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NCT Number: NCT07735832

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Perceived stress (PSS-10)

    Time frame: 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)

  2. Coping strategies (CRI-A)

    Time frame: 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).

  3. Perceived emotional intelligence (TMMS-24)

    Time frame: 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).

  4. Emotion regulation difficulties (DERS)

    Time frame: 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).

  5. State-trait anxiety (STAI)

    Time frame: 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).

Secondary outcomes

  1. Treatment satisfaction

    Time frame: At the end of the intervention, 9 months from enrollment

    Participant satisfaction with the program, measured by a Treatment Satisfaction Questionnaire (higher scores indicate greater satisfaction).

  2. Participants' and tutors' experiences (focus groups)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Begona Haro, PhD

CONTACT

[email protected]

+34917340413

Sponsors and collaborators

Lead sponsor

Universidad Villanueva

Other

Registry information

Official study title

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

Acronym: REGULA-T

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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