StressMBPPNCT05653375
The Effects of Mindfulness-based Psychoeducation Program on Young People
A study testing Mindfulness-based psychoeducation program and ongoing life in people with Stress and Emotional Intelligence, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The fact that young people starting university during the pandemic period continue this academic period with distance education increases the stress they experience. Therefore, the purpose of this study is to determine the effect of mindfulness-based psychoeducation program applied with distance education on… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional Intelligence, Nursing
- What is being tested?
- Mindfulness-based psychoeducation program and ongoing life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 30 Sep 2021
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years old,
- Without a psychiatric diagnosis,
- Have not done awareness practices before,
- Not meditating,
- Not a foreign national,
- Those who score moderately and above on the Perceived Stress Scale
- Those who volunteered to participate in the study
Who cannot join
- Those who scored less than 25 on the perceived stress scale.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of A Mindfulness-Based Psychoeducation Program Applied With Distance Education on the Psychological Well-Being, Emotional Intelligence and Stress Levels of Youth: A Randomized Controlled Study
Purpose: The fact that young people starting university during the pandemic period continue this academic period with distance education increases the stress they experience. Therefore, the purpose of this study is to determine the effect of mindfulness-based psychoeducation program applied with distance education on the psychological well-being, emotional intelligence, and stress levels of youth.
Method: This study was conducted in a randomized controlled manner with a pretest-posttest control group random design model. The population of the study consisted of 120 newly enrolled students in the nursing department of a foundation university, and the sample consisted of a total of 59 students who met the inclusion criteria of the study. In the sample, while 29 students formed the intervention group, 30 students formed the control group. Mindfulness-Based Psychoeducation Program (MBPP) was applied to the intervention group twice a week for 4 weeks. Perceived Stress Scale (PSS-14), Psychological Well-Being Scale (PWB), and Revised Schutte Emotional Intelligence Scale (SEIS) were used as measurement tools. Further, t-test, Mann Whitney U analysis, and Wilcoxon signed-row test were used in the analysis of the data.
Read the detailed description
Population-Sample: The population of this study consisted of 1st grade students registered at Maltepe University School of Nursing in the 2020-2021 academic year. 64 students who met the criteria for participating in the study (over 18 years of age, without a psychiatric diagnosis, who did not practice mindfulness before, who did not meditate, whose mother tongue was Turkish, who scored above the cut-off point (25˂) in the perceived stress scale) and declared their willingness to be a voluntary participant formed the sample. G*Power 3.1.9.2 program was used to estimate the number of samples (Faul, Erdfelder, Lang et al. (2007). In order to calculate the effect size in power analysis, the relevant literature was examined and the study by Yılmaz (2021) was taken as a basis. The effect size value (Cohen's d) calculated with the emotional intelligence score averages and standard deviations (intervention group= 92.73 ± 13.01; control group = 81.80 ± 8.95) of the intervention and control groups presented in Yılmaz's (2021) study was calculated as .98. In this study, it was determined that, for the one-tailed hypothesis, the minimum number of samples to be included in the study with an effect size of .98, a margin of error of 0.05, and a power of 0.95 should be 48 people in total, 24 for each group (intervention group = 24; control group = 24). Participants were numbered from 1 to 64, and 32 intervention and 32 control groups were created from the www.random.org site, taking into account the possibility of data loss. During the application process, 2 people from the intervention group did not want to continue after the first session, 1 person had long-term internet connection problems, and 2 people from the control group did not fill out the second measurement forms (drop out). The study was completed as 29 intervention and 30 control groups.
Data collection and program application:
Before starting the research, the ethics committee decision dated 08/01/2021 and numbered 2021/01-11 was taken from X Ethics Committee. Data were collected online via google forms. On the first day of the application, other scales except the Perceived Stress Scale were applied simultaneously to the intervention and control groups. The intervention group was given a program for 4 weeks, with 2 sessions per week and each session 90 minutes. At the end of the program, data collection tools were applied to both groups simultaneously again. During this period, no application was made to the control group.
