Protocol summary

Summary
The two-group randomized control trial study, which aimed to evaluate the effectiveness of consulting on n body image coping strategy among secondary school girls. The study population will comprise secondary school girls. A sample of 60 students who met the inclusion criteria has been calculated. Inclusion criteria with block randomization placed in one of intervention and control groups. The intervention group perceive 4 weekly sessions of group counseling. Before and after the intervention and 14 days after the last sessions, the student ‘s body image and coping strategy to be measured by questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052927557N5
Registration date: 2017-06-27, 1396/04/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Mahnaz Akbari Kamrani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
dr.akbarikamrani@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of group consulting on body image coping strategy among secondary school girls
Public title
Assessment the effect of group consulting on body image coping strategy among secondary school girls
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being 15-18 years old; absence of acute and chronic diseases; absence of physical disability; not having acute family problems; living with both parents; having parental consent letter. Exclusion criteria: not being interested to continue the study.
Age
From 15 years old to 18 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
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
Alborz University of Medical Sciences
Street address
Department of Midwifery., Alborz University of Medical Science., Eshteraki St., Baghestan Blv
City
Karaj
Postal code
561-31452
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
Abzums.Rec.1395.148

Health conditions studied

1

Description of health condition studied
body image coping strategy
ICD-10 code
F98
ICD-10 code description
Other behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Primary outcomes

1

Description
Body image
Timepoint
Before and after intervention, 2 weeks after the end of intervention
Method of measurement
MBSRQ questionnaire

Secondary outcomes

1

Description
Coping strategy
Timepoint
Before and after intervention, 2 weeks after the end of intervention
Method of measurement
BICSI questionnaire

Intervention groups

1

Description
Counseling group receive 4 sessions counseling intervention.
Category
Behavior

2

Description
Control group won't receive any intervention during study. They will receive an evidence based booklet after the study.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj Department of Education
Full name of responsible person
Najla Irani
Street address
Beside Meli Bank., Kharkhane Ghand St
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
Research& Technology Office., Alborz University of Medical Science., Yasamin St., Poneh St., - Golshahr BLv
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Najla Irani
Position
Student
Other areas of specialty/work
Street address
Department of Midwifery., Alborz University of Medical Science., Eshteraki St., Baghestan Blv
City
Karaj
Postal code
Phone
+98 26 3433 6007
Fax
Email
irannajla@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Assistant Professor/ PhD
Other areas of specialty/work
Street address
Department of Midwifery., Alborz University of Medical Science., Eshteraki St., Baghestan Blv
City
Karaj
Postal code
Phone
+98 26 3433 6009
Fax
Email
Dr.akbarikamrani@abzums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Assistant Professor/ PhD
Other areas of specialty/work
Street address
Department of Midwifery., Alborz University of Medical Science., Eshteraki St., Baghestan Blv
City
Karaj
Postal code
Phone
+98 26 3433 6009
Fax
Email
Dr.akbarikamrani@abzums.ac.ir
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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