976199
Phone
+98 58 4222 9276
Email
nurse.saedikia@yahoo.com
2
Recruitment center
Name of recruitment center
Mehrana nursing home
Full name of responsible person
Azam Banihashem
Street address
Khayyam 4, Shahada Boulevard, Bojnord Town.
City
Bojnurd
Province
North Khorasan
Postal code
9461976199
Phone
+98 58 3622 9535
Email
nurse.saedikia@yahoo.com
3
Recruitment center
Name of recruitment center
Pardis nursing home
Full name of responsible person
Maryam Vahani
Street address
No. 20, Second alley on the left, After 32 meters from Shahrabazi, Bojnord Town.
City
Bojnord
Province
North Khorasan
Postal code
9416716953
Phone
+98 58 3622 9535
Email
nurse.saedikia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Bahram Bibak
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnord Town.
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 0000
Email
INFO@NKUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Azam Saedikia
Position
Faculty instructor
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Next to Social Security Organization, Imam Khomeini Boulevard, Shirvan Town, North Khorasan.
City
Shirvan
Province
North Khorasan
Postal code
74877-94149
Phone
+98 938 574 6207
Email
nurse.saedikia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Azam Saedikia
Position
Faculty instructor
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Next to Social Security Organization, Imam Khomeini Boulevard, Shirvan Town, North Khorasan.
City
Shirvan
Province
North Khorasan
Postal code
74877-94149
Phone
+98 938 574 6207
Email
nurse.saedikia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Azam Saedikia
Position
Faculty instructor
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Next to Social Security Organization, Imam Khomeini Boulevard, Shirvan, North Khorasan.
City
Shirvan
Province
North Khorasan
Postal code
74877-94149
Phone
+98 938 574 6207
Email
nurse.saedikia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be accessible through publication in reputable journals, but the names of the participants will not be mentioned
When the data will become available and for how long
Access starts 8 months after results are published
To whom data/document is available
Public
Under which criteria data/document could be used
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
From where data/document is obtainable
Corresponding author contact will be made available.
nurse.saedikia@yahoo.com Email
09385746207 Contact phone
9461976199 Postal code
05836229535 Contact phone
What processes are involved for a request to access data/document
All sufficient information will be available in the printed version. If you need more information, you can contact the responsible author through communication channels.