- Conditions
- Stress, Emotional Intelligence, Nursing, Psychological Well-being, Mindfulness
- Being tested
- Mindfulness-based psychoeducation program, ongoing life
- Keywords
- Minfulness, stress, emotional intelligence, psychological well-being, nursing
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based psychoeducation programOther
In this study, a mindfulness-based psychoeducation program was applied to the experimental group, 2 times a week for 4 weeks, with a total of 8 sessions, including methods such as meditation, body scanning, mindful eating, and breathing work. Measurement tools were applied to the experimental and control groups before and after the program.
ongoing lifeOther
The control group continued with their lives without any intervention. Only pre-test and post-test were applied. While the program was applied to the experimental group, no intervention was made to the control group.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based psychoeducation program | Experimental | The group in which the mindfulness-based psychoeducation program was applied. Receives: Other: Mindfulness-based psychoeducation program |
| control group | Active comparator | The group in which no intervention was made and only the pre-test and post-test were applied for comparison. Receives: Other: ongoing life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of psychological well-being after 4 weeks.
Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1 and 7, as strongly disagree (1) to strongly agree (7). Scores range from 8 to 56. A high score indicates that the person has many psychological resources and strengths.
Measured: baseline and 4 weeks.
Change of emotional intelligence level after 4 weeks.
Revised Schutte Emotional Intelligence Scale: The scale, which was studied using the total score, has three sub-dimensions and consists of 41 items. It is a Likert-type scale with items scored between 1 and 5 (1: Never, 5: Always). If the total score of the scale is high, it means that the level of emotional intelligence is also high.
Measured: baseline and 4 weeks.
Change of perceived stress level after 4 weeks.
Perceived Stress Scale: Consisting of 14 items in total, PSS-14 is designed to measure how stressful situations in a person's life are perceived. The scores of the PSS-14 vary between 0 and 56, and the high score indicates a high perception of stress (cut-off point > 25).
Measured: baseline and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Jan 2021
- Primary completion1 Feb 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay Öztürk, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653375
- Sponsor's protocol ID
- 2021/01-11
- Acronym
- MBPP
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk S. The effect of a distance-delivered mindfulness-based psychoeducation program on the psychological well-being, emotional intelligence and stress levels of nursing students in Turkey: a randomized controlled study. Health Educ Res. 2023 Dec 11;38(6):575-586. doi: 10.1093/her/cyad040.
PubMed 37885327
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of A Mindfulness-Based Psychoeducation Program Applied With Distance Education on the Psychological Well-Being, Emotional Intelligence and Stress Levels of Youth: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05653375
- Acronym / sponsor ID
- MBPP / 2021/01-11
- Conditions
- Stress, Emotional Intelligence, Nursing, Psychological Well-being, Mindfulness
- Keywords
- Minfulness, stress, emotional intelligence, psychological well-being, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Dec 2022 (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.
Purpose: The fact that young people starting university during the pandemic period continue this academic period with distance education increases the stress they experience. Therefore, the purpose of this study is to determine the effect of mindfulness-based psychoeducation program applied with distance education on the psychological well-being, emotional intelligence, and stress levels of youth.
Method: This study was conducted in a randomized controlled manner with a pretest-posttest control group random design model. The population of the study consisted of 120 newly enrolled students in the nursing department of a foundation university, and the sample consisted of a total of 59 students who met the inclusion criteria of the study. In the sample, while 29 students formed the intervention group, 30 students formed the control group. Mindfulness-Based Psychoeducation Program (MBPP) was applied to the intervention group twice a week for 4 weeks. Perceived Stress Scale (PSS-14), Psychological Well-Being Scale (PWB), and Revised Schutte Emotional Intelligence Scale (SEIS) were used as measurement tools. Further, t-test, Mann Whitney U analysis, and Wilcoxon signed-row test were used in the analysis of the data.
