Aim: This study was performed to determine the Impact Training of Orem's self-care program on the quality of life in patients with migraine.
Design: This study is a randomized controlled clinical trial as before and after. Inclusion criteria: Diagnosis of migraine based on International headache indices by a physician, Age 55-18 years. Exclusion criteria: Lack of proper implementation of intervention and unwillingness to cooperate in any phase of the study.
Population and sample size: In this 83 patients with migraine were divided into two groups by random allocation: 43 of patients in experimental group and 40 patients in control group. Intervention: Self care Program were held as four 30-45 minutes training sessions based on their self care needs in Orem model for experimental group. The Check lists were used to monitor and follow-up self care programs Intervention time: the subjects were asked to apply self-care program for 3 months. Data collection tools were demographic questionnaire, Short Form SF36 and Orem cognition form and self care checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302023023N7
Registration date:2013-07-14, 1392/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Fatemeh MahmoudzadehZarandi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
fmahmudzadeh@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiatallah University of Medical Sciences
Expected recruitment start date
2009-11-11, 1388/08/20
Expected recruitment end date
2010-02-04, 1388/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact Orem's self-care nursing model on the quality of life in patients with migraine
Public title
Impact Orem's self-care nursing model on the quality of life in patients with migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of migraine based on International headache indices by a physician, Age 55-20 years Exclusion criteria: Pregnancy, menopause, History of cardiovascular diseases, hypertension.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
83
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiatallah University of Medical Sciences
Street address
Mollasadra street, Vanak Square
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
21
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
quality of life
Timepoint
baseline, three months later
Method of measurement
SF36 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: Implementation Orem's self-care nursing model in Nutrition, exercise and relaxation dimensions for three months
Category
Lifestyle
2
Description
The Control group: no action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Neurology Clinic of Baqiatallah Hospital
Full name of responsible person
Fatemeh MahmoudzadehZarandi
Street address
No. 160, Jafari street, Ferdowsi Avenue
City
Zarand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Farahrooz Hamedanizadeh
Street address
Baqiatallah University of Medical Sciences, Araj Three ways, Aqdasiyeh
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiatallah University of Medical Sciences
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
Birjand University of Medical Sciences
Full name of responsible person
Fatemeh MahmoudzadehZarandi
Position
Master of nursing education
Other areas of specialty/work
Street address
Ayatollah Ghaffari Street - Birjand University of Medical Sciences- paramedical faculty
City
Birjand
Postal code
Phone
+98 56 1444 0556
Fax
Email
fmahmudzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
Dr Abbas Ebadi
Position
PhD
Other areas of specialty/work
Street address
Baqiatallah University of Medical Sciences, Araj Three ways, Aqdasiyeh
City
Tehran
Postal code
Phone
+98 212952524
Fax
Email
ebadi1347@bmsu.ac.ir ebadi1347@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fatemeh MahmoudzadehZarandi
Position
Master of nursing education
Other areas of specialty/work
Street address
Ayatollah Ghaffari Street - Birjand University of Medical Sciences- paramedical faculty
City
Birjand
Postal code
Phone
+98 56 1444 0556
Fax
Email
fmahmudzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)