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The effect of laughter yoga on General health and happiness of postmenopausal women

Protocol summary

Study aim
Determining the effect of laughter yoga on the general health and happiness of postmenopausal women
Design
A Quasi-experimental clinical trial, with a control group, without blinding, with allocation of two centers for the two groups, on 62 postmenopausal women.
Settings and conduct
The intervention group will participate in eight 45-minute sessions twice a week of laughter yoga exercises held in the Faculty of Nursing, Midwifery and Management of Iran University of Medical Sciences, Tehran, by the researcher and under the supervision of an international laughter yoga coach. The control group in the central campus of Iran University of Medical Sciences will only receive the illustrated pamphlet of Laughter Yoga prepared by the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: menopausal women 65 years old and younger. Exclusion criteria: having acute physical diseases, 3rd and 4th degree hernia, hemorrhoids, heart disease, epilepsy, severe back pain, 4th degree uterine prolapse, use of hormone replacement therapy, history of mental illness or history of stressful events in three in the last month, the experience of participating in laughter yoga, music therapy, meditation and relaxation classes, taking neuropsychiatric and sedative drugs.
Intervention groups
Intervention group: participation in 8 sessions of 45 minutes, twice a week Control group: receiving the illustrated booklet of Laughter Yoga prepared by the researcher
Main outcome variables
General health, happiness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230225057525N1
Registration date: 2023-04-17, 1402/01/28
Registration timing: prospective

Last update: 2023-04-17, 1402/01/28
Update count: 0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Homa Sadeghi Avvalshahr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
sadeghiavalshahr.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of laughter yoga on General health and happiness of postmenopausal women
Public title
The effect of laughter yoga on health and happiness
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women 65 years old and younger
Exclusion criteria:
Having diseases such as: hernia, hemorrhoids (grade 3 and 4 based on the question of the symptoms of the disease) Suffering from heart problems or chest pain, epilepsy, severe back pain, uterine prolapse (procidentia based on the person's statements and asking about the symptoms of the disease) Use of hormone replacement therapy Having a history of mental illness based on the person's statements Having experience participating in laughter yoga classes Taking neuropsychological and sedative drugs based on the person's statements Having experience participating in music therapy, dance, meditation or relaxation classes
Age
To 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.IUMS.REC.1401.640

Health conditions studied

1

Description of health condition studied
General health, happiness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
General health:: According to the definition of the World Health Organization(1998), health is a state of complete physical, mental and social health, not just the absence of disease or infirmity .
Timepoint
Before the start of the intervention, after the end of the intervention and one month later
Method of measurement
General health will be measured using 28-Item General Health Questionnaire.

2

Description
Happiness: According to Diener's definition ( 2002), happiness is the evaluation that a person makes of himself and his life. This evaluation can have a cognitive aspect, such as judgments about life satisfaction, or an emotional aspect that includes the mood and emotions that appear in response to life events. Therefore, happiness consists of the following components, which are: satisfaction with life, positive and pleasant moods and emotions, the absence of negative emotions and feelings, and other factors such as optimism, self-esteem, and a sense of prosperity are involved in it.
Timepoint
Before the start of the intervention, after the end of the intervention and one month later
Method of measurement
Happiness will be measured using the Oxford Happiness Questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Participating in the practice sessions of the laughter yoga program, which includes eight 45-minute sessions twice a week.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Dr. Hamid Peyravi
Street address
Faculty of Nursing and Midwifery, Iran University of Medical Sciences, , Rashid Yasmi St., Valiasr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
fnm@iums.ac.ir

2

Recruitment center
Name of recruitment center
Faculty of Medical Information and Management, Iran University of Medical Sciences
Full name of responsible person
Dr. Soudabe Vatankhah
Street address
Faculty of Medical Information and Management, Iran University of Medical SciencesRashid, Yasemi St. Valiasr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8879 4301
Fax
+98 21 8888 3334
Email
public.shmis@iums.ac.ir

3

Recruitment center
Name of recruitment center
Faculty of Medicine, Iran University of Medical Sciences
Full name of responsible person
‪Dr. Fahimeh soheilipour‬
Street address
Faculty of Medicine, Iran University of Medical Sciences , next to Milad Tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
Schoolofmedicine@iums.ac.ir

4

Recruitment center
Name of recruitment center
faculty of allied medical sciences, Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Neshastehriz
Street address
faculty of allied medical sciences, Iran University of Medical Sciences, next to Milad Tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir

5

Recruitment center
Name of recruitment center
School of Public Health, Iran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Vafa
Street address
School of Public Health, Iran University of Medical Sciences, next to Milad Tower, Hemmat highway,
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir

6

Recruitment center
Name of recruitment center
School of Advanced Technology in Medicine, Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Taghi Joghataei
Street address
School of Advanced Technology in Medicine, Iran University of Medical Sciences, next to Milad Tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Abdolreza Pazouki
Street address
Iran University of Medical Sciences, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Homa Sadeghi Avval Shahr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing & Midwifery, Rashid Yasemi St. Valiasr St
City
تهران
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
009843651810
Fax
Email
sadeghiavalshahr.h@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Homa Sadeghi Avval Shahr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1810
Email
sadeghiavalshahr.h@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Homa Sadeghi Avval Shahr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1810
Email
sadeghiavalshahr.h@iums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Submit an official application form from the workplace
From where data/document is obtainable
E-mail address of the researcher: sadeghiavalshahr.h@iums.ac.ir
What processes are involved for a request to access data/document
Sending the official request approved by the directorate of the educational or research institution via academic email to the researcher's email, verifying the applicant's information, sending the requested information after anonymizing the information.
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