History
# Registration date Revision Id
2 2026-08-17, 1405/05/26 392057
1 2024-07-19, 1403/04/29 308476
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    Determining the effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes in Bojnord city
    Determining the effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes in Shirvan city
    تعیین اثربخشی آموزش یوگای خنده بر کیفیت و امید به زندگی در سالمندان مقیم خانه های سالمندان شهرستان بجنورد
    تعیین اثربخشی آموزش یوگای خنده بر کیفیت و امید به زندگی در سالمندان مقیم خانه های سالمندان شهرستان شیروان
    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.
    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.
    جلسات یوگای خنده به تعداد12 جلسه به مدت 100 دقیقه بر روی 20 سالمند که در سه خانه سالمند در شهرستان بجنورد که با استفاده از جدول اعداد تصادفی انتخاب می شوند اجرا می شود در این مطالعه صرفا سالمندان از گروه خود اطلاع ندارند.
    جلسات یوگای خنده به تعداد12 جلسه به مدت 100 دقیقه بر روی 20 سالمند که در دو خانه سالمند در شهرستان شیروان که با استفاده از جدول اعداد تصادفی انتخاب می شوند اجرا می شود در این مطالعه صرفا سالمندان از گروه خود اطلاع ندارند.
    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
    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
    معیارهای ورود: تکمیل فرم رضایت آگاهانه ، سالمندان مقیم خانه های سالمندان شهرستان بجنورد باشند-سن شناسنامه ای افراد بالای ۶۰ سال باشد -بدون بیماری شدید و مزمن فیزیکی و روانی براساس پرونده ی پزشکی باشد- قادر به برقراری ارتباط با دیگران باشد- فاقد اختلالات شنوایی و گفتاری مختل کننده ارتباط باشد- عدم داشتن زوال عقل یا ناتوانی شدید معیار های خروج: شرکت در جلسات یوگای خنده از قبل- از دست دادن شدید حافظه- عدم رضایت در شرکت در جلسات آموزش یوگای خنده، مقیم خانه سالمندان نباشد، ساکن شهر بجنورد نباشند
    معیارهای ورود: تکمیل فرم رضایت آگاهانه ، سالمندان مقیم خانه های سالمندان شهرستان شیروان باشند-سن شناسنامه ای افراد بالای ۶۰ سال باشد -بدون بیماری شدید و مزمن فیزیکی و روانی براساس پرونده ی پزشکی باشد- قادر به برقراری ارتباط با دیگران باشد- فاقد اختلالات شنوایی و گفتاری مختل کننده ارتباط باشد- عدم داشتن زوال عقل یا ناتوانی شدید معیار های خروج: شرکت در جلسات یوگای خنده از قبل- از دست دادن شدید حافظه- عدم رضایت در شرکت در جلسات آموزش یوگای خنده، مقیم خانه سالمندان نباشد، ساکن شهر شیروان نباشند
  • General information

    2024-07-21, 1403/04/31
    2026-10-23, 1405/08/01
    2024-09-21, 1403/06/31
    2026-12-22, 1405/10/01
    empty
    Changing the study location from the Bojnurd nursing home to Shirvan.
    empty
    تغییر مکان مورد مطالعه از خانه سالمندان بجنورد به شیروان
    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
    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
    تکمیل فرم رضایت آگاهانه
    سالمندان مقیم خانه های سالمندان شهرستان بجنورد باشند
    سن شناسنامه ای افراد بالای ۶۰ سال باشد
    بدون بیماری شدید و مزمن فیزیکی و روانی براساس پرونده ی پزشکی باشد
    قادر به برقراری ارتباط با دیگران باشد
    فاقد اختلالات شنوایی و گفتاری مختل کننده ارتباط باشد
    عدم داشتن زوال عقل یا ناتوانی شدید
    تکمیل فرم رضایت آگاهانه
    سالمندان مقیم خانه های سالمندان شهرستان شیروان باشند
    سن شناسنامه ای افراد بالای ۶۰ سال باشد
    بدون بیماری شدید و مزمن فیزیکی و روانی براساس پرونده ی پزشکی باشد
    قادر به برقراری ارتباط با دیگران باشد
    فاقد اختلالات شنوایی و گفتاری مختل کننده ارتباط باشد
    عدم داشتن زوال عقل یا ناتوانی شدید
    Participate in Laughter Yoga sessions beforehand
    Severe memory loss
    Do not live in a nursing home
    Not a resident of Bojnoord city
    Participate in Laughter Yoga sessions beforehand
    Severe memory loss
    Do not live in a nursing home
    Not a resident of Shirvan city
    شرکت در جلسات یوگای خنده از قبل
    از دست دادن شدید حافظه
    مقیم خانه سالمندان نباشند
    ساکن شهر بجنورد نباشد
    شرکت در جلسات یوگای خنده از قبل
    از دست دادن شدید حافظه
    مقیم خانه سالمندان نباشند
    ساکن شهرشیروان نباشد
  • Recruitment centers

