NCT06760962

Brief Summary

This study assessed the impact of a six-week Reflective Mindfulness and Emotional Regulation Training (RMERT) program on fourth-year nursing students. Using a randomized controlled trial with 40 participants, the intervention group (n=20) received RMERT, while the control group (n=20) continued standard coursework.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 23, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

Mindfulnessemotional regulationnursing studentsnursing educationself-awarenessmixed method

Outcome Measures

Primary Outcomes (2)

  • Emotion Regulation Questionnaire

    Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores in each subscale. The higher the score, the greater the use of that strategy and vice-versa.

    6 weeks

  • The Mindful Attention Awareness Scale (MAAS)

    The Mindful Attention Awareness Scale (MAAS), developed by Brown and Ryan in 2003, is a 15-item self-report instrument designed to measure a fundamental aspect of mindfulness: a receptive and attentive state of awareness focused on the present moment. Respondents rate their experiences using a six-point Likert scale, ranging from 1 ("almost always") to 6 ("rarely"). The MAAS has demonstrated strong psychometric properties and has been validated across diverse populations, including college students, community members, and individuals with cancer. The overall score is calculated as the average of the 15 items, with higher scores reflecting greater mindfulness.

    6 weeks

Study Arms (2)

study group

EXPERIMENTAL
Behavioral: Reflective Mindfulness and Emotional Regulation training

control group

NO INTERVENTION

no intervention

Interventions

The RMERT program consisted of six weekly 90-minute sessions facilitated by researchers trained in cognitive behavioral therapy (CBT) and transactional analysis (TA). The training employed the ABC model of CBT (Activating events, Beliefs, and Consequences) to address maladaptive cognitive patterns, along with TA techniques such as empathic inquiry and reflection. Relaxation strategies, including diaphragmatic breathing and progressive muscle relaxation, were also integrated. The sessions focused on enabling students to reflect on their mental and emotional states, process their feelings, and apply cognitive reappraisal-a healthy emotional regulation strategy-instead of relying on expressive suppression, which is maladaptive.

study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students enroled in the psychiatric/mental health nursing course for the first time, i.e., did not enrol in or join similar or the same course before.
  • for example, joined the faculty from the secondary school, not through other paths or bridging educational programs that would include psychiatric/mental health courses/modules as part of their programs
  • did not fail the course before or attended it for more time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of nursing Alexandria university

Alexandria, None Selected, 21523, Egypt

Location

Related Publications (3)

  • Veigh CM, Reid J, Carswell C, Ace L, Walsh I, Graham-Wisener L, Rej S, Potes A, Atkinson K, Edginton T, Noble H. Mindfulness as a well-being initiative for future nurses: a survey with undergraduate nursing students. BMC Nurs. 2021 Dec 20;20(1):253. doi: 10.1186/s12912-021-00783-0.

    PMID: 34930234BACKGROUND
  • McVeigh C, Ace L, Ski CF, Carswell C, Burton S, Rej S, Noble H. Mindfulness-Based Interventions for Undergraduate Nursing Students in a University Setting: A Narrative Review. Healthcare (Basel). 2021 Nov 2;9(11):1493. doi: 10.3390/healthcare9111493.

    PMID: 34828538BACKGROUND
  • Salem GMM, Hashimi W, El-Ashry AM. Reflective mindfulness and emotional regulation training to enhance nursing students' self-awareness, understanding, and regulation: a mixed method randomized controlled trial. BMC Nurs. 2025 Apr 30;24(1):478. doi: 10.1186/s12912-025-03086-w.

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Forty students met the eligibility requirements and were randomly assigned at a 1:1 ratio to control and intervention groups of twenty each. The intervention set was then split into ten subgroups to form counseling groups. The intervention and control groups completed the pre-test and post-tests one week before the sessions began and one week after they ended. Students' identifiers were removed to ensure confidentiality. In two subgroups of 10, each intervention group attended intervention sessions, while the control group did not receive any intervention sessions. During the intervention sessions, both groups attended the theoretical and clinical parts of the psychiatric mental health nursing course with their colleagues. As part of their training, they facilitated nursing services for actual patients in clinical settings.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The RMERT program consisted of six weekly 90-minute sessions facilitated by researchers trained in cognitive behavioral therapy (CBT) and transactional analysis (TA). The training employed the ABC model of CBT (Activating events, Beliefs, and Consequences) to address maladaptive cognitive patterns, along with TA techniques such as empathic inquiry and reflection. Relaxation strategies, including diaphragmatic breathing and progressive muscle relaxation, were also integrated. The sessions focused on enabling students to reflect on their mental and emotional states, process their feelings, and apply cognitive reappraisal-a healthy emotional regulation strategy-instead of relying on expressive suppression, which is maladaptive.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 7, 2025

Study Start

January 1, 2023

Primary Completion

January 20, 2024

Study Completion

April 20, 2024

Last Updated

January 7, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

The study authors indicated that individual participant data (IPD), including the following, will be shared upon reasonable request: De-identified Data: Pre- and post-intervention scores from the Emotion Regulation Questionnaire (ERQ) and the Mindful Attention Awareness Scale (MAAS). Demographic and baseline data (e.g., age, gender, residence, GPA, marital status, and employment status) in de-identified format. Qualitative Data: De-identified transcriptions of intervention group sessions used for thematic analysis. Study Protocol and Analysis Plans: The detailed intervention framework, including the six-session RMERT program outline. Quantitative and qualitative data analysis plans. Consent Documentation: Sample forms used to obtain participant consent (in anonymized form). Ethical Approvals: Approval details are provided by the Research Ethics Committee. This data will be made available upon request to the corresponding author, provided the request aligns with ethical considerations.

Shared Documents
STUDY PROTOCOL
Time Frame
2 weeks
Access Criteria
all authors of the study

Locations