History
# Registration date Revision Id
2 2023-01-24, 1401/11/04 253799
1 2022-09-30, 1401/07/08 241572
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  • Protocol summary

    This study aims to test the effectiveness of a nurse-led resilience-training program on the psychological distress, resilience, and psychological well-being of school students in Oman.
    This study aims to test the effectiveness of a nurse-led resilience-training program on the psychological well-being, resilience, and coping behaviors of university students in Oman.
    Phase I: A cross-sectional descriptive correlational survey will be conducted to estimate the relationship between psychological distress, resilience, and psychological wellbeing of high school students. Phase II: True Experimental randomized controlled design with the wait-listed control group; with repeated measures for resilience and psychological distress, psychological wellbeing (baseline, 4 weeks, 8 weeks, and 12 weeks) will be carried out to evaluate the effectiveness of a nurse-led resilience training program on school student’s resilience, psychological distress, and psychological wellbeing.
    Phase I: A cross-sectional descriptive correlational survey will be conducted to estimate the relationship between psychological well-being, resilience, and coping behaviors of university students. Phase II: A quasi Experimental design with the wait-listed control group; with repeated measures for resilience and psychological distress, psychological well-being (baseline, immediately after the intervention and at 4 weeks) will be carried out to evaluate the effectiveness of a nurse-led resilience training program on student’s resilience, coping behaviors, and psychological wellbeing.
    Private and Government schools in Oman will be considered as the setting for the study. Private schools refer to schools catering education to Expatriate communities like Indian, Bangladeshi, Pakistani, and Philippines, and government school refers to schools catering education to Omani nationals and other nationals who can speak Arabic.
    Selected Private and Government universities of Oman
    Inclusion criteria 1. Students of classes 7th, 8th and 9th grade. 2. Willing to participate in the study. 3. Students identified as having low psychological well-being, low resilience, and psychological distress of mild and moderate level in the screening will be included in the intervention group. Exclusion criteria 1. Students with a known mental illness on treatment, identified from the school health records/ school health Nurse. 2. Students with severe psychological distress during screening; would be referred to a school health nurse or counselor.
    Inclusion criteria 1. university students in the first two years of their university life. 2. Willing to participate in the study. 3. Students identified as having low psychological well-being, low resilience, and poor coping behaviors in the screening will be included in the intervention group. Exclusion criteria 1. Students with a known mental illness on treatment, will be excluded during analysis.
    psychological wellbeing, psychological distress resilience
    psychological wellbeing, coping behaviors resilience
  • General information

    12
    18
    14
    35
    Randomized
    Not randomized
    empty
    As the school children are busy ministry of education suggested to do this study among university children.
    Effect of Resilience training program for school children
    Effect of Resilience training program for university students
    The effectiveness of a nurse led resilience-training program on psychological distress, resilience, and psychological well-being of school students in Oman
    The effectiveness of a nurse led resilience-training program on psychological wellbeing, resilience, and coping behaviours of university students in Oman
    1. Students of classes’ 7th, 8th and 9th grade.
    2. Willing to participate in the study.
    3. Students identified having low psychological wellbeing, low resilience and psychological distress of mild and moderate level in the screening will be included in the intervention group.
    1.university students in the first two years of university life
    2. Willing to participate in the study.
    3. Students identified as having low psychological wellbeing, low resilience and poor coping behaviors in the screening will be included in the intervention group.
    1. Students with a known mental illness on treatment, identified from the school health records/ school health Nurse.
    2. Students with severe psychological distress during screening; would be referred to school health nurse or counsellor.
    1. Students with a known mental illness on treatment, will be excluded in the analysis
    sealed Envelopes will be used for simple randomization to randomly either assign (1:1) each eligible school (cluster) to the intervention group or control group. The schools having 7th,8th and 9th-grade students will be randomly selected and each classroom will be considered as one cluster with 30-40 students. This is an open-label study and the study team will reveal the study group to participants after randomization. The sequence is given below. Sequence Treatment 1 Intervention group 2 Control group 3 Intervention group 4 Control group 5 Intervention group 6 Intervention group 7 Control group 8 Control group
  • Health conditions studied

    #1
    RESILIENCE IN HEALTHY SCHOOL CHILDREN
    RESILIENCE IN HEALTHY university students
  • Primary outcomes

    #1
    Nurse led resilience training will have an effect on the resilience of the healthy school children.
    Nurse led resilience training will have an effect on the resilience of the healthy univerisity students.
    0,4 weeks, 8 weeks and 12 weeks
    0,immediately after intervention, at 4 weeks
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Sri Ramachandra Institute of Higher Education and Research
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Santhi S
    Full name of responsible person - Persian:
    Position - English: Vice Principal
    Position - Persian:
    Latest degree: phd
    Area of specialty/work:
    Area of specialty/work title - English: Psychiatric Mental Health Nursing
    Area of specialty/work title - Persian:
    Street address - English: Porur, Chennai
    Street address - Persian:
    City - English: Chennai
    City - Persian:
    Province: Tamil Nadu
    Province - English: Tamil Nadu
    Province - Persian:
    contact.provinces_available:
    Country: India
    Postal code: 116
    Phone: +91 94442 78281
    Mobile: +91 94442 78281
    Fax:
    Email: santhi.s@sriramachandra.edu.in
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: COLLEGE OF NURISNG, SULTAN QABOOS UNIVERSITY
    Name of organization / entity - Persian:
    Full name of responsible person - English: DIVYA K Y
    Full name of responsible person - Persian:
    Position - English: LECTURER
    Position - Persian:
    Latest degree: master
    Area of specialty/work:
    Area of specialty/work title - English: PSYCHIATRIC MENTAL HEALTH NURISNG
    Area of specialty/work title - Persian:
    Street address - English: Al Khoud, CON,SQU
    Street address - Persian:
    City - English: MUSCAT
    City - Persian:
    Province: MUSCAT
    Province - English: MUSCAT
    Province - Persian:
    contact.provinces_available:
    Country: Oman
    Postal code: 123
    Phone: +968 9144 6631
    Mobile: +968 9144 6631
    Fax:
    Email: divyaky@squ.edu.om
    Web page address:

