Protocol summary

Study aim
Effect of Pilates Exercise on the Anxiety and Self-Esteem of Emergency Medical Students
Design
Clinical trials,with parallel groups, block randomization Sample size: 62 people
Settings and conduct
This isan experimental research.Sixty-six people were selected by available method from students of medical emergencies of Neyshabur Medical School who had entry criteria.The samples were randomly divided into two groups of test and control.A questionnaire survey tool Individual information was Cooper Smith's self-esteem questionnaire and Spilberger's apparent and hidden anxiety.The test group performed eight Pilatesweekly exercises twice a week and every 60 minutes with the instructor.The control group during this period Self-esteem and anxiety by using a questionnaire,at the beginning of the intervention and eight weeks later.The intervention is completed in a self-reporting manner.
Participants/Inclusion and exclusion criteria
Entry requirements: the age is between 19-30 years old, Student studying medical emergencies, Exit terms: having a previous history of physical and mental illness, tension problems in the last 6 weeks, Exercise regularly in the last month, use of drugs and sedative medicines
Intervention groups
Pilates exercises in Pilates exercises in two 60-minute sessions for a period of eight weeks. Pilates preparation techniques include pilates standing, Pilates breathing, and the flooring of both hands to the ground.The control group during this period was assigned to Continue their daily routine.The level of self-esteem and anxiety by using aquestionnaire is completed at the beginning and eight weeks after the intervention. In the control group, thepre-intervention questionnaire and after the daily activities at the end of the study, are completed with the time of the intervention group.
Main outcome variables
effect on self esteem and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181118041692N1
Registration date: 2019-02-11, 1397/11/22
Registration timing: retrospective

Last update: 2019-02-11, 1397/11/22
Update count: 0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
Zohreh Sarchahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 3294
Email address
zohrehsarchahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pilates exercise on anxiety and self-esteem in medical emergencies students
Public title
The effect of Pilates exercise on anxiety and self-esteem
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
the age is between 19-30 years old Student studying medical emergencies
Exclusion criteria:
having previous history of physical and mental illness tension problems in the last 6 weeks Exercise regularly in the last month use of drugs and sedative medicines
Age
From 19 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Actual sample size reached: 62
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign individuals to the two groups and guarantee the balance of the number of individuals in the groups, a random block method will be used. In this study, four-dimensional blocks will be created in which randomly half of the individuals in each block will be in one group and half in the other group. To do this, first all of the possible modes that half of the subjects are assigned to group A (test group) and the other half to the group B (control group) are determined: 1-AABB 2-BBAA 3-ABAB 4-BABA 5-ABBA 6-BAAB Then each of the four combinations will be one of the digits 1 to 6, and from numbers 1 through 6 randomly, repeated choices are made with the placement. Selected blocks are tagged in a sequential sequence, and according to the sequence, the individuals entered into the study will be assigned to one of the two groups A or B. Random selection of blocks will continue to reach the sample size of the study.
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
Neyshabour University of Medical Sciences
Street address
Neyshabour University of Medical Sciences, Janbazan Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319913589
Approval date
2017-11-16, 1396/08/25
Ethics committee reference number
IR.NUMS.REC.1396.35

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

2

Description of health condition studied
Self-esteem
ICD-10 code
F88
ICD-10 code description
Other disorders of psychological development

Primary outcomes

1

Description
Anxiety
Timepoint
Beginning of the intervention and eight weeks after the intervention
Method of measurement
Spilberger's apparent and hidden anxiety questionnaire

2

Description
Self-esteem
Timepoint
Beginning of the intervention and eight weeks after the intervention
Method of measurement
Cooper Smith questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Pilates exercises are conducted in the course of 8 weeks twice a week for 60 minutes with the coach. The amount of anxiety and self-esteem in the beginning of the intervention and eight weeks after the intervention was assessed using the Spielberger Anxiety Inventory and the Cooper Smith Questionnaire.
Category
Prevention

2

Description
Control group: Continue their daily activities. The amount of anxiety and self-esteem was completed by using the Spielberger Anxiety Questionnaire and the Cooper Smith Questionnaire before and after the intervention at the end of the study, in coincidence with the intervention group time.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neyshabour University of Medical Sciences
Full name of responsible person
Zohreh Sarchahi
Street address
Neyshabour University of Medical Sciences, Janbazan Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319913589
Phone
+98 51 4261 3294
Email
zohrehsarchahi@gmail.com
Web page address
https://www.nums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Street address
Neyshabour University of Medical Sciences, Janbazan Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319913589
Phone
+98 51 4261 3294
Email
zohrehsarchahi@gmail.com
Web page address
https://www.nums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
zZohreh Ssarchahi
Position
Faculty member of nursing & midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan Blvd, Neyshabour University of Medical Sciences
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319913589
Phone
+98 51 4261 3294
Email
zohrehsarchahi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Zohreh Sarchahi
Position
Faculty member of nursing & midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan Blvd, Neyshabour University of Medical Sciences
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319913589
Phone
+98 51 4261 3294
Email
zohrehsarchahi@gmail.com
Web page address
https://www.nums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Zohreh Sarchahi
Position
Faculty member of nursing & midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan Blvd, Neyshabour University of Medical Sciences
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319913589
Phone
+98 51 4261 3294
Email
zohrehsarchahi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
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