Emotional Regulation and Stress Coping in Nursing Students During Clinical Placements (REGULA-T): Protocol for a Mixed-Methods Quasi-Experimental Study

Design and reporting standards. This is a mixed-methods study with an embedded design, comprising a prospective quasi-experimental quantitative component with two non-equivalent groups and pre-test/post-test measures, and a qualitative component. The quantitative component is reported in accordance with the TREND statement and the intervention is described following the TIDieR checklist; the qualitative component follows the COREQ criteria.

Group assignment and control of selection bias. Assignment to groups is non-random and determined by each student's voluntary decision to enrol in the program, reflecting ethical and practical constraints of the educational setting. Because initial equivalence between groups cannot be guaranteed, the design incorporates a pre-test in both groups, examines baseline comparability, and adjusts the effect estimates for pre-test scores; residual selection bias is acknowledged as a limitation.

Intervention structure. The Emotional Management Workshop is delivered face-to-face across nine sessions organised in two modules synchronised with the two placement periods. Each module alternates large-group sessions (delivered before the rotation, psychoeducational in nature) with small-group sessions (delivered during the rotation, experiential in nature). Module 1 introduces cognitive restructuring and emotion-regulation strategies; Module 2 incorporates breathing techniques for physiological deactivation and the scheduling of alternative rewarding activities; the final session provides synthesis and closure. Each session follows a common structure: review of previously assigned tasks, delivery and practice of the corresponding contents and techniques, and prescription of inter-session tasks, adapted in the first and last sessions. The workshop is complemented by an on-demand Individual Support Service (SAI) that reinforces workshop skills, allows individual recovery of large-group contents missed through justified absence, and addresses specific emotional difficulties. During the study, control-group participants may access the SAI only for emotional containment, risk assessment and referral, without delivery of program contents, preserving the integrity of the comparison condition.

Facilitator training and treatment fidelity. The workshop and the SAI are delivered by psychologists with prior training and experience in emotion-regulation and stress-management workshops, who receive standardised theoretical training on the intervention manual before implementation. Fidelity is monitored through a per-session fidelity checklist-each session being considered fidelity-adherent when at least 80% of the planned contents are covered, with deviations recorded and pending contents recovered in the following session-and through fortnightly coordination meetings with the principal investigator, with an additional meeting at the close of each module.

Qualitative component. After the post-test, three online focus groups (intervention students, control students, and clinical tutors) will be conducted by a moderator not involved in delivering the intervention, using a profile-specific semi-structured topic guide. Sessions will be recorded and transcribed verbatim and analysed through reflexive inductive thematic analysis, with independent coding by two researchers and resolution of discrepancies by consensus.