This study will be conducted with the aim of comparative investigation of supportive counseling by individual and group methods on the level of menarche anxiety of female students.
Design
A randomized clinical trial with one control group and two intervention groups, double-blind, on 60 patients, will be conducted with SPSS software using descriptive and inferential data analysis tests.
Settings and conduct
This study will randomly select three elementary schools of the second period and three secondary schools of the first period from Mashhad's seven educational districts, then assign them to school-level groups according to the method. There will be replacement blocks to add second-year primary and first-year secondary schools to the intervention groups (individual and group support counseling) and control group. Participants and data assessors will be double-blind in this research.
Participants/Inclusion and exclusion criteria
The Inclusion criteria include the consent of parents and students to participate in the research, age 9 to 14 years, Iranian citizenship, occurrence of secondary sexual characteristics and absence of specific diseases, absence of stressful events in the past 6 months. The Exclusion criteria include not attending more than one counseling session and having any stressful incident while studying.
Intervention groups
Intervention Group One: There are groups that receive individual support counseling.
Second Intervention Group: There are groups that receive group support counseling.
Control Group: A group that does not receive study intervention
Main outcome variables
The primary outcomes are the overt and covert anxiety score, which will be examined in two stages before the start of counseling sessions and 4 weeks after the last counseling session in three groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240129060838N1
Registration date:2024-03-28, 1403/01/09
Registration timing:prospective
Last update:2024-03-28, 1403/01/09
Update count:0
Registration date
2024-03-28, 1403/01/09
Registrant information
Name
Mehri Soleymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4262 3523
Email address
soleimanim4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Individual and Group Supportive Counseling on Menarche Anxiety of Female Students.
Public title
Comparative Study of Individual and Group Supportive Counseling on Menarche Anxiety of Female Students.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian citizenship
Age 9-14 years
Having secondary sexual characteristics
At most 6 months have passed since the event of Menarche
Suffering from specific physical and mental diseases
The absence of stressful events such as death or incurable disease in first-degree family
Having mild and moderate anxiety according to the Spielberger questionnaire
Exclusion criteria:
Failure to attend more than one counseling session
Occurrence of any stressful incident while studying
Age
From 9 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, only one educational district will be chosen at random using a lottery system from the seven districts in Mashhad city. Subsequently, three elementary schools and three secondary schools from the chosen district will be picked randomly for the second term. Initially, they will be chosen by a random selection process known as a lottery. Group allocation will be conducted at the school level using the permutation block approach, using schools as clusters. In the study, a first-year secondary school student is assigned to the individual support counseling group, while a second-year primary school student and a first-year secondary school student are assigned to the group support counseling group. Additionally, a second-year primary school student and a first-year cooperative student are assigned to the control group.
0001: Category A A0002: Category C 0003: Category C 0004: Category A 0005: Category B 0006: Category B
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study, indicating that both the participant and the data analyst will be unaware of certain information. The participant is aware of their involvement in the research project but does not know whether they are in the control group or the intervention group. Prior informed consent was obtained from all participants to participate in the research. The data analyst, on the other hand, does not have access to the participants' names and can only identify them through a special code. This ensures that the analyst remains unbiased by the control or intervention groups and cannot make predictions about the study results based on personal opinions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
University St., Razavi Khorasan, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.135
Health conditions studied
1
Description of health condition studied
Unspecified behavioral syndromes associated with physiological disturbances and physical factors
ICD-10 code
F59
ICD-10 code description
Unspecified behavioral syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
Apparent anxiety score in the stage Before the start of counseling sessions and 4 weeks after the last counseling session in three groups
Timepoint
Before the start of counseling sessions and 4 weeks after the last counseling session
Method of measurement
Spilielberger State-Attribute Questionnaire
2
Description
Hidden anxiety score before the counseling session and 4 weeks after the last counseling session in three groups
Timepoint
Before the start of counseling sessions and 4 weeks after the last counseling session
Method of measurement
Spilielberger State-Attribute Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: consisted of students who met the research criteria and completed the Spielberger anxiety questionnaire. Specifically, students with mild and moderate anxiety, as indicated by scores below 52 for hidden anxiety and below 53 for manifest anxiety on the Spielberger Questionnaire, were identified and included in the research. Each student is provided with a set of research materials, which consist of a demographic questionnaire, Zung Anxiety Questionnaire, Rosenberg Self-Esteem Questionnaire, and Brooks-Gun and Rabel Menstrual Attitude Questionnaire. These items are given to all three groups. The length of indivitual supportive counseling in each group will be 60 minutes, as determined by the health education curriculum for patients. This curriculum covers topics such as communication and counseling skills, fundamental ideas in behavior modification, and the overall principles of counseling in behavior change. In addition to the empowerment strategies, the time of one hour is taken into consideration.There will be a weekly session for a total of three weeks in a row.
Category
Diagnosis
2
Description
Control group: The students who took part in the research were assessed for their eligibility based on specific criteria, and they also completed the Spielberger anxiety questionnaire. Only those students who scored below 52 for hidden anxiety and below 53 for manifest anxiety on the Spielberger Questionnaire were included in the study. Each student will be provided with a set of research instruments, including a demographic questionnaire, Zung Anxiety Questionnaire, Rosenberg Self-Esteem Questionnaire, and Brooks-Gun and Rabel Menstrual Attitude Questionnaire. These materials will be given to all three groups. Individuals in the control group do not receive any kind of intervention.
Category
Diagnosis
3
Description
The second Intervention group: consisted of students who met the research criteria and completed the Spielberger anxiety questionnaire. Specifically, students with mild and moderate anxiety, as indicated by scores below 52 for hidden anxiety and below 53 for manifest anxiety on the Spielberger Questionnaire, were identified and included in the research. Each student is provided with a set of research materials, which consist of a demographic questionnaire, Zung Anxiety Questionnaire, Rosenberg Self-Esteem Questionnaire, and Brooks-Gun and Rabel Menstrual Attitude Questionnaire. These items are given to all three groups. The length of group supportive counseling in each group will be 60 minutes, as determined by the health education curriculum for patients. This curriculum covers topics such as communication and counseling skills, fundamental ideas in behavior modification, and the overall principles of counseling in behavior change. In addition to the empowerment strategies, the time of one hour is taken into consideration.There will be a weekly session for a total of three weeks in a row.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Education Khorasan Razavi
Full name of responsible person
Seyed Amir Shushtri
Street address
Khorasan Razavi Department of Education,between Sarab Station and Shahada Square, Imam Khomeini St., Holy Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۳۷۱۴۱۶۵
Phone
+98 51 3221 3040
Email
razavi@medu.gov.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
management of university research affairs, central building of Mashhad University of Medical Sciences, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 3845 1521
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehri Soleymani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.56, Shahid Rangani St, Pastor Blv, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318914666
Phone
+98 51 4262 3523
Email
Soleimanim4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahbobe Firoozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Ferdowsi University of Mashhad, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
firoozim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehri soleymani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.56, Shahid Rangani St, Pastor Blv, Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
9318914666
Phone
+98 51 4262 3523
Email
Soleimanim4001@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available