This study will be done with aim to investigate the effectiveness of group discussion on menarche anxiety in girls primary school students. This is not blinded clinical trial.The study population will be included all eligible students of Gilangharb city that a total of 60 of them will be selected by cluster sampling and randomly will be assigned in to two experimental and control groups. At baseline Spielberger questionnaire will be provided for both groups. Intervention group to create knowledge and increasing awareness will receive 6 sessions of group discussion in the field of genital tract activity and Menstrual cycle and the changes associated with puberty once a week and the control group will not receive any training. 4 weeks after the last group discussion the questionnaire will be completed by both control and intervention groups and both groups will be compared in terms of level of anxiety.
Inclusion criteria: Age between 10 and 12 years; Have not experienced first menses;Having secondary sexual characteristics; No special physical and psychiatric disease
Exclusion criteria: The occurrence of menarche in girls before the completion of group discussion; No participate in two or more sessions of group discussion
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050114333N74
Registration date:2017-07-04, 1396/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-04, 1396/04/13
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effectiveness and non-effectiveness of group discussion on menarche anxiety in girls primary school students
Public title
The effect of group discussion on the menarche's anxiety among girls elementary students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 10 and 12 years; Have not experienced first menses;Having secondary sexual characteristics; No special physical and psychiatric disease
Exclusion criteria: The occurrence of menarche in girls before the completion of group discussion; No participate in two or more sessions of group discussion
Age
From 10 years old to 12 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
kums.rec.1396.79
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Menarche anxiety
Timepoint
Baseline, four weeks after the end of the study
Method of measurement
Using the Spielberger questionnaire (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
The control group will not receive any training
Category
Other
2
Description
Intervention group to create knowledge and increasing awareness will receive 6 sessions of group discussion in the field of genital tract activity and Menstrual cycle and the changes associated with puberty once a week
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gilan Gharb city schools
Full name of responsible person
Zhra Pourfarjam
Street address
Gilan Gharb
City
Gilan Gharb
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Pourfarjam
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
s.pourfarjam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mozhgan kalily
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
khalily 1267@yahoo. Com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Pourfarjam
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
s.pourfarjam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)