Protocol summary
-
Study aim
-
1_the effect of cognitive behavioral counseling based on mindfulness on anxiety about birth and newborn in nulliparous adolescents
2_the effect of cognitive behavioral counseling based on mindfulness on concerns about weight and body image in nulliparous adolescents
3_the effect of cognitive behavioral counseling based on mindfulness on anxiety about emotions and relationships in nulliparous adolescents
-
Design
-
A clinical trial with two intervention and control groups, without blinding, simple randomization, the intervention was conducted during 8 sessions on 66 people in the intervention group.
-
Settings and conduct
-
After identifying the pregnant adolescents with primiparous children in Kot Abdullah and Kayan health centers, if they met the criteria for participation in the study, the purpose of the research was explained to them. They were placed in two intervention and control groups. Both groups completed the pre-test and then 8 sessions of cognitive-behavioral counseling based on mindfulness were held for the intervention group during 8 weeks, and after the intervention, both groups completed the post-test.
-
Participants/Inclusion and exclusion criteria
-
Married teenagers who are first born and have a high anxiety score based on pregnancy anxiety questionnaire, if they wish, will enter the study after filling out a written consent form. Confirmed physical and mental problems in themselves or their spouse are the exclusion criteria for this study.
-
Intervention groups
-
The intervention group receives 8 sessions of 90-minute cognitive-behavioral counseling based on mindfulness, once a week, and finally its effect on concerns during pregnancy is evaluated.
-
Main outcome variables
-
Reducing concerns during pregnancy in nulliparous adolescents
General information
-
Reason for update
-
The sampling date was changed
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20250106064287N1
Registration date:
2025-01-08, 1403/10/19
Registration timing:
prospective
Last update:
2025-02-05, 1403/11/17
Update count:
2
-
Registration date
-
2025-01-08, 1403/10/19
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2025-01-20, 1403/11/01
-
Expected recruitment end date
-
2025-08-22, 1404/05/31
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The Effect of Cognitive-Behavioral Therapy Based on Mindfulness on Concerns of Nulliparous Adolescent Pregnant Women
-
Public title
-
Concerns during pregnancy of Nulliparous Adolescent
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
marriage
Adolescent 10 to 19 years old
first pregnancy
Gestational age of 20 weeks and above
Reading and writing literacy
High score based on pregnancy concerns questionnaire
Exclusion criteria:
Existence of severe physical problems
Having a history of mental illness confirmed by a psychiatrist in yourself or your spouse
Participation in other psychological training and counseling programs
Existence of high-risk conditions (diabetes mellitus and high blood pressure, etc.)
-
Age
-
From 10 years old to 19 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
66
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Eligible people will be selected for the study by available sampling method and then the participants will be divided into intervention and control groups using simple randomization method. The randomization method used in this study is the use of a table of random numbers. The table of random numbers is a collection of numbers that are generated without a specific pattern or order and completely randomly, and turned into a table. At first, the direction of reading numbers from the table was determined. The direction of reading numbers from the table of random numbers in this study. is from the left side, then the even numbers extracted from the table were assigned to the intervention group and the odd numbers extracted from the table were assigned to the control group. Each group consists of 33 participants.In this study, due to the nature of the interventions, it is practically not possible for the participants and the researcher to be blinded due to the knowledge of the participants about being in the intervention group and the training of the content of the sessions by the researcher, but the concealment of the random allocation by a central method and by another person will take place This ensures that there will be no bias in the selection of intervention and control groups and that the effects of the intervention will be evaluated accurately and fairly.
Blinding (according to the researcher)
Not blinded
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2024-12-21, 1403/10/01
-
Ethics committee reference number
-
IR.AJUMS.REC.1403.515
Health conditions studied
1
-
Description of health condition studied
-
Concerns during pregnancy
-
ICD-10 code
-
R45.82
-
ICD-10 code description
-
Worries
Primary outcomes
1
-
Description
-
Concerns during pregnancy
-
Timepoint
-
Before the start of the intervention, immediately after the end of the intervention sessions, 4 weeks after the end of the intervention
-
Method of measurement
-
Prenatal Distress Questionnaire
Intervention groups
1
-
Description
-
Intervention group: For the intervention group, 8 cognitive-behavioral counseling sessions based on mindfulness will be held during 8 90-minute sessions. In order to evaluate the results of the treatment, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention, and 4 weeks after the intervention. and will be used for statistical analysis
-
Category
-
Treatment - Other
2
-
Description
-
Control group: Control group: will receive usual care. In order to evaluate the treatment results, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention and 4 weeks after the intervention and will be used for statistical analysis
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
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
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
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
The data of the study are classified and coded so that the names of the people cannot be identified
-
When the data will become available and for how long
-
Access to the study data is possible after the results are published in the journal
-
To whom data/document is available
-
All people who want to use the data in this field can access the study data
-
Under which criteria data/document could be used
-
Study data can be used for comparison with other results
-
From where data/document is obtainable
-
Mrs. Mitra Tedin Najafabadi, a member of the academic faculty of Jundishapur University of Ahvaz
mitratadayon2000@yahoo.com
-
What processes are involved for a request to access data/document
-
The request is sent by e-mail to the person in charge of the scientific or general responsibility of the study
-
Comments
-