    #1
    Name of recruitment center - English: Azarmehr nursing home
    Name of recruitment center - Persian: خانه سالمندان آذرمهر
    Full name of responsible person - English: Azam Alidadian
    Full name of responsible person - Persian: اعظم علیدادیان
    Street address - English: Bojnoord, Esteghlal Blvd., Dariush St
    Street address - Persian: بجنورد، بلوار استقلال، خیابان داریوش
    City - English: Bojnurd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9461976199
    Phone: +98 58 4222 9276
    Fax:
    Email: nurse.saedikia@yahoo.com
    Web page address:
    Name of recruitment center - English: Anam nursing home
    Name of recruitment center - Persian: خانه سالمندان آنام
    Full name of responsible person - English: Saedieh Ansari
    Full name of responsible person - Persian: سعیده انصاری
    Street address - English: Shaghayegh 4, Felestin 31 Street, Shirvan County, North Khorasan
    Street address - Persian: خراسان شمالی، شهرستان شیروان، خیابان فلسطین 31، شقایق 4
    City - English: Shirvan
    City - Persian: شیروان
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9461976199
    Phone: +98 58 3636 0711
    Fax:
    Email: nurse.saedikia@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Mehrana nursing home
    Name of recruitment center - Persian: خانه سالمندان مهرانا
    Full name of responsible person - English: Azam Banihashem
    Full name of responsible person - Persian: اعظم بنی هاشم
    Street address - English: North Khorasan, Bojnurd, Shahada Boulevard, Khayyam
    Street address - Persian: خراسان شمالی، بجنورد، بلوار شهدا، خیام ۴
    City - English: Bojnurd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9461976199
    Phone: +98 58 3622 9535
    Fax:
    Email: nurse.saedikia@yahoo.com
    Web page address:
    Name of recruitment center - English: Hajar nursing home
    Name of recruitment center - Persian: خانه سالمندان هاجر
    Full name of responsible person - English: Saedieh Ansari
    Full name of responsible person - Persian: سعیده انصاری
    Street address - English: خراسان شمالی، شهرستان شیروان، خیابان شهید مصیب ایزانلو پشت آموزشگاه رانندگی حسینی
    Street address - Persian: North Khorasan, Shirvan County, Shahid Mosayeb Izanloo Street, behind Hosseini Driving School.
    City - English: Shirvan
    City - Persian: شیروان
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9461976199
    Phone: +98 58 3621 4413
    Fax:
    Email: nurse.saedikia@yahoo.com
    Web page address:
    #3
    Name of recruitment center - English: Pardis nursing home
    Name of recruitment center - Persian: خانه سالمندان پردیس
    Full name of responsible person - English: Maryam Vahani
    Full name of responsible person - Persian: مریم وحانی
    Street address - English: No. 20, No. 20, second alley on the left, after 32 meters from Shahrabazi, Bojnord, North Khorasan
    Street address - Persian: خراسان شمالی، بجنورد، انتهای هفده شهریور شمالی، بعد از ۳۲ متری شهربازی، کوچه دوم سمت چپ، پلاک ۲۰
    City - English: Bojnurd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9416716953
    Phone: +98 58 3622 9535
    Fax:
    Email: nurse.saedikia@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Bahram Bibak
    Full name of responsible person - Persian: بهرام بیباک
    Street address - English: Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnoord
    Street address - Persian: بجنورد ، بلوار دولت ، ساختمان مرکزی دانشگاه علوم پزشکی خراسان شمالی
    City - English: Bojnurd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3151 0000
    Fax:
    Email: INFO@NKUMS.AC.IR
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Bahram Bibak
    Full name of responsible person - Persian: بهرام بیباک
    Street address - English: Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnord Town.
    Street address - Persian: شهر بجنورد، بلوار دولت، ساختمان مرکزی دانشگاه علوم پزشکی خراسان شمالی.
    City - English: Bojnurd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3151 0000
    Fax:
    Email: INFO@NKUMS.AC.IR
    Web page address:

Protocol summary

Study aim
Determining the effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes in Shirvan 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 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.
Participants/Inclusion and exclusion criteria
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
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
Changing the study location from the Bojnurd nursing home to Shirvan.
Acronym
IRCT registration information
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
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
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2026-12-22, 1405/10/01
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 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
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
Anam nursing home
Full name of responsible person
Saedieh Ansari
Street address
Shaghayegh 4, Felestin 31 Street, Shirvan County, North Khorasan
City
Shirvan
Province
North Khorasan
Postal code
9461976199
Phone
+98 58 3636 0711
Email
nurse.saedikia@yahoo.com

2

Recruitment center
Name of recruitment center
Hajar nursing home
Full name of responsible person
Saedieh Ansari
Street address
خراسان شمالی، شهرستان شیروان، خیابان شهید مصیب ایزانلو پشت آموزشگاه رانندگی حسینی
City
Shirvan
Province
North Khorasan
Postal code
9461976199
Phone
+98 58 3621 4413
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.
Comments
Loading...