The effect of counseling with cognitive-behavioral approach on anxiety and stress and quality of life of mothers of girls with early onset of puberty symptoms: a quasi-experimental study
The effect of cognitive counseling on anxiety and stress and quality of life
Design
A randomized controlled clinical trial with two parallel arms
Settings and conduct
This study will be performed in Tabriz primary schools on 60 mothers who have daughters with early puberty symptoms. Mothers will be evaluated according to the eligible criteria and if they have the criteria and desire to participate in the study, informed written consent will be obtained and initial assessments will be made. Participants will be assigned to the intervention and control groups using a random blocking method with the size of 4 and 6 blocks with a 1: 1 allocation ratio.
Participants/Inclusion and exclusion criteria
conditions of entrance:
1. Mothers having daughters with the onset of puberty praecox symptoms by the score 35-65 of anxiety in the Spiel berger Anxiety Questionnaire and a score aver 21.8 in the Perceived Stress Questionnaire, has been studied.
2.Mothers with at least guidance school literacy
3. Having a daughter under10 year old.
Criteria for non-entry to study:
1. Having a history of mental disease according to the version of person himself
2- Experience of a severe mental crisis during the last 3 months, such as the death of relatives according to the version of person himself
3-taking the neuroleptics drugs by mothers
4- Mothers having physically and mentally other problems.
5- Participation in other similar studies
Intervention groups
For the intervention group, group counseling with a cognitive-behavioral approach will be held in 8 sessions of 45 to 60 minutes, once a week. An educational booklet is provided for the control group.
Main outcome variables
Average score of anxiety and stress and quality of life
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20110826007418N6
Registration date:2021-10-11, 1400/07/19
Registration timing:prospective
Last update:2021-10-11, 1400/07/19
Update count:0
Registration date
2021-10-11, 1400/07/19
Registrant information
Name
Parisa Yavarikia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
yavarikiap@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-12, 1400/07/20
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with cognitive-behavioral approach on anxiety and stress and quality of life of mothers of girls with early onset of puberty symptoms: a quasi-experimental study
Public title
The effect of counseling with cognitive-behavioral approach on anxiety and stress and quality of life of mothers of girls with early onset of puberty symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having daughter with the age under 10 year
Mothers with at least guidance school literacy
Having a daughter with onset of pubertats praecox symptoms
Exclusion criteria:
Having a history of mental disease according to the version of the person himself.
Experience of a severe mental crisis during the last 3 months, such as the death of relatives, according to the version of the person himself.
using the neuroleptics drugs by mothers.
Mothers who have had physically and mentally other problems
Participation in other similar studies
Age
From 7 years old to 10 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two intervention groups (receiving cognitive-behavioral counseling) and the control group by random blocking method with 4 and 6 block sizes and 1: 1 allocation ratio. To conceal the type of intervention, it will be written on a piece of paper and numbered in a series of opaque envelopes. The envelopes will be opened in the order in which the participants enter the study and the type of group will be determined. Random allocation and preparation of envelopes will be done by a person not involved in sampling and data collection.
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 Tabriz University of Medical Sciences
Street address
South Shariati St. - School of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.TBZMED.REC.1400.227
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
3
Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description
Quality life
Primary outcomes
1
Description
Stress
Timepoint
Before and after the intervention
Method of measurement
Perceived stress questionnaire
2
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
Spiel berger Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
SF36 questionnaire
Intervention groups
1
Description
Intervention group: 8 sessions of cognitive-behavioral counseling for 45-60 minutes once a week in a quiet environment and in groups (5 to 7 people in each group) will be held. The content of these sessions includes initial psychological assessment, rearrangement of concepts, use of clinical skills, strengthening of skills and how to use them, generalization and maintenance, follow-up and evaluation after the intervention.
Category
Behavior
2
Description
Control group: The participants of the control group will receive an educational booklet on puberty and health issues during this period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools of Tabriz
Full name of responsible person
Faranak Rahimi
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 45 3252 8957
Email
faranak.rahimi94@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
research deputy,third floor, central building No:2 tabriz university of medical sciences, Golgasht avenue, azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Faranak Rahimi
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
faranak.rahimi94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavarikia
Position
Masters
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 1479 6770
Email
yavarikiap@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavarikia
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati St., School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 1479 6770
Email
yavarikiap@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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