Determining the effect of mindfulness-based counseling on the inactivity of adolescent girls
Design
The clinical trial has a randomized control group, an intervention and a control group of 67 people each, the type of randomization was block randomization with the size of 4.
Settings and conduct
The place of the study is girls' high schools in Ahvaz city. The sample of the research is tenth grade students who meet the conditions to entering the study. The participants are randomly assigned to two control and intervention groups.there is no possibility of blinding in this study. In the control group, there is no intervention, and in the intervention group, the counseling based on mindfulness is used. The treatment program will be provided by the researcher in the form of an 8-session program(two sessions per week). Meetings will be held in groups. Contents and assignments will be presented to the intervention group on a weekly basis. The way to follow up the samples in 3 stages is to fill the questionnaire in the first session (pre-test), the last session (post-test) and one month after the last training session.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Living together with parents,Written parental consent, Teenager's willingness to cooperate and participate in meetings, Age range from 14 to 16 years, Physical and mental health
Exclusion criteria: Suffering from any severe physical or mental illness that prevents physical activities, Reluctance to participate in the study, Receiving any psychological services during the last 6 months
Intervention groups
Participants are randomly assigned to two control and intervention groups. There is no intervention in the control group and counseling based on mindfulness is used in the intervention group.
Main outcome variables
Inactivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230728058952N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
ُSheida Momtaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 4867
Email address
sheidamom2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based counseling on the inactivity of adolescent girls
Public title
The effect of mindfulness-based counseling on the inactivity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Living together with parents
Written parental consent
Teenager's willingness to cooperate and participate in meetings
Age range from 14 to 16 years
Physical and mental health
Low or moderate physical activity based on the physical activity questionnaire of children and adolescents (Score 1 to 3.66)
Exclusion criteria:
Suffering from any severe physical or mental illness that prevents physical activities.
Reluctance to participate in the study
Receiving any psychological services during the last 6 months
Any use of psychiatric drugs and addictive substances
Age
From 14 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, considering that we have two intervention and control groups, we will use a block of 4. In order to determine the allocation sequence using the 4 block method, random allocation sequence generation software (Random Allocation Software 2.0) will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of research and technology, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.AJUMS.REC.1402.196
Health conditions studied
1
Description of health condition studied
inactivity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
inactivity
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
International physical activity questionnaire for children and adolescents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: adolescent girls receiving mindfulness-based counseling. Mindfulness-based counseling uses mindfulness meditation practices and psychological strategies.In this method, mindfulness is based on 4 principles including Body awareness (body position and body movement/activity), body sensations (including those related to emotions), mental states (including emotional states) and mental content (thoughts, images) are taught. Before starting the treatment program, the training certificate of the mindfulness course will be received and attached to the study, then the mindfulness-based counseling program for inactivity in the form of an 8-session program during 8 weeks by The researcher will be presented. Meetings will be held in groups. Contents and assignments will be presented to the people of the intervention group on a weekly basis. It will be considered that the participants, whenever they have a problem in doing the assignments, have more interaction with the researcher in person or virtually to ensure the correctness of the assignments.
Category
Treatment - Other
2
Description
Control group: Adolescent girls without receiving mindfulness-based counseling
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Education Department of Ahvaz city
Full name of responsible person
Massoud Hamidinejad
Street address
Basij Square, Khorram St
City
Ahvaz
Province
Khouzestan
Postal code
63333363055
Phone
+98 61 3333 4019
Email
Khouz.pr@chmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahand Jorfi
Street address
Deputy of research and technology, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
jorfi-s@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
mojganjavadnoori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan javadnoori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
mojganjavadnoori@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
mojganjavadnoori@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
It will be possible to access the research documents six months after the final statistical analysis.
To whom data/document is available
The data will be available only for the use of researchers of academic institutions
Under which criteria data/document could be used
In order to improve the health of adolescents
From where data/document is obtainable
In order to receive the data, people can refer to the main executive of the project, Dr. Mojgan Javadnoori, a member of the academic staff of Jundishapur University of Medical Sciences, Ahvaz. Email: mojganjavadnoori@gmail.com
What processes are involved for a request to access data/document
After obtaining the necessary permits from the Jundishapur University of Medical Sciences and the Vicechancellor of Research and Technology of this university, the applicant can proceed to receive the documents.