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

NCT07735832 | Not Yet Recruiting

• 3 other identifiers: REGULA-TPPP26-00022026-41
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Occupational Stress and Mental Health in Clinical Nurses; Psychological Stress; Emotional Regulation Difficulties

Keywords

nursing students; clinical placement; emotion regulation; stress coping; psychoeducational intervention

Outcome Measures

Primary Outcomes (5)

• 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)

  From enrollment to the end of the intervention at 9 months

• 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).

  From enrollment to the end of the intervention at 9 months

• 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).

  From enrollment to the end of the intervention at 9 months

• 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).

  From enrollment to the end of the intervention at 9 months

• State-trait anxiety (STAI)

  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).

  From enrollment to the end of the intervention at 9 months

Secondary Outcomes (2)

• Treatment satisfaction

  At the end of the intervention, 9 months from enrollment

• Participants' and tutors' experiences (focus groups)

  After completion of the intervention, up to 10 months from enrollment

Study Arms (2)

REGULA-T intervention group

EXPERIMENTAL

Participants in this arm receive the REGULA-T program during their clinical placements.

Behavioral: REGULA-T

Waitlist control group

NO INTERVENTION

Standard curricular follow-up; access to the program after the posttest.

Interventions

REGULA-T BEHAVIORAL

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)

REGULA-T intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Language difficulties precluding correct comprehension of the instruments
• Diagnosis of a severe mental disorder

Sponsors & Collaborators

• Universidad Villanueva: lead

Study Sites (1)

Universidad Villanueva

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Occupational Stress; Stress, Psychological; Emotional Regulation

Condition Hierarchy (Ancestors)

Occupational Diseases; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Begoña Haro, Doctor

  Universidad Villanueva

  PRINCIPAL INVESTIGATOR

• Belén Aguilar

  Universidad Villanueva

  STUDY DIRECTOR

Central Study Contacts

Begona Haro, PhD

CONTACT

+34917340413; begona.haro@unavarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 30, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

ES (1)