- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760962
Reflective Mindfulness and Emotional Regulation Training to Enhance Nursing Students' Self-Awareness, Understanding, and Regulation
Reflective Mindfulness and Emotional Regulation Training to Enhance Nursing Students' Self-Awareness, Understanding, and Regulation: a Mixed Method Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study evaluated the effectiveness of Reflective Mindfulness and Emotional Regulation Training (RMERT) in enhancing nursing students' self-awareness, emotional understanding, and regulation. Nursing students frequently face significant academic and psychological challenges, particularly in mental health nursing courses, which can lead to stress, anxiety, and compromised well-being. RMERT was designed as a psychoeducational intervention integrating mindfulness and emotional regulation techniques to help students develop critical skills for managing these challenges.
Study Design The randomized controlled trial employed a mixed-methods approach and involved 40 fourth-year undergraduate nursing students at Benha University. Participants were randomly allocated into an intervention group (n=20) and a control group (n=20). The intervention group attended a six-week RMERT program, while the control group continued their standard academic activities without additional interventions. Both groups underwent pre- and post-intervention assessments using validated instruments: the Emotion Regulation Questionnaire (ERQ) and the Mindful Attention Awareness Scale (MAAS). Qualitative data, collected exclusively from the intervention group, were analysed thematically.
Intervention The RMERT program consisted of six weekly 90-minute sessions facilitated by researchers trained in cognitive behavioural 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
None Selected
-
Alexandria, None Selected, Egypt, 21523
- faculty of nursing Alexandria university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
no
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
no intervention
|
|
|
Experimental: study group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion Regulation Questionnaire
Time Frame: 6 weeks
|
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)
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nursing college, Benha Univ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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