Resilience-based Intervention, Emotional Regulation, Grit and Life SatisfactionNCT05828316
The Impact of a Resilience-based Intervention on Emotional Regulation, Grit and Life Satisfaction: A Comparative Study Between Egyptian and Saudi Nursing Students
A study testing Resilience-based intervention in people with Resilience-based Intervention, Emotional Regulation, Grit and Life Satisfaction, run by Alexandria University at 1 site in Egypt.
Trial summary
Nursing students may be perceived as having a stable college experience because they have a relatively clear career goal and a higher employment rate than students in other majors, but they consistently report that their heavy study loads, frequent exams, and clinical practice cause them to feel more stressed and… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Resilience-based Intervention, Emotional Regulation, Grit and Life Satisfaction
- What is being tested?
- Resilience-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2023to 5 Aug 2023
- 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 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- nursing students who are willing to participate in the study and don't have any psychiatric illnesses
Who cannot join
- Those who refuse to participate in the study, nursing students with psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing
Alexandria
Eman Taha, professor, 01283440749, eman.taha@alexu.edu.eg
About this study
Nursing students may be perceived as having a stable college experience because they have a relatively clear career goal and a higher employment rate than students in other majors, but they consistently report that their heavy study loads, frequent exams, and clinical practice cause them to feel more stressed and depressed than students in other majors (Chernomas \& Shapiro 2013, Lee \& Jang 2021). Focusing on emotional events that have a direct impact on nursing students' learning and the college experience is crucial to their psychological wellbeing (Lee \& Jang 2021). In order to improve the emotional experiences and life satisfaction of nursing students, it is crucial to determine the factors that affect their emotions.
Read the detailed description
A constructivist and grounded theory design was recently used to create a model of resilience for nursing students (Reyes et al. 2015). Three steps represent how resilience is experienced, according to the "Pushing Through" model of resilience: first, "stepping into," or embracing, the adversity. The second is "staying the course," or understanding that they must keep working toward their objectives. Finally, "acknowledge" what they have learned from their difficulties and how they feel prepared to face new challenges. Additionally, students had brief obstacles, such as 'disengaging' from class because they felt overburdened. This paradigm serves as a lens to illustrate how, despite facing challenges, resilience can be developed over time. There is early support for encouraging resilience in nursing students before they begin their professions given the data linking resilience to burnout in nursing students
- Being tested
- Resilience-based intervention
- Medical subject headings
- Emotional Regulation, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-based interventionBehavioural
resilience-based intervention is a curriculum that offers a careful selection of evidence-based exercises to build coping skills and promote thriving. The resilience-based intervention philosophy is that there are many routes to achieving greater resiliency. Each participants choose from a menu of exercises in the areas of goal-setting, emotional skills, social connection, health, meaning, and self-talk. The ability to choose exercises that fit their specific goals, interests, and schedules is important, because the most effective strategies are the ones that people actually do, which tend to be the ones that are most enjoyable and personally relevant. No single practice is going to work for everyone regardless of its proven benefits. resilience-based intervention makes improving well-being accessible, manageable and fun, by introducing a variety of bite-sized, exercises that participants can experiment with and find what works for them.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 60 students (30 nursing students in alexandria- 30 nursing students in Saudi). They will participate in resilience based intervention Receives: Behavioral: Resilience-based intervention |
| Control group | No intervention | 60 students (30 nursing students in alexandria- 30 nursing students in Saudi). They will not participate in resilience based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Emotion Regulation Questionnaire (ERQ)
It is a 10-item self-report scale designed to assess the habitual use of two commonly used strategies to alter emotion: cognitive reappraisal and expressive suppression. Participants respond to each item using a 7-point Likert scale ranging from 1 n(strongly disagree) to 7 (strongly agree). Cognitive reappraisal involves thinking differently about a situation in order to change its meaning in order to alter one's emotional experience. Expressive suppression involves decreasing the outward expression of emotion. Six items contribute to the subscale for cognitive reappraisal (e.g., "When I'm faced with a stressful situation, I make myself think about it in a way that helps me stay calm"). Four items contribute to the subscale for expressive suppression (e.g., "When I am feeling negative emotions, I make sure not to express them") (Gross, \& John 2003).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start2 Jan 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion5 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience-based Intervention, Emotional Regulation, Grit and Life SatisfactionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828316
- Sponsor's protocol ID
- 4112023
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Resilience-based Intervention on Emotional Regulation, Grit and Life Satisfaction: A Comparative Study Between Egyptian and Saudi Nursing Students
- ClinicalTrials.gov ID
- NCT05828316
- Acronym / sponsor ID
- 4112023
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 5 Aug 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
Nursing students may be perceived as having a stable college experience because they have a relatively clear career goal and a higher employment rate than students in other majors, but they consistently report that their heavy study loads, frequent exams, and clinical practice cause them to feel more stressed and depressed than students in other majors (Chernomas \& Shapiro 2013, Lee \& Jang 2021). Focusing on emotional events that have a direct impact on nursing students' learning and the college experience is crucial to their psychological wellbeing (Lee \& Jang 2021). In order to improve the emotional experiences and life satisfaction of nursing students, it is crucial to determine the factors that affect their emotions.
