Implementation and Evaluation of an Internet-Based Stress Management Program for Health Students in the Sfax Region
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Perceived Stress Level in Health Students
研究概览
简要总结
The objective of this experimental study (randomized controlled trial) is to evaluate the effectiveness of an internet-based stress management program, inspired by the French program "Je gère mon stress," among healthcare students in Sfax, Tunisia.
The target population includes all healthcare students over 18 years old, from any field (paramedical, nursing, medicine, etc.), regardless of their baseline level of perceived stress.
The main questions this study aims to answer are:
Does the online program significantly reduce the level of perceived stress (measured using the Perceived Stress Scale - PSS-10)? Does the program have a beneficial impact on symptoms of anxiety and depression (measured with the Hospital Anxiety and Depression Scale - HADS)? Does it improve sleep quality (assessed using the Pittsburgh Sleep Quality Index - PSQI)?
Comparison group:
Researchers will compare the outcomes of the intervention group (who will access the online stress management program for 8 weeks) with those of the control group (waiting list, no initial access), to evaluate the specific effects of the program.
Participants will:
Complete three validated questionnaires (PSS-10, HADS, and PSQI) before and after the intervention; Be invited to follow a weekly series of psychoeducational modules over 8 weeks, including short educational videos, breathing techniques, guided relaxation, and practical exercises, all accessible through a secure web platform; Receive weekly motivational messages to support engagement.
详细描述
This randomized controlled trial aims to assess the effectiveness of an internet-based stress management program tailored for healthcare students in Sfax, Tunisia. The intervention is an adaptation of the validated French program "Je gère mon stress," redesigned to fit the local sociocultural context.
The study targets healthcare students aged 18 and above, from various disciplines (nursing, physiotherapy, midwifery, anesthesia, etc.), regardless of their baseline perceived stress levels.
Participants in the intervention group will receive access to an 8-week structured online program composed of:
Weekly psychoeducational video capsules (covering stress mechanisms, coping strategies, relaxation techniques, etc.), Guided breathing and relaxation exercises, Simple cognitive-behavioral tools, Time management and lifestyle advice.
All participants will be assessed at baseline (pre-intervention) and post-intervention using three validated instruments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Complete participant blinding was not feasible given the behavioral nature of the digital intervention, as participants were necessarily aware of their group allocation. Outcome data were collected via automated self-administered online questionnaires, precluding assessor bias. The randomization sequence was concealed from the doctoral candidate coordinating the intervention throughout the study period. The original registration entry indicating quadruple blinding is hereby corrected to reflect actual blinding procedures implemented.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The target population includes all students enrolled in the third year at the Higher Institute of Nursing Sciences (ISSIS) and the Higher School of Health Sciences and Techniques (ESSTSS) for the 2025-2026 academic year.
- •Own a smartphone, tablet, or computer.
- •Have internet access.
- •Have an email address.
- •Be willing to be randomized.
- •Have given informed consent to participate in the study.
- •Be available and committed to completing the entire online intervention program and participating in all evaluations.
排除标准
- •Current enrollment in another stress management program;
- •History of chronic psychiatric illness;
- •Current use of anxiolytic or psychotropic medication.
研究组 & 干预措施
Groupe I
Participants in the intervention group will receive an email containing their login credentials (username and password) to access the website and actively participate in the scheduled sessions of the program. Upon logging in, they will watch a short introductory video of about five minutes explaining how the program works. They will then answer three follow-up questions to confirm their understanding. If any answers are incorrect, they will be asked to rewatch the video until all questions are correctly answered.
Next, participants will receive an information letter explaining the requirement to visit the website at least once a week for a minimum of 30 minutes per session, with the option to spend more time or visit more frequently if they wish. After successfully answering the questions, they will be asked to provide informed consent ensuring the security and confidentiality of their personal data before accessing the sessions.
This initial step is crucial for the success of the p
干预措施: Online Stress Management Program (Behavioral)
Groupe C
Participants in the control group will receive an email informing them of their assignment. They will have access to the website after 12 weeks. They will be asked to refrain from any stress management activities (such as yoga, meditation, etc.) during this period.
结局指标
主要结局
Perceived Stress Level in Health Students
时间窗: At baseline (week 0), at the end of the program (week 8), one month post-intervention (week 12), and six months post-intervention (approximately week 34)
This measure assesses participants' perceived stress intensity before and after the intervention using a validated tool such as the Perceived Stress Scale (PSS). It quantifies changes in stress management and evaluates the program's impact on students' psychological well-being. Follow-up assessments were conducted one month and six months after the program ends to evaluate the durability of treatment effects.
Perceived Stress Level in Health Students
时间窗: At baseline (week 0), at the end of the program (week 8), and one month post-intervention (week 12)
This measure assesses participants' perceived stress intensity before and after the intervention using a validated tool such as the Perceived Stress Scale (PSS). It quantifies changes in stress management and evaluates the program's impact on students' psychological well-being.Follow-up assessment will also be conducted one month after the program ends to evaluate the long-term effects.
次要结局
- Anxiety and Depression Levels (HADS) and Sleep Quality (Pittsburgh Sleep Quality Index)(At baseline (week 0), at the end of the program (week 8), one month post-intervention (week 12), and six months post-intervention (approximately week 34))
- Anxiety and Depression Levels (HADS) and Sleep Quality (Pittsburgh Sleep Quality Index)(At baseline (week 0), at the end of the program (week 8), and one month post-intervention (week 12))
研究者
Ines KHARRAT
Principal Investigator
University of Sfax