The effectiveness of laughter yoga on depression and anxiety in women 50 To 70 years old
Design
A single-blind randomized controlled clinical trial will be conducted on 60 women aged 50-70 years old, member of the Association of Education Retirees in two intervention and control groups. The subjects will be randomly allocated in the intervention and control groups, using random numbers.
Settings and conduct
Intervention will be done in the gym by doing yoga exercises. Control group will receive no intervention. Depression and anxiety will be evaluated by co-researcher who is blind to grouping, using the Beck Depression and Anxiety Inventory.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Being the member of the Association of Retirees for Education; Age between 50 and 70 years; Depression scores above 10 based on the Beck's Depression Inventory; Anxiety score above 8 based on Beck's Anxiety Inventory; Ability to do the exercises based on Laughter yoga instructor confirmation; Being independent in activities of daily living; Ability to communicate; Non-Inclusion Criteria: Suffering from major depressive disorder or generalized anxiety disorder base on psychiatrist diagnosis; Using other complementary therapies.
Intervention groups
In the intervention group, women aged 50-70 years will do laughter yoga exercises in the gym for eight weeks, two sessions in a week, 90 minutes per session, under the supervision of certificated laughter yoga instructor. Control Group receives no intervention.
Main outcome variables
Depression and anxiety scores by Beck Beck Questionnaire, at the beginning of the study And the fourth and eighth weeks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039804N1
Registration date:2018-08-06, 1397/05/15
Registration timing:registered_while_recruiting
Last update:2018-08-06, 1397/05/15
Update count:0
Registration date
2018-08-06, 1397/05/15
Registrant information
Name
hassan mokarrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3231 3623
Email address
h.mokarrami@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of laughter yoga on anxiety and depression in women aged 50 to 70
Public title
Anxiety and depression in women aged 50 to 70
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 to 70
Being independent in activities of daily living
Ability to communicate (awareness of time, place, and people)
Exclusion criteria:
Use of other supportive and complementary therapies
Having Major Depression and Generalized Anxiety Disorder
Having problems and physical illnesses
having scores of less than 10 and 8 respectively for Beck's Depression Inventory and Beck's Anxiety Inventory
suffering from acute illnesses
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly allocating of the elderly to the intervention and control groups, using random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, it is not possible to blind subjects due to the nature of the intervention; and instead, to reduce bias, the co-researcher as assessor will be blind. But, there is no choice for the situation in which only the "assessor" is blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of north khorasan University of Medical Sciences
Street address
Central building of north khorasan University of Medical Sciences, Dolat Blvd., Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.nkums.REC.1397.011
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Depression
Timepoint
Study onset, week 4, and week 8
Method of measurement
Beck's depression inventory
2
Description
Anxiety
Timepoint
Study onset, week 4, and week 8
Method of measurement
Beck's Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after training, participants will be asked to implement laughter yoga protocol for 8 weeks, 2 sessions in a week, and 90 minutes each session; and the level of their depression and anxiety will be measured using Beck Depression Inventory, and Beck Anxiety Inventory at the study onset, and end of the fourth and eighth weeks. Control group, will receive no intervention.
Category
Other
2
Description
Control group: Receives no intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bojnurd Education Retirees Association
Full name of responsible person
Behzad Mohammad zadeh
Street address
Building of education retirees association, Basij crossroad, Bojnurd.
City
Bojnurd
Province
North Khorasan
Postal code
9415936993
Phone
+98 58 3222 2600
Fax
+98 58 3222 2600
Email
behzadmohmmadzade14@gmail.com
Web page address
http://nurse.nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Kaveh Hojjat
Street address
Central building of north khorasan university of Medical Sciences, Dolat Blvd.
City
Bojnurd
Province
North Khorasan
Postal code
9419474877
Phone
+98 58 3222 1910
Fax
+98 58 3222 2122
Email
info@nkums.ac.ir
Web page address
http://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
Hassan mokarrami
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bojnurd school of nursing and midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Fax
+98 58 3222 2122
Email
h.mokarrami@nkums.ac.ir
Web page address
http://nurse.nkums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Reza Armat
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bojnurd school of nursing and midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Fax
+98 58 3229 7095
Email
armat@nkums.ac.ir
Web page address
http://nkums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hassan Mokarrami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bojnurd school of nursing and midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Fax
+98 58 3229 7095
Email
h.mokarrami@nkums.ac.ir
Web page address
http://nurse.nkums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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