Detailed description
A constructivist and grounded theory design was recently used to create a model of resilience for nursing students (Reyes et al. 2015). Three steps represent how resilience is experienced, according to the "Pushing Through" model of resilience: first, "stepping into," or embracing, the adversity. The second is "staying the course," or understanding that they must keep working toward their objectives. Finally, "acknowledge" what they have learned from their difficulties and how they feel prepared to face new challenges. Additionally, students had brief obstacles, such as 'disengaging' from class because they felt overburdened. This paradigm serves as a lens to illustrate how, despite facing challenges, resilience can be developed over time. There is early support for encouraging resilience in nursing students before they begin their professions given the data linking resilience to burnout in nursing students
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Resilience-based intervention60 students (30 nursing students in alexandria- 30 nursing students in Saudi). They will participate in resilience based intervention |
| Control group | No intervention | –60 students (30 nursing students in alexandria- 30 nursing students in Saudi). They will not participate in resilience based intervention |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- nursing students who are willing to participate in the study and don't have any psychiatric illnesses
Key exclusion criteria (1 listed)
- Those who refuse to participate in the study, nursing students with psychiatric illnesses
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 |
|---|---|---|
| Resilience-based interventionresilience-based intervention is a curriculum that offers a careful selection of evidence-based exercises to build coping skills and promote thriving. The resilience-based intervention philosophy is that there are many routes to achieving greater resiliency. Each participants choose from a menu of exercises in the areas of goal-setting, emotional skills, social connection, health, meaning, and self-talk. The ability to choose exercises that fit their specific goals, interests, and schedules is important, because the most effective strategies are the ones that people actually do, which tend to be the ones that are most enjoyable and personally relevant. No single practice is going to work for everyone regardless of its proven benefits. resilience-based intervention makes improving well-being accessible, manageable and fun, by introducing a variety of bite-sized, exercises that participants can experiment with and find what works for them. | Behavioural | Intervention group |
Primary outcome
The Emotion Regulation Questionnaire (ERQ)
Time frame: 2 weeks
It is a 10-item self-report scale designed to assess the habitual use of two commonly used strategies to alter emotion: cognitive reappraisal and expressive suppression. Participants respond to each item using a 7-point Likert scale ranging from 1 n(strongly disagree) to 7 (strongly agree). Cognitive reappraisal involves thinking differently about a situation in order to change its meaning in order to alter one's emotional experience. Expressive suppression involves decreasing the outward expression of emotion. Six items contribute to the subscale for cognitive reappraisal (e.g., "When I'm faced with a stressful situation, I make myself think about it in a way that helps me stay calm"). Four items contribute to the subscale for expressive suppression (e.g., "When I am feeling negative emotions, I make sure not to express them") (Gross, \& John 2003).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience-based intervention in people with Resilience-based Intervention, Emotional Regulation, Grit and Life Satisfaction, 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 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Khedr, Lecturer (+201206137019 ext. 002, mahmoud.khedr@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Emotion Regulation Questionnaire (ERQ) (time frame: 2 weeks). 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 25 Apr 2023.