Protocol summary

Summary
This study was to determine the effect of implementation of Orem self care programs on headache indices in migraine headache. In this study, 83 patients with migraine headache (were randomly allocated in intervention or control groups. Data collection tools were included demographic data form, indices of migraine headaches, Orem cognition questionnaires, self care checklist, and form of headache diary. Self care program carried out in four theoretical and practical training sessions, each 30 to 45 minutes. Headache indices in migraine including frequency, intensity, and duration of headaches were evaluated through a headache questionnaire at the baseline and after two months of self care program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901303023N5
Registration date: 2010-06-03, 1389/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-03, 1389/03/13
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
Effectiveness of implementation of Orem Self -Care Programme on Headache Indices In Migraineur Referred To Selected Clinics of Tehran
Public title
Effectiveness of implementation of Orem Self-Care Programme on Headache Indices In Migraineur
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of migraine based on International headache indices by a physician, Ability of reading and writing, Age 55-18 years Exclusion criteria: unwilling to cooperate,Pregnancy, menopause, History of psychiatric disorders, History of other diseases such as asthma, diabetes, cardiovascular, or hypertension, health personnels
Age
From 18 years old to 55 years old
Gender
Both
Phase
4
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
Vanak Square, Mollasadra street
City
Tehran
Postal code
Approval date
1988-12-08, 1367/09/17
Ethics committee reference number
21

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Headache indices
Timepoint
2 mounth
Method of measurement
Qestionnaire

Secondary outcomes

empty

Intervention groups

1

Description
implementation of Orem self care programs
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical neurology clinic of Baqiatallah hospital
Full name of responsible person
Fatemeh Mahmudzadehzarandi
Street address
Vanak Square, Mollasadra street
City
Tehran

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
Baqiatallah university of Medical Sciences
Full name of responsible person
Fatemeh Mahmudzadehzarandi
Position
Master of nursing education
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
fmahmudzadeh@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiatallah university of Medical Sciences
Full name of responsible person
Fatemeh Mahmudzadehzarandi
Position
Master of nursing education
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
fmahmudzadeh@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiatallah university of Medical Sciences
Full name of responsible person
Fatemeh Mahmudzadehzarandi
Position
Master of nursing education
Other areas of specialty/work
Street address
Vanak Square, Mollasadra street
City
Tehran
Postal code
Phone
+98 21 7710 3723
Fax
Email
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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