The application of a stress management program among Health Science Center students at Kuwait University

ISRCTN ISRCTN12883314
DOI https://doi.org/10.1186/ISRCTN12883314
Secondary identifying numbers HSCKU1
Submission date
09/11/2024
Registration date
12/11/2024
Last edited
06/06/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The purpose of this research is to study the effectiveness of a stress management program among students at the Health Science Center (HSC), Kuwait University.

Who can participate?
Health Science students, HSC, Kuwait University

What does the study involve?
In this study, participants will be randomly assigned to one of two groups: (1) the control group or (2) the experimental (intervention) group. The participants receive a comprehensive educational seminar relevant to stress management (i.e., a presentation, written hand-outs and a structured home program). The seminar addresses nine topics pertaining to stress management strategies: breathing and imagery techniques; self-care routines; planning for success; meditation strategies; monitoring mechanisms for coping; seeking help for mental health, exercise and health; cognitive behavioral therapy tips (CBTs); and psychoeducation. The whole stress management program takes about one month.

Ethical approval will be obtained from the local institutional review board. Students will be invited to participate in the study through a QR code and a WhatsApp group. The purpose of the study will be explained to the students, and informed consent will be obtained. Confidentiality will be assured. Prior to random allocation, the participants will be contacted through an online form and asked to complete the online Depression Anxiety and Stress Scale-21 (DASS-21) and Perceived Stress Scale (PSS). At the end of the scale, the participants will be asked if they are willing to participate in the stress management programs. After participating in the stress management program, all participants will be asked to complete the scales again.

What are the possible benefits and risks of participating?
After participating in the stress management program, the study participants are expected to have significantly improved psychological symptoms including stress, anxiety and depressive symptoms. No risks are expected and confidentiality is assured.

Where is the study run from?
Kuwait University

When is the study starting and how long is it expected to run for?
October 2023 to May 2024

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr. Naser Mohammed Alotaibi, naser.alotaibi@ku.edu.kw

Contact information

Dr Naser Alotaibi
Public, Scientific, Principal Investigator

655 st, block 6, building 25
Jaber Alahmed
91716
Kuwait

ORCiD logoORCID ID 0000-0002-2591-2511
Phone 00965-99191253
Email naser.alotaibi@ku.edu.kw

Study information

Study designQuasi-experimental study design
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Internet/virtual, Telephone, University/medical school/dental school
Study typeEfficacy
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleThe application of a stress management program among Health Science Center (HSC) students at Kuwait University: A quasi-experimental study
Study acronymStress Management Program
Study objectivesIt is hypothesized that introducing a stress management program tailored to the culture of Health Science Center (HSC) students at Kuwait University will significantly decrease stress and depression levels compared to a control group.
Ethics approval(s)

Approved 10/01/2024, Health Science Center Ethical Committee (P.O. box 24923 Safat, Kuwait City, 13110, Kuwait; +96524636203; hsc.ethicalcommitee@ku.edu.kw), ref: 580

Health condition(s) or problem(s) studiedPsychological symptoms (i.e. stress, anxiety and depressive symptoms)
InterventionThe intervention involves the self-administration of a stress management program for 4 weeks that was developed by three faculty members from the occupational therapy and physical therapy departments.

The study used a quasi-experimental design conducted at Kuwait University, Kuwait. A quasi-experimental design was used, as a true randomized process was not
performed. In other words, not all HSC students had the same chance of being selected because we did not have a complete list of all HSC students to choose from. This led to selection bias based only on the available HSC students, where random assignment was used only within a preexisting cohort. The participants will be randomly assigned to one of two groups: (1) the control group or (2) the experimental (intervention) group.

Students will be invited to participate in the study through a QR code and a WhatsApp group. The purpose of the study will be explained to the students, and informed consent obtained. Confidentiality is assured. Before random allocation, the participants will be contacted through an online form and asked to complete the online Depression Anxiety and Stress Scale-21 (DASS-21) and Perceived Stress Scale (PSS). At the end of the scale, the participants will be asked if they are willing to participate in the stress management programs. After participating in the stress management program, all participants will be asked to complete the survey again.

Intervention program (stress management program)
An orientation session and an educational seminar for the participants will be provided before starting the program, this will thoroughly explain and elaborate on the intervention by the faculty members to the experimental group. The stress management program includes three elements: (1) an oral presentation, (2) a booklet, and (3) a structured home program. The program content included the following components (intervention strategies): breathing and imagery techniques; self-care routine; planning for success; meditation strategies; monitoring mechanisms for coping; seeking help for mental health; exercise and health; cognitive behavioral therapy tips; and, psychoeducation.
Intervention typeBehavioural
Primary outcome measure1. Symptoms of depression, anxiety, and stress measured using the Depression Anxiety and Stress Scale-21 (DASS-21) at baseline and week 4
2. The perception of stress measured using the Perceived Stress Scale (PSS-10) at baseline and week 4
Secondary outcome measuresThe perceptions of the intervention (stress management) program in the experimental group measured using a study questionnaire (3-point Likert scale) at week 4
Overall study start date12/10/2023
Completion date01/05/2024

Eligibility

Participant type(s)Learner/student
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexBoth
Target number of participants240
Total final enrolment98
Key inclusion criteria1. Students from the HSC faculties, including medicine, dentistry, pharmacy, and allied health
2. 18 years of age and older
3. Had studied for two to seven years
Key exclusion criteria1. Students from other faculties at Kuwait University
2. First-year students
Date of first enrolment01/02/2024
Date of final enrolment01/05/2024

Locations

Countries of recruitment

  • Kuwait

Study participating centre

Health Science Center, Kuwait University
P.O. Box 31470
Sulaibekhat
90805
Kuwait

Sponsor information

Kuwait University
University/education

P.O. Box 31470
Kuwait City
90805
Kuwait

Phone +9654980000
Email hsc.ethicalcommitee@ku.edu.kw
Website https://www.ku.edu.kw/
ROR logo "ROR" https://ror.org/021e5j056

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Naser Mohammed Alotaibi, naser.alotaibi@ku.edu.kw. Study data that support the findings of this study are not openly available for reasons of sensitivity.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 12/05/2025 06/06/2025 Yes No

Editorial Notes

06/06/2025: Publication reference added.
12/11/2024: Study's existence confirmed by the Ethics Committee of Kuwait University.