Protocol summary

Study aim
Studying the effectiveness of mindfulness-based stress reduction training on test anxiety, distress tolerance, and perceived stress in sixth grade male students with clinical symptoms of test anxiety
Design
A controlled clinical trial, without blinding, was conducted on 40 patients using cluster randomization.
Settings and conduct
To select the sample to determine the validity and reliability of the tools, a cluster random sampling method will be used. First, from the four education districts of the city of Essaouira, Iraq, two districts will be selected by simple random drawing (lottery), and then from each district, four sixth-grade boys' schools will be selected, and in the next stage, two sixth-grade boys will be selected from each school. Then, they will complete the test anxiety, distress tolerance, and perceived stress questionnaires.
Participants/Inclusion and exclusion criteria
Entry criteria for the study: 1- No serious physical illness 2- No participation in other educational sessions at least one month before the study 3- Obtaining a score of one standard deviation above the mean in test anxiety 4- No substance use Exit criteria for the study: 1- Absence of more than two sessions 2- Participation in other educational sessions 3- Unwillingness to continue treatment
Intervention groups
To select the sample for testing the hypotheses, students who had a test anxiety score of one standard deviation above the mean in the Spielberger Test Anxiety Inventory and who also showed symptoms of test anxiety in the clinical interview were selected to participate in the study by simple random sampling. Then, these individuals were randomly divided into two groups of 20: experimental and control. It should be noted that the control group will not receive any intervention during the study.
Main outcome variables
Mindfulness-based stress, test anxiety, distress tolerance, perceived stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250811066811N1
Registration date: 2025-08-14, 1404/05/23
Registration timing: registered_while_recruiting

Last update: 2025-08-14, 1404/05/23
Update count: 0
Registration date
2025-08-14, 1404/05/23
Registrant information
Name
Safaa Tarek Zghair Aigaiawy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3333
Email address
zarg3553@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-14, 1404/05/23
Expected recruitment end date
2025-09-11, 1404/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of mindfulness-based stress reduction training on test anxiety, distress tolerance, and perceived stress in sixth grade male students with clinical symptoms of test anxiety
Public title
Studying the effectiveness of mindfulness-based stress reduction training on test anxiety, distress tolerance, and perceived stress in sixth grade male students with clinical symptoms of test anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
No serious physical illness No participation in other educational sessions for at least one month prior to the study Achieving a score one standard deviation above the mean in test anxiety No substance use
Exclusion criteria:
Absence of more than two sessions Participation in other educational sessions Unwillingness to continue treatment
Age
From 11 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
To select a sample to diagnose test anxiety in students, a cluster random sampling method is used. First, two districts are randomly selected from four education districts, and then five sixth-grade boys' schools from each district and, in the next stage, two sixth-grade boys' schools from each school will be selected. Then, after the students completed the Spielberger Test Anxiety Inventory, those whose scores on this questionnaire were one standard deviation above the mean and who were given a final diagnosis of test anxiety in a clinical interview conducted by a clinical psychologist were selected as students with test anxiety.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz Branch
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
Approval date
2025-07-23, 1404/05/01
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.214

Health conditions studied

1

Description of health condition studied
Clinical symptoms of test anxiety
ICD-10 code
F98.8
ICD-10 code description
Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence

