Study design and procedure
psychiatric, stress reduction
SESSION, EVENTS, RECRUITMENT, STRESSFUL EVENTS
This stratified randomized study was designed with pre-test (time 0), post-test (time 1), and follow-up measurements (time 2). The target population was medical students at KSU, which is a governmental medical school, and Vision private colleges in Riyadh, Saudi Arabia. The college of medicine at King Saud University offers medical education over a period of 6 years where the first two years tackle basic medical sciences and the next 3 years reserved for clinical education and bedside teaching. The curriculum relies greatly on lectures, problem-solving sessions, and bedside teaching. Passing the last year of internship training is required before receiving the Bachelor of Medicine, Bachelor of Surgery (MBBS). There was a shift to online education during the COVID-19 pandemic. The medical college in Vision private colleges share similar education system. A sample size calculation concluded that at least 37 participants per group would be required to detect a mean difference of 2 in our primary outcome which was the perceived stress scale (PSS), with a power of 90% at a significance level of 0.05. The sample size was increased to 42 subjects per group to compensate for possible dropout. Participants were recruited between November 2018 and April 2021 on a voluntary basis. We invited the students to participate through advertising lectures and brochures, after the IRB approval for the content of that lecture and the brochure. We announced the lecture through the student council. It was conducted by one of the research team members, who is a consultant and associate professor in psychiatry. Before the COVID-19 outbreak, it was an on-site lecture at King Saud University Medical School and Vision Colleges. Then the lecture was repeated online during the pandemic to recruit more candidates. The lecture aimed to increase the awareness of stress and its impact on the student’s well-being and offered evidence-based solutions to cope with it. Then it elaborated more on the concept of mindfulness, the aim of the study, and inclusion/exclusion criteria. The lecture ended up with a QR code to guide the students who are interested in joining the study to the invitation link to the study. The link collected the contact information of the candidates. Those who filled out the link were contacted, and if they fit the study’s criteria, we invited them to sign the consent form and answered their inquiries about the study. A brochure was also used to invite possible candidates through the student council database of students’ emails. In order to minimize the dropout, we discussed participants’ expectations before the study started, addressed their concerns, identified possible difficulties that could affect their participation.The inclusion criteria were current active status as medical student at Vision Colleges or KSU and willingness to participate and commit fully to the study. The exclusion criteria were inability to speak, read, and write in English, having any plans that could interfere greatly with the study adherence (such as surgical procedures or traveling), currently practicing meditation or involvement in any stress reduction program, and receiving any psychiatric treatment.There were 84 subjects who enrolled in the study after they consented, completed the pre-test measures, stratified randomization based on gender was used to allocate the 84 medical students to the study groups. The stratified randomization process was concealed and performed by an external party, two randomly generated lists using computer software were used to allocate males and females participants separately. There were 39 participants allocated to the MBSR group and 45 in the waitlist group. Ideally, the stratified randomization works better when all the subjects are available and enrolled at the same time. But in our case, the COVID-19 outbreak impacted the recruitment and we had to start with the consented participants and continue working to recruit more. We believed that we might lose our participants if we kept them waiting till we got our targeted sample size. So, the stratified randomization ended up with different numbers allocated in both groups. However, we reached the least required number in each group of the calculated sample size which is 37 participants.The MBSR group received an 8-week online MBSR program, while the other group received the same program at only the end of the study as a means of gratitude for their participation. The wait-list group were involved in the study to overcome the maturation effect and to maintain the internal validity of the study, ensuring that any improvement in the study outcomes can be attributed to the intervention. Participants were advised not to tell others about the group to which they were allocated and not to share the program contents with others.The intervention was an 8-week self-paced online MBSR program with 2.5 hours of sessions per week through audiovisual materials. The following section will discuss the intervention in detail. In session one, the trainees are introduced to theory and evidence behind mindfulness, the difference between formal and informal exercises, learning proper posture for exercises, mindful eating, mindful breathing, and body scan. In session two, the trainees start exploring their perception about life events, expanding their awareness of breathing, extended body scan, sitting meditation, and how to be present in the moment. In session three, the trainees get introduced to yoga and its practices. In session four, the trainee learned the physiology of stress. In session five, the trainees learned about mindful response and how to apply mindfulness in critical situations. Session six discussed resilience and returning to baseline after experiencing stressful events and revisiting formal and informal exercises. In session seven, the trainees learned how to acquire a broader sense of awareness, being unjudgmental and strengthen daily practices. In session eight, the trainees learned about loving-kindness and strategies to maintain and deepen skills developed throughout the program.