About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥18
Enrolled in Clinical Placements I or II of the Nursing Degree at Universidad Villanueva
Signed informed consent (intervention group also signs an attendance commitment
Registered nurses currently or previously supervising nursing students
Disqualifiers
Language difficulties precluding correct comprehension of the instruments
Diagnosis of a severe mental disorder
Trial design
Parallel
Treatments tested in this trial
REGULA-T
BehavioralGroup-based Emotional Management Workshop (9 sessions, two modules; large-group sessions ≈17 participants, small-group sessions ≈8) plus on-demand Individual Support Service (SAI)
Treatment groups
Trial outcomes
Primary outcomes
Perceived stress (PSS-10)
Perceived stress over the past month, measured by the 10-item Perceived Stress Scale (score range 0-40; higher scores indicate greater perceived stress)
Coping strategies (CRI-A)
Coping Responses Inventory-Adult Form. The inventory comprises 48 items rated on a 4-point scale, grouped into eight subscales (each scored from 0 to 18) that form two dimensions: Approach Coping and Avoidance Coping. Higher scores on approach coping subscales indicate greater use of adaptive coping strategies (better outcome); higher scores on avoidance coping subscales indicate greater use of avoidant strategies (worse outcome).
Perceived emotional intelligence (TMMS-24)
Trait Meta-Mood Scale-24. The scale comprises 24 items rated on a 5-point Likert scale across three subscales (Attention, Clarity, and Repair), each scored from 8 to 40. Higher scores indicate greater perceived emotional intelligence (better outcome).
Emotion regulation difficulties (DERS)
Difficulties in Emotion Regulation Scale. The Spanish version comprises 28 items rated on a 5-point Likert scale, with total scores ranging from 28 to 140. Higher scores indicate greater difficulties in emotion regulation (worse outcome).
Secondary outcomes
Treatment satisfaction
Participant satisfaction with the program, measured by a Treatment Satisfaction Questionnaire (higher scores indicate greater satisfaction).
Participants' and tutors' experiences (focus groups)
Qualitative exploration of emotional competence, stress-coping strategies, and support needs through three online focus groups (intervention students, control students, clinical tutors), analysed by thematic analysis.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: