Investigating The effect of spiritual health education with family participation on quality of life related to the health of female adolescents
Design
A randomized controlled trial with parallel groups, one-sided randomized blind, on 60 adolescent girls aged 12-14 years, of which 30 were assigned to the control group and 30 to the intervention group. Simple randomization method will be used for randomization (lottery for each person)
Settings and conduct
8 sessions of 30-45 minutes of spiritual health training will be held at the health center, in person and virtually, for the intervention group, depending on the condition of the corona.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not participating in similar educational programs, adolescent girl in the age range of 14-14 years, no history of mental disorders or cognitive disorders, no drug addiction, adolescent living with her parents. Conditions of non-entry: Adolescent age is under 12 years. Adolescents participate in a similar training program at the same time. The teen is addicted. Adolescents have a history of mental or cognitive illness. Teenagers live alone.
Intervention groups
The effect of spiritual health education on health-related quality of life of adolescent girls aged 12-14 years in the intervention group and comparing the health-related quality of life score of this group with the control group who have not received spiritual health education.
Main outcome variables
Spiritual health education;
Overall health-related quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053621N1
Registration date:2022-03-02, 1400/12/11
Registration timing:prospective
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Zinat Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
rahimiz9@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-04-08, 1401/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual health education with family participation on quality of life related to the health of female adolescents
Public title
The effect of spiritual health education with family participation on quality of life related to the health of female adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescent girl in the age range of 12-14 years
Having written consent to participate in the study
Do not participate in similar training programs
No history of mental disorders and cognitive disorders
No drug addiction
Teenagers live with parents
Teens have a cell phone
Exclusion criteria:
Adolescents have a history of mental or cognitive illness
Teenagers are addicted
Teenagers live alone
Age
From 12 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 22 urban health centers of Mashhad Health Center No. 1, Sarafrazan Comprehensive Health Service Center will be selected as a test group based on purpose and available as an experimental group and x center will be selected as a control group after a simple lottery. (Due to the relationship between the adolescent girls of Sarafrazan Comprehensive Health Service Center and the possibility of information leakage, the control group was not selected from Sarafrazan Center itself). The lottery was such that the names of 22 urban centers covered by Health Center No. 1 were written on exactly the same sheets and placed in a box, then by removing one of the sheets, the center was identified as a control group. Then, in these two centers, the files of adolescent girls were reviewed and 30 people from each center, who are in the age range of 12-14 years, were randomly selected and after telephone or in-person counseling, with people who met the inclusion criteria. Necessary coordination will be made to attend the center.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, according to the type of intervention, which is an educational method, blindness cannot exist for participants as well as for evaluators. Blinding will only exist for statistical analysts.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
Mashhad School of Nursing and Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-02-11, 1400/11/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.089
Health conditions studied
1
Description of health condition studied
Assessing the quality of life related to the health of adolescent girls 12-14 years old
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life score related to adolescent girl health
Timepoint
The quality of life score is measured before, immediately and one month after the start of spiritual health education.
Method of measurement
Adolescent Health Quality of Life Questionnaire Kid Screen 27
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group, 30 adolescent girls 12-14 years old, in 8 sessions of 45 minutes, two sessions per week, which will last one month, spiritual health education (communication with God, communication with oneself, communication with others, communication with the world Creation) will be given according to the model of Razzaqi et al. This questionnaire will be filled in by the intervention group before the beginning of the trainings, immediately after the end of the trainings and one month after the end of the trainings.
Category
Other
2
Description
Control group: 30 adolescent girls aged 12-14 years who perform the usual educational activities of the school and at the end of the research, the educational materials provided for the intervention group are given to them in writing.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad number one health center
Full name of responsible person
zinat rahimi
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3589 1511
Email
rahimiz9@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zinat rahimi
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
rahimiz9@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
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
Mashhad University of Medical Sciences
Full name of responsible person
zahra emami moghadam
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
emamiz@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Emami Moghadam
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Emamiz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zahra emami moghadm
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
emamiz@mums.ac.ir
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
Data is shared after people are not identified.
When the data will become available and for how long
The access period will start immediately after the results are published.
To whom data/document is available
The data will be available for academic and scientific and... researchers.
Under which criteria data/document could be used
The data can be used for reference and further research.
From where data/document is obtainable
Mashhad School of Nursing and Midwifery - Tel: 05138591511
zahra Emami Moghaddam
What processes are involved for a request to access data/document
The applicant can access the data by visiting the library of Mashhad School of Nursing and Midwifery.