Protocol summary

Study aim
This study aims to test the effectiveness of a nurse-led resilience-training program on the psychological well-being, resilience, and coping behaviors of university students in Oman.
Design
Phase I: A cross-sectional descriptive correlational survey will be conducted to estimate the relationship between psychological well-being, resilience, and coping behaviors of university students. Phase II: A quasi Experimental design with the wait-listed control group; with repeated measures for resilience and psychological distress, psychological well-being (baseline, immediately after the intervention and at 4 weeks) will be carried out to evaluate the effectiveness of a nurse-led resilience training program on student’s resilience, coping behaviors, and psychological wellbeing.
Settings and conduct
Selected Private and Government universities of Oman
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. university students in the first two years of their university life. 2. Willing to participate in the study. 3. Students identified as having low psychological well-being, low resilience, and poor coping behaviors in the screening will be included in the intervention group. Exclusion criteria 1. Students with a known mental illness on treatment, will be excluded during analysis.
Intervention groups
1. as mentioned in the inclusion criteria above
Main outcome variables
psychological wellbeing, coping behaviors resilience

General information

Reason for update
As the school children are busy ministry of education suggested to do this study among university children.
Acronym
RTP
IRCT registration information
IRCT registration number: IRCT20220928056052N1
Registration date: 2022-09-30, 1401/07/08
Registration timing: registered_while_recruiting

Last update: 2023-01-26, 1401/11/06
Update count: 1
Registration date
2022-09-30, 1401/07/08
Registrant information
Name
DIVYA KUZHIVILAYIL YESODHARAN
Name of organization / entity
COLLEGE OF NURSING, SULTAN QABOOS UNIVERSITY
Country
Oman
Phone
+968 24 145482
Email address
divyaky@squ.edu.om
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a nurse led resilience-training program on psychological wellbeing, resilience, and coping behaviours of university students in Oman
Public title
Effect of Resilience training program for university students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1.university students in the first two years of university life 2. Willing to participate in the study. 3. Students identified as having low psychological wellbeing, low resilience and poor coping behaviors in the screening will be included in the intervention group.
Exclusion criteria:
1. Students with a known mental illness on treatment, will be excluded in the analysis
Age
From 18 years old to 35 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 250
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Ethics Committee, college of Nursing, Sultan Qaboos University
Street address
ALKHOUD
City
MUSCAT
Postal code
123
Approval date
2022-09-15, 1401/06/24
Ethics committee reference number
CON/NF/2022/11

Health conditions studied

1

Description of health condition studied
RESILIENCE IN HEALTHY university students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nurse led resilience training will have an effect on the resilience of the healthy univerisity students.
Timepoint
0,immediately after intervention, at 4 weeks
Method of measurement
self reported questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: nurse led training program group
Category
Prevention

2

Description
Control group: wait listed control group ; no intervention until the data collection is complete, the training is given
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Muscat Governorate
Full name of responsible person
DIVYA K Y
Street address
Al Khoud, CON,SQU
City
MUSCAT
Postal code
123
Phone
+968 9144 6631
Email
divyaky@squ.edu.om

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sultan Qaboos University
Full name of responsible person
Dr Sulaiman Al-Sabei
Street address
Al Khoud, Muscat
City
Muscat
Postal code
123
Phone
+968 9441 1630
Email
alsabei@squ.edu.om
Grant name
NA
Grant code / Reference number
NA
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NA
Proportion provided by this source
100
Public or private sector
Private
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
COLLEGE OF NURISNG, SULTAN QABOOS UNIVERSITY
Full name of responsible person
DIVYA K Y
Position
LECTURER
Latest degree
Master
Other areas of specialty/work
PSYCHIATRIC MENTAL HEALTH NURISNG
Street address
Al Khoud, CON,SQU
City
MUSCAT
Province
MUSCAT
Postal code
123
Phone
+968 9144 6631
Email
divyaky@squ.edu.om

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Nursing, Sultan Qaboos University
Full name of responsible person
Dr Judie Arulappan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Maternal and Child Health
Street address
Al Khoud, Muscat
City
Muscat
Province
Muscat
Postal code
123
Phone
+968 9563 1235
Email
judie@squ.edu.om

Person responsible for updating data

Contact
Name of organization / entity
COLLEGE OF NURISNG, SULTAN QABOOS UNIVERSITY
Full name of responsible person
DIVYA K Y
Position
LECTURER
Latest degree
Master
Other areas of specialty/work
PSYCHIATRIC MENTAL HEALTH NURISNG
Street address
Al Khoud, CON,SQU
City
MUSCAT
Province
MUSCAT
Postal code
123
Phone
+968 9144 6631
Email
divyaky@squ.edu.om

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
there is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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