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Investigating the effectiveness of Mindfulness Based Stress Reduction(MBSR) through artificial intelligence on anxiety and pain caused by primary dysmenorrhea in the students of Medical Sciences

Protocol summary

Study aim
Determining the effectiveness of mindfulness-based stress reduction counseling through artificial intelligence on anxiety and pain caused by primary dysmenorrhea
Design
The study includes an intervention group and a control group, which are determined through block randomization. The intervention group will undergo mindfulness-based stress reduction counseling through artificial intelligence. The sample size in this study is 66 people for each group.
Settings and conduct
The target population of this study is students of Kerman University of Medical Sciences living in the dormitory. In the intervention group, mindfulness counseling will be provided for 8 sessions in the form of photos, clips, and podcasts through artificial intelligence. In this study, an application will be designed that consists of two parts, the first part provides educational content and mindfulness counseling exercises, and the second part acts as a virtual coach through which the individual can ask their questions and get answers or receive guidance regarding the counseling program.
Participants/Inclusion and exclusion criteria
Students studying at Kerman University of Medical Sciences, aged 18-35 years, no known physical or mental illness or use of anti-stress, anxiety and depression medications (according to the participant's statement), no known chronic pelvic disease (according to the participant's statement), no surgery in the past 3 months, no use of birth control pills, painkillers and other herbal medicines, as well as relaxation or acupressure to relieve primary dysmenorrhea, onset of dysmenorrhea before the age of 20 and regular menstrual cycles with intervals of 21-35 days, mild to moderate pain intensity with a score of 4 to 8.
Intervention groups
Students studying at Kerman University of Medical Sciences, age 18-35 years
Main outcome variables
Anxiety reduction Pain reduction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250909067200N1
Registration date: 2025-09-21, 1404/06/30
Registration timing: prospective

Last update: 2025-09-21, 1404/06/30
Update count: 0
Registration date
2025-09-21, 1404/06/30
Registrant information
Name
fatemeh behnam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 926 6275
Email address
bhnamfatmh468@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-11, 1404/07/19
Expected recruitment end date
2025-10-21, 1404/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Mindfulness Based Stress Reduction(MBSR) through artificial intelligence on anxiety and pain caused by primary dysmenorrhea in the students of Medical Sciences
Public title
Investigating the effectiveness of Mindfulness Based Stress Reduction(MBSR) through artificial intelligence on anxiety and pain caused by primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a known physical or mental illness or using anti-stress medications Absence of anxiety and depression No known chronic pelvic disease No surgery within the past three months Avoid using birth control pills, painkillers, and other herbal medicines, as well as relaxation or acupressure to relieve primary dysmenorrhea. Dysmenorrhea onset before age 20 and regular menstrual cycles with intervals of 21-35 days Mild to moderate pain intensity with a score of 4 to 8
Exclusion criteria:
Unwillingness to cooperate Having a known physical or mental illness or using anti-stress medications Having severe pain, scoring higher than 8 Dysmenorrhea starting after age 20 or having irregular menstrual cycles Using birth control pills, painkillers, and other herbal remedies, as well as relaxation techniques or acupressure to relieve primary dysmenorrhea History of surgery in the past three months Having a known chronic pelvic disease Suffering from anxiety and depression
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
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 Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2025-09-05, 1404/06/14
Ethics committee reference number
IR.KMU..REC.1404.295

Health conditions studied

1

Description of health condition studied
Primary Dysmenorrhea
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle

Primary outcomes

1

Description
Anxiety
Timepoint
Before and two weeks after the start of the intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory

2

Description
Pain
Timepoint
Before and two weeks after the start of the intervention
Method of measurement
Pain intensity questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mindfulness-based stress reduction counseling through artificial intelligence
Category
Treatment - Other

2

Description
Control group: During the study, people in the control group do not undergo any intervention and can only use medication if they are unable to tolerate pain. If it is not possible to make adjustments between drug users in the control and intervention groups, those people will be removed from the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Reyhaneh Dormitory, Kerman University of Medical Sciences
Full name of responsible person
Hossein Kalami
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kalami.hossein@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Hamid Sharifi
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
hsharifi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Behnam
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shiraz Blvd, Hafezieh Ave, No 10
City
Kerman
Province
Kerman
Postal code
7619699189
Phone
+98 935 926 6275
Fax
Email
bhnamfatmh468@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Firuzeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Behnam
Position
Non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shiraz Blvd, Hafezieh Ave, No 10
City
Kerman
Province
Kerman
Postal code
7619699189
Phone
+98 935 926 6275
Fax
Email
bhnamfatmh468@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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