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Occupational Stress and Mental Health in Clinical NursesREGULA-TNCT07735832

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

A study testing REGULA-T in people with Occupational Stress and Mental Health in Clinical Nurses and Psychological Stress, run by Universidad Villanueva at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
REGULA-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
15 Sep 2026to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Begona Haro, PhD contact

+34917340413

begona.haro@unavarra.es

Spain1 site
  • Universidad Villanueva

    Madrid, Madrid, 28034

    Begoña Haro, Doctor, +34917340413, begona.haro@villanueva.edu

    bharoescribano@gmail.com

Other trials in Spain

About this study

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

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?

Read more

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.

Read the detailed description

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.

Being tested
REGULA-T
Keywords
nursing students, clinical placement, emotion regulation, stress coping, psychoeducational intervention
Medical subject headings
Occupational Stress, Stress, Psychological, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGULA-TBehavioural

    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 groups in NCT07735832
Study groupRoleWhat they receive
REGULA-T intervention groupExperimentalParticipants in this arm receive the REGULA-T program during their clinical placements.
Receives: Behavioral: REGULA-T
Waitlist control groupNo interventionStandard curricular follow-up; access to the program after the posttest.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: From enrollment to the end of the intervention at 9 months

  2. 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).

    Measured: From enrollment to the end of the intervention at 9 months

  3. 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).

    Measured: From enrollment to the end of the intervention at 9 months

  4. 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).

    Measured: From enrollment to the end of the intervention at 9 months

  5. 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).

    Measured: From enrollment to the end of the intervention at 9 months

Secondary outcomes (2)
  1. Treatment satisfaction

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

    Measured: At the end of the intervention, 9 months from enrollment

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07735832
Sponsor's protocol ID
REGULA-T
Other IDs
PPP26-0002, 2026-41
Acronym
REGULA-T
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
30 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing REGULA-T in people with Occupational Stress and Mental Health in Clinical Nurses and Psychological Stress, run by Universidad Villanueva at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Begona Haro, PhD (+34917340413, begona.haro@unavarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived stress (PSS-10) (time frame: From enrollment to the end of the intervention at 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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