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The effect of progressive muscle relaxation program on sleep quality in pre-university students

Protocol summary

Summary
The aim of this study was to determine the effects of progressive muscle relaxation on sleep quality pre-university students. In this clinical trial, 46 pre-university students from public schools Malayer city that inclusion criteria are randomized into two groups of progressive muscle relaxation (test) and take control. In the case group of progressive muscle relaxation training program will be asked to do this once a day for a month. The instruments are "Pittsburgh Sleep Quality Index", sheet relaxation and demographic questionnaire. The sleep quality of the samples using "Pittsburgh Sleep Quality Index", will be measured at the beginning and end of the intervention. Inclusion criteria include: Students who do not have any history of sleep disorders. Mourning history and history of hospitalization in the last 6 months have not, do not have any history of drug use and the completion of "Pittsburgh Sleep Quality Index", 5 and have more business and exclusion criteria were: non-completion questionnaire , failure to attend educational sessions, participate in any class consultation with psychiatrists, occurring situations disaster near death, parental divorce, accident, illness and possible hospitalization during treatment, do relaxation program forward less than 15 times intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080123450N1
Registration date: 2015-09-06, 1394/06/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-06, 1394/06/15
Registrant information
Name
Tahereh Roozbahani
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
t.roozbahani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery Research Committee
Expected recruitment start date
2014-10-22, 1393/07/30
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation program on sleep quality in pre-university students
Public title
effect of relaxation on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of the study include: students do not have history of disease such as cancer, diabetes cardiovascular problems, hepatitis, epilepsy, muscular paralysis, anemia, ulcers, asthma, kidney problems, migraine headaches and sleep disorders; do not have a history of mourning in the last 6 months; do not have history of hospitalization in the last 6 months; do not have a history of taking certain medications; have the necessary cooperation for the study; the completion of "quality index Pittsburgh Sleep ", 5 and have won more. Exclusion criteria included: failure to complete the questionnaire; absence of training sessions; not wanting to continue the cooperation in the study; participate in any class consultation with psychiatrists who study its possible impact on psychological variables; the occurrence of adverse situations such as the death of someone close; Her parents' divorce and an accident that reduces a person's motivation to continue the study; the risk of illness and hospitalization during treatment; perform progressive relaxation program more than 15 times during a month-long intervention
Age
From 16 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Postal code
Approval date
2015-05-01, 1394/02/11
Ethics committee reference number
SBMU2.REC.1394.15

Health conditions studied

1

Description of health condition studied
sleep disorder
ICD-10 code
f51
ICD-10 code description
Nonorganic sleep disorders

Primary outcomes

1

Description
sleep quality
Timepoint
befor and 30 days after relaxation
Method of measurement
Pittsburgh sleep quality index

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group, progressive muscle relaxation program that during the 5 sessions of educational CD, booklet and PowerPoint students will be trained and they will be asked to once a day for a month bedtime this program do
Category
Behavior

2

Description
In the control group not trained and there is no action
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyfiyeh High school
Full name of responsible person
Tahereh Roozbahani
Street address
Alley Emamy, Park Aveniue
City
Malayer

2

Recruitment center
Name of recruitment center
Fatemieh High school
Full name of responsible person
Tahereh ROOZBAHANI
Street address
Rajai Alley, Sadi Aveniue
City
Malayer

3

Recruitment center
Name of recruitment center
Motahary High school
Full name of responsible person
Tahereh Roozbahani
Street address
Shahid Sadogi Alley, Barg Ball Aveniue
City
Malayer

4

Recruitment center
Name of recruitment center
Eshgi Fard High school
Full name of responsible person
Tahereh Roozbahani
Street address
Alley Shadi, Hamedan Avenue
City
Malayer

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Nursing and Midwifery shahid Beheshti
Full name of responsible person
Amirhosayn Barbaz Esfahani
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery shahid Beheshti
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kiarash Saatchi
Position
Physical Therapist
Other areas of specialty/work
Street address
Shahab Building, Hasht Behesht Aveniue, Golha Street
City
Tehran
Postal code
Phone
+218 8993099
Fax
Email
dr.saatchi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery
Full name of responsible person
Manigeh Norian
Position
PhD Student in Nursing Education
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery, Niyayesh Intersection, Valiasr Aveniue
City
Tehran
Postal code
Phone
+218 8655966
Fax
Email
manigeha@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Roozbahani
Position
MS nursing
Other areas of specialty/work
Street address
Plaque7680, Etehad alley, Shohada Avenue
City
Malayer
Postal code
6571831579
Phone
+98 81 3334 5045
Fax
Email
t.roozbahani@sbmu.ac.irt.roozbahani@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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