Emotional Regulation and Stress Coping Program for Nursing Students During Clinical Placements

Overview

The goal of this clinical trial is to learn whether REGULA-T, a group-based emotional-skills program, improves stress coping and emotion regulation in nursing students during their clinical placements. The program is aimed at nursing students aged 18 or older enrolled in supervised clinical placements. The main questions it aims to answer are: Does it reduce their difficulties in regulating emotions and improve their perceived emotional intelligence and coping strategies? Does the program reduce perceived stress and anxiety in students during their placements? Researchers will compare students who take part in the REGULA-T program with students who follow the standard curriculum (waiting-list control group, who are offered the program after the study) to see whether the program improves emotional wellbeing during clinical placements. Participants in the program will: * Attend a 9-session emotional-management workshop held in two modules across the academic year, timed to coincide with their clinical placements * Have access to an on-demand individual support service throughout the year * Complete online questionnaires before their placements begin and again after they finish * Optionally take part, after the final questionnaires, in an online group discussion about their experience Participants in the control group will follow their standard curriculum, complete the same online questionnaires at the same two time points, and be offered the program once the study is complete.

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. Analysis. Quantitative analyses (IBM SPSS Statistics v24) will follow an intention-to-treat approach, keeping participants in their original allocation group regardless of SAI use. Effect estimates will be obtained through complementary between-group (post-test) and within-group (pre-post) comparisons, reporting effect sizes with 95% confidence intervals. SAI use will be recorded for the whole sample and treated as a co-intervention in pre-specified sensitivity analyses; a per-protocol analysis restricted to adherent participants will also be conducted. Quantitative and qualitative findings will be integrated through triangulation during interpretation.