The purpose of this study was to compare the effect of music therapy with laughter yoga on depression in the elderly referred to health centers in Rafsanjan in 2022.
Design
90 eligible seniors will be divided into 3 groups (two intervention groups and one control group) using a simple random division method using a random number table, and the type of intervention will be determined again by random division on each group.
Settings and conduct
For depressed elderly people referred to Rafsanjan health centers, music intervention is done using headphones at home and laughter yoga intervention is done in groups in the gym.
Participants/Inclusion and exclusion criteria
Earn a score higher than 6 from the GDS questionnaire
No addiction and use of psychiatric drugs
No severe physical or mental problems
No cognitive impairment
No psychological problems in the last 6 months ؛
Reluctance to continue cooperation
Start taking antidepressants
Perform other exercises and interventions that affect depression
Do not do more than 3 sessions of exercises
Intervention groups
The music intervention group will undergo music therapy for 8 weeks and 2 sessions per week for 30 minutes.
The Laughter Yoga intervention group will undergo Laughter Yoga intervention for 8 weeks and 2 sessions per week.
The control group will be voiced over 8 weeks in the WhatsApp group about the problems that will occur in the aging process and their medical questions and problems will be answered.
Main outcome variables
depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N25
Registration date:2022-02-22, 1400/12/03
Registration timing:registered_while_recruiting
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of music therapy and laughter yoga on depression in the elderly
Public title
Comparison of the effect of music therapy and laughter yoga on depression in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 60 years old
Lack of severe hearing problems
Ability to use a smartphone
Obtaining a score higher than 6 from the GDS questionnaire
No addiction and use of psychiatric drugs
Not having severe physical and mental problems
Do not suffer from cognitive disorders based on medical diagnosis and being treated
No psychological problems in the last 6 months
Exclusion criteria:
Reluctance to continue cooperation
Start taking antidepressants
Performing exercises and other interventions that affect depression
Do not do more than 3 sessions of exercises
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After identifying the depressed elderly according to the inclusion criteria and its listing, they will be divided into 3 groups of 30 people A, B and C by simple random division using a table of random numbers and then the groups will be divided again by simple random division. On each group (2 intervention groups and one control group) it will be determined what intervention will be done on each 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
Research Ethics Committee of Rafsanjan University of Medical Sciences
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.RUMS.REC.1400.235
Health conditions studied
1
Description of health condition studied
Depression in the elderly
ICD-10 code
ICD-10 code description
Depression
Primary outcomes
1
Description
GDS Questionnaire Depression Score
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Geriatric Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The music intervention group will undergo music therapy for 8 weeks and 2 sessions per week for 30 minutes. The type of music to be intervened is a piece prepared with soothing songs with a gentle, happy and relaxing style, and preferably first the priority will be chosen by the taste of the elderly, and finally the final music file will be approved by the tutor and the consultant. This intervention will be done at home and preferably with headphones on pre-determined and agreed days by the researcher and the elderly for 30 minutes to the songs that are uploaded to the WhatsApp group and how to follow it. They were asked to notify the researcher immediately after listening to the music on the pre-arranged day.
Category
Treatment - Other
2
Description
Intervention group: The Laughter Yoga intervention group will also undergo Laughter Yoga intervention for 8 weeks and 2 sessions per week. The laughter yoga intervention group is divided into two groups, men and women, and as a group, the intervention in the gym will be pre-determined and will be performed on the elderly group at a time determined and predetermined by the researcher. During these 8 weeks of intervention, if the corona peak starts again and interrupts the intervention, this intervention will be followed virtually and a training video on how to perform Laughter Yoga in WhatsApp will be sent to them and in WhatsApp the absence of direction. Ensure the implementation of the intervention will be done.
Category
Treatment - Other
3
Description
Control group: The control group will be formed by the WhatsApp group for 8 weeks by the researcher, and the problems that will arise in the aging process will be explained aloud, and their medical questions and problems will be answered.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers in Rafsanjan
Full name of responsible person
Dr.Tayebeh Mirzaei
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Reza Vazirinejad
Street address
Emam َ Ali blvd
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Fax
+98 34 3425 8497
Email
T.Mirzaei@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34255900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.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