Protocol summary

Study aim
Determining the effect of implementing a program to promote the spiritual health of stress and loneliness of high school girls in Gorgan in the year 1400
Design
This study has two groups of control and intervention. The sample size is 30 students for the intervention group and 30 students for the control group. In this study, the study plan is parallel.
Settings and conduct
Spiritual self-care training will be conducted on 30 teenage female students in a WhatsAp virtual group.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Age group 14 to 16 years 2. Sex of the girl 3. Achieve a score of at least 140 and above the stress criterion 4. Achieve a score of at least 40 or higher from the criterion of feeling lonely 5. No psychiatric disorder or use of psychiatric medication Exclusion criteria 1. Occurrence of a stressful accident during the last 6 months 2. Not participating in two session
Intervention groups
In the intervention group, 8 sessions of 40 minutes (twice a week) of spiritual self-care training will be performed. In the control group, they do not receive training from the researcher and the procedure is performed routinely.
Main outcome variables
Feeling lonely Stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211011052733N1
Registration date: 2021-12-29, 1400/10/08
Registration timing: registered_while_recruiting

Last update: 2021-12-29, 1400/10/08
Update count: 0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Hamideh Rahnama Araghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
rahnamaha971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual self-care on Stress and loneliness in first grade high school girls
Public title
The effect of spiritual self-care on Stress and loneliness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age of adolescent between 14 to 16 years old. The gender of the girl Earn score 140 and above than Adolescent Stress Questionnaire (ASQ) . Earn score 40 and above than Usher and Haima and Renshaw Loneliness Questionnaire (1984)
Exclusion criteria:
History of used drug psychiatric. En Participate in the other psychological programs to the during the intervention.
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in cluster randomization. Gorgan has 12 high schools. One high school from each region will be selected randomly. In each high school, the participants will be selected as a quota for the population of that area and they will be contacted for research. In the second stage, stratified randomization will be divided into intervention and control groups. Because of the scatter of samples in each high school and also the possibility of heterogeneity in some of the basic features in the groups, the classified randomization program will be used. In this study, the samples were based on the high school centers
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 University of Mashhad Medical Sciences
Street address
Mashhad, Ibn Sina St.-doctora Four-Way
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-11-09, 1400/08/18
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.073

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Feeling lonely is an unpleasant condition that results from the difference between the relationship between the person that people tend to and the relationship that they have with others in real situations. This feeling is important because it is associated with both negative emotions and social poverty in adults, adolescents and children.
Timepoint
loneliness before the intervention, immediately after the intervention
Method of measurement
Usher and Haima and Renshaw Loneliness Questionnaire (1984)

2

Description
Stress
Timepoint
Stress before the intervention, immediately after the intervention
Method of measurement
Adolescent Stress Questionnaire (ASQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, after introducing the research and conducting the pre-test, 8 40-minute sessions (twice a week) of spiritual self-care sessions will be held. These interventions are in four areas: communication with God, communication with oneself, communication with others, and connection with the created world. The activities of the sessions will be: 1. Checking the pre-session assignments of the participants that have been assigned to them. 2. Giving feedback to the participants by the researcher 3. Listing and summarizing the previous material to make a connection between the discussed material and creating mental preparation of the participants for the new discussion 4. Doing new exercises 5. Giving homework for the next sessions 6 Explain the explanations and conclusions about the topic of the meeting. Codified trainings will be organized by the researcher in the form of lectures and webinars along with slide shows, group discussions in cyberspace and presentation of assignments.
Category
Behavior

2

Description
Control group: 30 Adolescent who will be randomly selected and will not receive any training, and completion of questionnaires will be conducted simultaneously with the intervention group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Grade high school girls
Full name of responsible person
Tahereh Sadeghi
Street address
Golestan Province, Gorgan, 24th Paradise, 41 missions
City
Gorgan
Province
Golestan
Postal code
9137913199
Phone
+98 51 3859 1513
Fax
+98 51 3859 1511
Email
Sadeghit@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghody
Street address
University Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vpresearch@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
Hamideh Rahnama Iraqi
Position
Master of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5700 2404
Email
Rahnamaha971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Rahnama Iraqi
Position
Master of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5700 2404
Email
Rahnamaha971@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Rahnama Iraqi
Position
Master of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5700 2404
Email
Rahnamaha971@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
Information about the outcome of the main message The ability to transfer the sharing
When the data will become available and for how long
One year after sharing results
To whom data/document is available
Our data will only be available to researchers working in academia.
Under which criteria data/document could be used
With the permission of Mashhad University of Medical Sciences, data will be available.
From where data/document is obtainable
Research Deputy of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
You must apply for deputy from Mashhad University of Medical Sciences
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