Occupational Stress and Mental Health in Clinical NursesPsychological StressEmotional Regulation Difficulties
Investigational drug(s) / intervention(s)
REGULA-T
REGULA-T: Group-based Emotional Management Workshop (9 sessions, two modules; large-group sessions ≈17 participants, small-group sessions ≈8) plus on-demand Individual Support Service (SAI)
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Qualitative - clinical tutors:
* Registered nurses currently or previously supervising nursing students
* Informed consent
Exclusion Criteria:
* Language difficulties precluding correct comprehension of the instruments
* Diagnosis of a severe mental disorder
Primary outcome measure(s)
Perceived stress (PSS-10) — From enrollment to the end of the intervention at 9 months 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) — From enrollment to the end of the intervention at 9 months 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) — From enrollment to the end of the intervention at 9 months 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) — From enrollment to the end of the intervention at 9 months 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).
State-trait anxiety (STAI) — From enrollment to the end of the intervention at 9 months State-Trait Anxiety Inventory. The scale comprises two 20-item subscales (State Anxiety and Trait Anxiety), each scored from 0 to 60. Higher scores indicate greater anxiety (worse outcome).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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