The study of the effectiveness of intervention on psychological well - being, the quality and quality of life of students at the University of Mashhad Medical Sciences University
The aim of this study was to evaluate the effectiveness of a positive intervention on psychological well-being, resilience and quality of life of dormitory students of Mashhad University of Medical Sciences.
Design
Clinical case trial in two groups of control and intervention, with parallel groups, one-way blind, randomized, on 53 people, using a random number table from www.randomization.com
Settings and conduct
This study will be conducted with the participation of dormitory students of Mashhad University of Medical Sciences. These individuals are selected by availability and participants will be selected according to the inclusion criteria. This process will continue until the sample size is completed in both groups. Divides intervention and control into two groups, A and B. When providing research information to the analyst, the analyst is unaware of this naming.
Participants/Inclusion and exclusion criteria
Enjoy psychiatric health (no psychiatric disorder) based on an initial interview with a clinical psychologist
Intervention groups
After determining the sample size, individuals are divided into control and intervention groups (intervention group is a group for which positive intervention is performed that 8 sessions of positive intervention will be performed for the intervention group in four weeks. The control group does not receive intervention) Only at the end of the project, a positive psychology training session will be held for them and a questionnaire on psychological well-being, quality of life and productivity will be taken.
Main outcome variables
Psychological well-being; Resilience; Quality of Life; Social Performance; Independence; Environmental dominance; Personal growth; Positive relationships with others; Limitations of students' feelings; Purposefulness in life; Self acceptance; Physical function; general health; Student vitality; mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201007048968N1
Registration date:2021-05-27, 1400/03/06
Registration timing:prospective
Last update:2021-05-27, 1400/03/06
Update count:0
Registration date
2021-05-27, 1400/03/06
Registrant information
Name
Masumeh Eshghizaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 3282
Email address
eshghizavehm3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effectiveness of intervention on psychological well - being, the quality and quality of life of students at the University of Mashhad Medical Sciences University
Public title
"The effectiveness of positive intervention on psychological well - being " "The effectiveness of positive intervention on resilience " "The effectiveness of positive intervention on quality of life "
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having psychiatric health (no psychiatric disorder) based on the initial interview
Be a student of Mashhad University of Medical Sciences
Be a resident of the dormitory at Mashhad University of Medical Sciences
Exclusion criteria:
The person is taking drugs or abusing drugs
The person has a psychiatric disorder
Graduated from the University of Medical Sciences
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
53
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a randomized clinical trial with a two-group control group of the study population is the dormitory students of Mashhad University of Medical Sciences (considering that there are students from different fields and sections on campus). The research units are based on a randomized list and are assigned to the intervention and control groups as one in between. The intervention groups will be 10 to 12 people. In the intervention group, 8 sessions of positive intervention training are taught according to the protocol of Seligman et al. During 4 weeks by a psychologist in the house of culture of the campus dormitory. Immediately after holding training sessions in the intervention group and also one month after completing the research tools in the first stage in the control group, both groups are asked to fill out a questionnaire on psychological well-being, resilience and quality of life. A training session will be held for the control group. At the end, the data will be analyzed using SPSS 16 software and the results will be reported.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher first divides the intervention and control groups into two groups, A and B. When the research information is provided to the analyzer, the analyzer is not aware of this naming.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Bu Ali Square, Ibn Sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.882
Health conditions studied
1
Description of health condition studied
The effectiveness of positivist intervention on psychological well-being the effectiveness of positivist intervention reflect the effectiveness of positivist intervention on quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Psychological well-being
Timepoint
At the beginning of the study (before the intervention) and immediately after the end of the training sessions
Method of measurement
Psychological well-being scale (short form):
2
Description
Resilience
Timepoint
At the beginning of the study (before the intervention) and immediately after the end of the training sessions
Method of measurement
Connor and Davidson water hydration questionnaire
3
Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention) and immediately after the end of the training sessions
Method of measurement
Psychological well-being (Reef), resilience questionnaire (Connor and Davidson), quality of life questionnaire (in two physical and mental dimensions)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Positive Psychology Training Program, an 8-session practical guide, will be implemented. The training will last for 4 weeks in the form of 8 2-hour sessions. The intervention is performed twice a week in groups of 10 to 12 people in three groups at a distance of two weeks from the previous group, which takes place at the House of Culture House on Mondays and Wednesdays from 2 to 4 pm. To teach positivity, the instructor will use lectures, PowerPoint, small group discussions, large group discussions, brainstorming, and homework. The main content of the educational intervention is determined by considering the texts in the books of positive psychology (Seligman's inner happiness book and Seligman's book of prosperity).
Category
Rehabilitation
2
Description
Control group: The control group does not receive any intervention. Only at the end of the project, a positive psychology training session is held for them and a
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling and Mental Health Center of Mashhad University of Medical Sciences
Full name of responsible person
Negar Asghari Pour
Street address
Azadi Square, Ferdowsi University of Mashhad, Old University of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3882 0047
Email
ZareiA4@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Azadi Square, Ferdowsi University of Mashhad, Old University of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3882 0047
Email
ZareiA4@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
Negar Asghari Pour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azadi Square, Ferdowsi University of Mashhad, University of Medical Sciences, Office Building (former School of Medicine)
City
mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3882 0047
Email
asgharipourn@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Negar Asghari Pour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azadi Square, Ferdowsi University of Mashhad, University of Medical Sciences, Office Building (former School of Medicine)
City
mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3882 0047
Email
asgharipourn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Eshghi Zaveh
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Fallahi Boulevard, Fallahi 11/38, No. 4, Unit 8
City
mashhad
Province
Razavi Khorasan
Postal code
9186175330
Phone
009836213282
Email
eshghizavehm3@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period 1 month after printing the results
To whom data/document is available
For the public
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Counseling and Mental Health Office of Mashhad University of Medical Sciences, Contact Number 05138820047
What processes are involved for a request to access data/document
Send a request by email to the person in charge of the scientific respondent