Protocol summary

Study aim
Pain is a critical threat for elderly people and it is the main cause of their disability. Chronic musculoskeletal pain is a common problem among elderly people, which results in health problems and mobility reduction. Apart from costly and complicated drug treatments, there is also many complementary therapies such as exercising. The aim of this study is to investigate the effect of yoga on chronic musculoskeletal pain in elderly women.
Design
The present study is a clinical trial study. The statistical population includes 60 years old elderly women referring to selected comprehensive health centers. Samples are divided into control and intervention groups randomly.
Settings and conduct
The intervention group does yoga under supervision of the coach, 3 sessions every week and an hour per session for 8 weeks. Before intervention and after 4 and 8 weeks, the pain questionnaire will be filled by the intervention and control group. The data were analyzed by SPSS 18 software and using descriptive and analytical statistical tests.
Participants/Inclusion and exclusion criteria
The present study will be conducted on 60-75 years old elderly women who referred to selected comprehensive health centers and had musculoskeletal pain for at least 3 months, had not history of mental illness, Parkinson's disease, Alzheimer's disease, recent fracture, drug addiction, And not doing other sports At the same time with study and having no limitation for exercising.
Intervention groups
The intervention group does yoga under supervision of the coach, 3 sessions every week and an hour per session for 8 weeks.
Main outcome variables
musculoskeletal pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150519022320N11
Registration date: 2018-07-07, 1397/04/16
Registration timing: retrospective

Last update: 2018-07-07, 1397/04/16
Update count: 0
Registration date
2018-07-07, 1397/04/16
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
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of Yoga on musculoskeletal pain in elderly females.
Public title
Investigation the effect of Yoga on musculoskeletal pain in elderly females.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
female gender Age of 60 to 75 years old Informed consent to participate in the project Existence of complaint about musculoskeletal pain for three months pain Severity range of ten to forty
Exclusion criteria:
Absence of mental illnesses history Absence of Parkinson's disease Absence of Alzheimer's disease history Not doing other sports during research Absence of any recent fractures No addiction to drugs Having no limitation for exercising
Age
From 60 years old to 75 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
In this study, people are divided into two control and Intervention groups of 30 persons by simple random method
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 Rafsanjan University of Medical Sciences
Street address
Emam Ali Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
Rums.rec.1396.216

Health conditions studied

1

Description of health condition studied
Musculoskeletal pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
musculoskeletal pain score
Timepoint
The severity of pain in the control and intervention group will be measured before the beginning of the intervention and 4 and 8 weeks after the intervention, by the McGill questionnaire.
Method of measurement
McGill Pain Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group does yoga under supervision of the coach, 3 sessions every week and 60 minutes per session for 2 months
Category
Lifestyle

2

Description
Control group: Any intervention is done on control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
selected comprehensive health centers
Full name of responsible person
Dr Tayyebe Mirzaei
Street address
Jomhory street, Parastar blv
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.Alishamce zadeh
Street address
Faculty of Nursing, Nurse blv, Jomhury street
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.mirzaie@rums.ac.ir
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.Tayyebeh Mirzaei
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blv, Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
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
Tayyebeh Mirzaei
Position
ScienceCommittee
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blv, Jomhury street
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3422 0038
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
Tayyebeh Mirzaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty Of Nursing, Nurse blv, Jomhury street
City
Rafsanjan
Province
Kerman
Postal code
77181747715
Phone
+98 34 3434 0608
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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