Determining the influence of a sleep improvement intervention on medical students' sleep and fatigue: protocol of the PROMESS-Sleep clinical trial

Abstract

Background: Medical students face a demanding workload, stressful situations, and irregular sleep patterns, which can lead to elevated sleep disturbances and high fatigue levels. These difficulties may be further associated with a major decline in well-being, quality of life, performance, and health. Thus, these struggles must be addressed to reduce these students' sleep disturbances and fatigue during their curriculum.

Methods: The PROMESS-Sleep clinical trial aims to support future healthcare professionals by enhancing their abilities to manage their sleep. The support will be provided through a three-session sleep management program. Each session will include an individual meeting between a PROMESS-Sleep expert and a medical student, during which self-care education, advice, and personalized goals will be established. The present protocol is designed to assess the influence of this program on 45 undergraduate medical students (fourth- and fifth-year) of the Lyon-Est Faculty of Medicine (Claude Bernard University Lyon 1, France). Assessments of sleep and fatigue will be conducted before and during the intervention using self-reported questionnaires and actigraphy. At the end of the third session, the student's satisfaction levels regarding the program will be assessed. The primary outcome will be changes in scores on the Pittsburgh Sleep Quality Index (PSQI) during the program. Secondary outcomes will provide a detailed characterization of changes in various aspects of sleep disturbances, fatigue, sleep habits, and sleep-wake rhythms. Exploratory outcomes will provide information regarding the students' satisfaction levels and will determine the moderators of the program's efficacy. Data will be analyzed according to the intention-to-treat principle and presented in accordance with the CONSORT Guidelines. Ethical approval has been obtained by the Institutional Review Board (IRB: 2023-07-04-03), and all procedures will be performed in adherence to the Helsinki Declaration. The results from this study will be presented at scientific conferences and in peer-reviewed scientific journals.

Discussion: The results will provide valuable insights into the program's efficacy in reducing sleep disturbances and fatigue. If its efficacy is proven, PROMESS-Sleep could become an integral and sustainable part of medical education due to fostering a healthier and more resilient future for healthcare professionals. This manuscript follows the SPIRIT guidelines (Additional files 1 & 8).

Trial registration: ClinicalTrials.gov: NCT06297330; retrospectively registered.

Keywords: Actigraphy; Curriculum; Disturbance; Fatigue; Health intervention; PSQI; Pedagogy; Peer coaching; Physiology; Prevention; Remediation; Sleep.

Fig. 1

Study Design. Seventy undergraduate medical students will be enrolled. First, students will perform baseline measurements. Then, they will be randomized into a control or an interventional group stratified by gender and study years (fourth or fifth). This clinical trial (PROMESS-Sleep) will specifically focus on the interventional group (n = 45). Each student in this group will be simply randomly assigned to one of the three periods to follow a sleep improvement program (i.e., PROMESS-Sleep). This program will consist of three sessions spaced 14 to 21 days apart. The primary outcome will be the PSQI scores during sessions 1, 2, and 3. Secondary outcomes will comprise VAS scores, MFI scores, and sleep variables assessed through a survey and/or actigraphy. Exploratory outcomes will include the student’s level of satisfaction regarding the program and will determine the moderators of the program’s efficacy. Abbreviations: CSM, Composite Scale of Morningness; ESS, Epworth Sleepiness Scale; MFI, Multidimensional Fatigue Inventory; PSQI, Pittsburgh Sleep Quality Index; VAS, Visual Analog Scale

Fig. 2

Sleep-wake rhythms variables

Fig. 3

The PROMESS-Sleep program. Before the intervention, the levels of sleep disturbances and fatigue, sleep habits, and sleep-wake rhythms of the students will be assessed through questionnaires and actigraphy to establish baseline scores. The PROMESS-Sleep program will comprise three sessions spaced 14 to 21 days apart. Each session will involve an individual meeting between a PROMESS-Sleep expert and a student. These sessions aim to identify students’ needs regarding sleep and fatigue, set individual goals, and reduce sleep trouble and fatigue. Between each session, students will wear accelerometers and fill out online sleep diaries to determine sleep-wake rhythms. Abbreviations: CSM, Composite Scale of Morningness; ESS, Epworth Sleepiness Scale; MFI, Multidimensional Fatigue Inventory; PSQI, Pittsburgh Sleep Quality Index; S1, Session 1; S2, Session 2

Fig. 4

Example of the pedagogical content of the PROMESS-Sleep program. During the sessions, students will receive pedagogical content on sleep and sleep hygiene and individual feedback related to their sleep and fatigue. This figure illustrates an example of the PROMESS-Sleep support given during session 1. A 3-part sleep-cycle will be provided: the “day” part with scores of daytime sleepiness and fatigue encountered at baseline; the “evening” part; and the “night” part with sleep disturbances levels, sleep habits, and chronotype. Providing quantified information will allow the experts and the students to discuss these scores and identify the students’ needs. Abbreviations: CSM, Composite Scale of Morningness; ESS, Epworth Sleepiness Scale; MFI, Multidimensional Fatigue Inventory; PSQI, Pittsburgh Sleep Quality Index