Primary outcomes

1

Description
Mindfulness-Based Stress Reduction: In this method, with a psychological understanding, the mind-body medicine models of stress are integrated with findings related to how to cope with the challenges of modern life. Therefore, this program includes intensive mindfulness meditation training and participants are trained to apply what they have learned practically in relation to the problems of managing the challenges of daily life. To select the sample for testing the hypotheses, students who in the previous stage, their test anxiety level on the Spielberger Test Anxiety Inventory was one standard deviation above the mean and who also showed symptoms of test anxiety in the clinical interview were selected to participate in the study by simple random selection. Then, these individuals will be randomly divided into 2 groups of 20 (20 in the experimental group and 20 in the control group). It should be noted that the control group will not receive any intervention during the study. However, to avoid factors threatening the internal validity of the study, such as compensatory competition from the control group or demoralization, they will be assured that they will receive mindfulness-based stress reduction training in the next session (after data collection).
Timepoint
Mindfulness-based stress reduction training sessions were developed based on the Kabat-Zinn method (2013) and are implemented in 8 90-minute sessions, two sessions per week, for 1 month.
Method of measurement
The measurement tools will include: Ahwaz Abolghasemi et al.'s Test Anxiety Inventory (1996), Spielberger's Test Anxiety Inventory (1980), Simmons and Gahr's Distress Tolerance Questionnaire (2005), and Cohen et al.'s Perceived Stress Questionnaire (1983). Also, the research data will be analyzed using SPSS version 27 computer software.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The present study, due to the random selection and replacement of participants, is a field experimental study and a pre-test-post-test research design with a control group and a follow-up phase. In this design, the subjects are measured before the implementation of the independent variable (pre-test), then the experimental intervention or independent variables are applied. After that, the subjects are measured again. Finally, after one month from the post-test, both groups are measured again to examine the continuity of the effect of the interventions on the experimental groups. To select the sample to test the hypotheses, students whose test anxiety level in the Spielberger Test Anxiety Inventory was one standard deviation above the mean in the previous stage and who also showed symptoms of test anxiety in the clinical interview were selected by simple random selection to participate in the study. Then, these individuals will be randomly divided into 2 groups of 20 (20 in the experimental group and 20 in the control group). After forming the groups, the subjects were led to special rooms and were given questionnaires to measure the variables as a pre-test and were assured that the answers they gave would remain confidential. They were asked to answer the questions confidently and honestly. Mindfulness-based stress reduction therapy sessions were developed based on the Kabat-Zinn method (2013) and were implemented in 8 90-minute sessions, two sessions per week for 1 month. After completing the treatment period, the experimental group was re-assessed with questionnaires to measure the variables as a post-test and finally, after one month of the post-test, they were re-assessed (follow-up phase).
Category
Treatment - Other

2

Description
Control group: The present study, due to the random selection and replacement of participants, is a field experimental study and a pre-test-post-test research design with a control group and a follow-up phase. In this design, the subjects are measured before the implementation of the independent variable (pre-test), then the experimental intervention or independent variables are applied. After that, the subjects are measured again. Finally, after one month from the post-test, both groups are measured again to examine the continuity of the effect of the interventions on the experimental groups. To select the sample to test the hypotheses, students whose test anxiety level in the Spielberger Test Anxiety Inventory was one standard deviation above the mean in the previous stage and who also showed symptoms of test anxiety in the clinical interview were selected by simple random selection to participate in the study. Then, these individuals will be randomly divided into 2 groups of 20 (20 in the experimental group and 20 in the control group). It should be noted that the control group will not receive any intervention during the study. However, to prevent factors threatening the internal validity of the study, such as compensatory competition of the control group or demoralization, they will be assured that they will receive mindfulness-based stress reduction training in the next session (after data collection). After the groups were formed, the subjects were led to special rooms and given questionnaires to measure variables as a pre-test and were assured that their answers would remain confidential. They were asked to answer the questions confidently and honestly. After the end of the treatment period, the control group was re-assessed with questionnaires to measure variables as a post-test and finally, one month after the post-test, they were re-assessed (follow-up phase).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Primary schools in Essaouira, Iraq
Full name of responsible person
Safaa Tarek Zghair Aigaiawy
Street address
Unit 4, Ofogh Residential Complex, 3rd Sed and Sima St., Afarinesh St., Sadaf Blvd., Baharestan
City
Ahvaz
Province
Khouzestan
Postal code
6138643849
Phone
+98 61 3333 3333
Email
zarg3553@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pezhman Taghipour Birgani
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
Phone
+98 61 3333 3333
Email
p_taghipour@iauahvaz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Safaa Tarek Zghair Aigaiawy
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 4, Ofogh Residential Complex, 3rd Sed and Sima St., Afarinesh St., Sadaf Blvd., Baharestan
City
Ahvaz
Province
Khouzestan
Postal code
6138643849
Phone
+98 61 3333 3333
Email
zarg3553@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Safaa Tarek Zghair Aigaiawy
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 4, Ofogh Residential Complex, 3rd Sed and Sima St., Afarinesh St., Sadaf Blvd., Baharestan
City
Ahvaz
Province
Khouzestan
Postal code
6138643849
Phone
+98 61 3333 3333
Email
zarg3553@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Safaa Tarek Zghair Aigaiawy
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 4, Ofogh Residential Complex, 3rd Sed and Sima St., Afarinesh St., Sadaf Blvd., Baharestan
City
Ahvaz
Province
Khouzestan
Postal code
6138643849
Phone
+98 61 3333 3333
Email
zarg3553@gmail.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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