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.
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
- Conditions the study is for
- Occupational Stress and Mental Health in Clinical Nurses, Psychological Stress, Emotional Regulation Difficulties
- What is being tested?
- REGULA-T
- Type of treatment
- Lifestyle or therapy programme
- 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.
Spain1 site
Universidad Villanueva
Madrid, Madrid, 28034
Begoña Haro, Doctor, +34917340413, begona.haro@villanueva.edu
bharoescribano@gmail.com
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.
- Conditions
- Occupational Stress and Mental Health in Clinical Nurses, Psychological Stress, Emotional Regulation Difficulties
- 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 group | Role | What they receive |
|---|---|---|
| REGULA-T intervention group | Experimental | Participants in this arm receive the REGULA-T program during their clinical placements. Receives: Behavioral: REGULA-T |
| Waitlist control group | No intervention | Standard 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.
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
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
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
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
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)
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
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.
- First posted30 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Stress and Mental Health in Clinical NursesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad Villanueva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begona Haro, Universidad Villanueva
- Investigators
- Begoña Haro, Doctor, Principal investigator, Universidad VillanuevaBelén Aguilar, Study director, Universidad Villanueva
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Regulation and Stress Coping in Nursing Students During Clinical Placements (REGULA-T): Protocol for a Mixed-Methods Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07735832
- Acronym / sponsor ID
- REGULA-T / REGULA-T
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad VillanuevaUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGULA-T intervention group | Experimental | Behavioral: REGULA-TParticipants in this arm receive the REGULA-T program during their clinical placements. |
| Waitlist control group | No intervention | –Standard curricular follow-up; access to the program after the posttest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Informed consent
Key exclusion criteria (2 listed)
- Language difficulties precluding correct comprehension of the instruments
- Diagnosis of a severe mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGULA-TGroup-based Emotional Management Workshop (9 sessions, two modules; large-group sessions ≈17 participants, small-group sessions ≈8) plus on-demand Individual Support Service (SAI) | Behavioural | REGULA-T intervention group |
Primary outcome
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)
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).
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).
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).
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).
2 secondary outcomes
Treatment satisfaction
Time frame: At the end of the intervention, 9 months from enrollment
Participants' and tutors' experiences (focus groups)
Time frame: After completion of the intervention, up to 10 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Begoña Haro, Doctor principal investigator
Universidad Villanueva
Belén Aguilar study director
Universidad Villanueva
1 site in 1 country: see every site and its status.
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.