Undergraduate Health Professional StudentsNCT06760962
Reflective Mindfulness and Emotional Regulation Training to Enhance Nursing Students' Self-Awareness, Understanding, and Regulation
A study testing Reflective Mindfulness and Emotional Regulation training in people with Undergraduate Health Professional Students, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Undergraduate Health Professional Students
- What is being tested?
- Reflective Mindfulness and Emotional Regulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of nursing Alexandria university
Alexandria, None Selected, 21523
About this study
Official title: Reflective Mindfulness and Emotional Regulation Training to Enhance Nursing Students' Self-Awareness, Understanding, and Regulation: A Mixed Method Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Reflective Mindfulness and Emotional Regulation training
- Keywords
- Mindfulness, emotional regulation, nursing students, nursing education, self-awareness, mixed method
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflective Mindfulness and Emotional Regulation trainingBehavioural
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 | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Behavioral: Reflective Mindfulness and Emotional Regulation training |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2023
- Primary completion20 Jan 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Undergraduate Health Professional StudentsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Ayman Mohamed El-Ashry, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760962
- Sponsor's protocol ID
- Nursing college, Benha Univ
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34930234McVeigh 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.
PubMed 34828538Salem 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.
PubMed 40307764
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflective Mindfulness and Emotional Regulation Training to Enhance Nursing Students' Self-Awareness, Understanding, and Regulation: A Mixed Method Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06760962
- Acronym / sponsor ID
- Nursing college, Benha Univ
- Keywords
- Mindfulness, emotional regulation, nursing students, nursing education, self-awareness, mixed method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 7 Jan 2025 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: Reflective Mindfulness and Emotional Regulation training |
| control group | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Reflective Mindfulness and Emotional Regulation trainingThe 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. | Behavioural | study group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Results publication: PubMed 34930234Veigh 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.
- Results publication: PubMed 34828538McVeigh 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.
- Derived from this study: PubMed 40307764Salem 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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflective Mindfulness and Emotional Regulation training in people with Undergraduate Health Professional Students, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Questionnaire (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06760962, which also lists 3 linked publications.
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 7 Jan 2025.