Protocol summary

Study aim
Determining the effect of spiritual skills training on health-related lifestyle in female adolescents
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on 60 healthy female adolescents. Lottery was used for randomization
Settings and conduct
Eight sessions of spiritual restraint training based on the model of spiritual health of Razzaqi et al. And the book of spiritual skills of Bualhari will be conducted in ordinary public schools
Participants/Inclusion and exclusion criteria
All adolescent girls 13 to 15 years old. Inclusion criteria: having written consent to participate in the study, not participating in similar educational programs. Does not have any mental or neurological diseases recorded in the health record. No entry: Parents involved in drugs, children being divorced, mourning first-degree relatives in the last 6 months
Intervention groups
In the intervention group, the training sessions will be in the form of discussion and presentation of the topic, questions and expressions of spiritual experiences by the adolescents, presentation of trainings, presentation of exercises to the participants. At the end of the session, the topics will be explained. 30 to 45 minute sessions will be presented twice a week. Training sessions will be performed in combination with face-to-face and virtual for the intervention group. Control group: In the control group, a questionnaire will be completed (before the study). Participants in the control group will perform routine school activities.
Main outcome variables
Health-related lifestyle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220529055017N1
Registration date: 2022-07-03, 1401/04/12
Registration timing: prospective

Last update: 2022-07-03, 1401/04/12
Update count: 0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Fahime Taghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
taghianf992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual skills training on health-related lifestyle in female adolescents
Public title
The effect of spiritual skills training on health-related lifestyle in female adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having written consent to participate in the study Do not participate in similar training programs Teenage girl in the age range of 13-15 years Does not have any mental or neurological diseases recorded in the health record
Exclusion criteria:
Having parents involved with drugs Being a child of divorce Having a known physical or mental problem Mourning first-degree relatives in the last 6 months
Age
From 13 years old to 15 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
First, the researcher, in coordination with the Department of Education, will select a region from among the 7 districts of Mashhad at random, a list of the first secondary schools for girls in the same district will be prepared, and then 4 schools from the normal public schools. It is selected randomly and estimated from each school according to the sample size and based on the inclusion criteria, 15 girls will be systematically selected randomly.
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 Mashhad School of Nursing and Midwifery
Street address
Mashhad School of Nursing and Midwifery, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-05-29, 1401/03/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.O15

Health conditions studied

1

Description of health condition studied
Healthy adolescent
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Health-related lifestyle
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
Adolescent Health Lifestyle Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Spiritual skills training based on the book of spiritual health of Razzaqi et al. As well as the book of spiritual skills of Boalhari et al. Will be done in 8 sessions of 30 to 45 minutes and two sessions a week for the adolescents of the intervention group. In addition to the intervention, the adolescents in the intervention group benefit from religious and routine religious activities and occasions.
Category
Prevention

2

Description
Control group: The control group will also complete a questionnaire (before the study). Participants in the control group will perform routine school activities such as holding religious meetings and regular parenting activities. The materials presented to the intervention group will be delivered to the control group at the end.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls' secondary schools
Full name of responsible person
Fahime Taghian
Street address
Imam Khomeini street
City
Tabas
Province
South Khorasan
Postal code
9791888167
Phone
+98 56 3283 2150
Fax
Email
taghianf992@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarahan
Street address
Doctoral Crossroads, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
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
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Taghian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
taghianf992@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghme razaghi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00985951113851
Email
razaghin@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Taghian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
taghianf992@mums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...