Detailed description
Population-Sample: The population of this study consisted of 1st grade students registered at Maltepe University School of Nursing in the 2020-2021 academic year. 64 students who met the criteria for participating in the study (over 18 years of age, without a psychiatric diagnosis, who did not practice mindfulness before, who did not meditate, whose mother tongue was Turkish, who scored above the cut-off point (25˂) in the perceived stress scale) and declared their willingness to be a voluntary participant formed the sample. G*Power 3.1.9.2 program was used to estimate the number of samples (Faul, Erdfelder, Lang et al. (2007). In order to calculate the effect size in power analysis, the relevant literature was examined and the study by Yılmaz (2021) was taken as a basis. The effect size value (Cohen's d) calculated with the emotional intelligence score averages and standard deviations (intervention group= 92.73 ± 13.01; control group = 81.80 ± 8.95) of the intervention and control groups presented in Yılmaz's (2021) study was calculated as .98. In this study, it was determined that, for the one-tailed hypothesis, the minimum number of samples to be included in the study with an effect size of .98, a margin of error of 0.05, and a power of 0.95 should be 48 people in total, 24 for each group (intervention group = 24; control group = 24). Participants were numbered from 1 to 64, and 32 intervention and 32 control groups were created from the www.random.org site, taking into account the possibility of data loss. During the application process, 2 people from the intervention group did not want to continue after the first session, 1 person had long-term internet connection problems, and 2 people from the control group did not fill out the second measurement forms (drop out). The study was completed as 29 intervention and 30 control groups.
Data collection and program application:
Before starting the research, the ethics committee decision dated 08/01/2021 and numbered 2021/01-11 was taken from X Ethics Committee. Data were collected online via google forms. On the first day of the application, other scales except the Perceived Stress Scale were applied simultaneously to the intervention and control groups. The intervention group was given a program for 4 weeks, with 2 sessions per week and each session 90 minutes. At the end of the program, data collection tools were applied to both groups simultaneously again. During this period, no application was made to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based psychoeducation program | Experimental | Other: Mindfulness-based psychoeducation programThe group in which the mindfulness-based psychoeducation program was applied. |
| control group | Active comparator | Other: ongoing lifeThe group in which no intervention was made and only the pre-test and post-test were applied for comparison. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Over 18 years old,
- Without a psychiatric diagnosis,
- Have not done awareness practices before,
- Not meditating,
- Not a foreign national,
Key exclusion criteria (1 listed)
- Those who scored less than 25 on the perceived stress scale.
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 |
|---|---|---|
| Mindfulness-based psychoeducation programIn this study, a mindfulness-based psychoeducation program was applied to the experimental group, 2 times a week for 4 weeks, with a total of 8 sessions, including methods such as meditation, body scanning, mindful eating, and breathing work. Measurement tools were applied to the experimental and control groups before and after the program. | Other | mindfulness-based psychoeducation program |
| ongoing lifeThe control group continued with their lives without any intervention. Only pre-test and post-test were applied. While the program was applied to the experimental group, no intervention was made to the control group. | Other | control group |
Primary outcome
Change of psychological well-being after 4 weeks.
Time frame: baseline and 4 weeks.
Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1 and 7, as strongly disagree (1) to strongly agree (7). Scores range from 8 to 56. A high score indicates that the person has many psychological resources and strengths.
Change of emotional intelligence level after 4 weeks.
Time frame: baseline and 4 weeks.
Revised Schutte Emotional Intelligence Scale: The scale, which was studied using the total score, has three sub-dimensions and consists of 41 items. It is a Likert-type scale with items scored between 1 and 5 (1: Never, 5: Always). If the total score of the scale is high, it means that the level of emotional intelligence is also high.
Change of perceived stress level after 4 weeks.
Time frame: baseline and 4 weeks.
Perceived Stress Scale: Consisting of 14 items in total, PSS-14 is designed to measure how stressful situations in a person's life are perceived. The scores of the PSS-14 vary between 0 and 56, and the high score indicates a high perception of stress (cut-off point > 25).
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 16 Dec 2022.
- Derived from this study: PubMed 37885327Ozturk S. The effect of a distance-delivered mindfulness-based psychoeducation program on the psychological well-being, emotional intelligence and stress levels of nursing students in Turkey: a randomized controlled study. Health Educ Res. 2023 Dec 11;38(6):575-586. doi: 10.1093/her/cyad040.
- Individual participant dataSharing planned: No
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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 Mindfulness-based psychoeducation program and ongoing life in people with Stress and Emotional Intelligence, run by Maltepe University at 1 site in Turkey (Türkiye).
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 7 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 16 Dec 2022. 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 Turkey (Türkiye). 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?
Change of psychological well-being after 4 weeks. (time frame: baseline and 4 weeks.). The study lists 3 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 NCT05653375, which also lists 1 linked publication.
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 16 Dec 2022.