StressMBSRNCT05100537
Effect of Mindfulness Based Stress Reduction (MBSR) Programme for Reducing the Stress Level of Nursing Student
A study testing Mindfulness Based Stress Reduction and continuing a routine life in people with Stress and Emotion Regulation, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This research was planned to determine the effect of mindfulness-based stress reduction program on reducing the stress level and emotion regulation of nursing students. Design: The research was planned as a pretest, posttest, follow-up and randomized controlled study in order to determine the effect of the… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotion Regulation
- What is being tested?
- Mindfulness Based Stress Reduction and continuing a routine life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 27 Jun 2022
- 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
- Age range is 18-25 years old
- Being a student in the second or third year of the nursing department
- Regular attendance at school
- Not having a communication problem related to vision or hearing
- It was determined as having a score of 26 or more from the perceived stress scale.
Who cannot join
- Have a psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness Based Stress Reduction Programme for Reducing the Stress Level and Emotion Regulation of Nursing Students
Purpose: This research was planned to determine the effect of mindfulness-based stress reduction program on reducing the stress level and emotion regulation of nursing students.
Design: The research was planned as a pretest, posttest, follow-up and randomized controlled study in order to determine the effect of the mindfulness-based stress reduction program on the stress level and emotion regulation of nursing students.
Read more
Hypotheses: H1: The perceived stress level scores of nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease compared to the nursing students in the control group.
H2: The perceived stress level of the nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease according to their pretest scores.
H3: Emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the nursing students in the control group.
H4: The posttest and follow-up emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the pretest.
- Conditions
- Stress, Emotion Regulation
- Being tested
- Mindfulness Based Stress Reduction, continuing a routine life
- Keywords
- Mindfulness, Nursing student
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
The intervention has its roots in meditations and yoga practices. However, it is independent of religious purpose or affiliation.The weekly sessions include a range of mental and bodily practices, including awareness of emotions, awareness of thoughts, awareness of sensations. It involves full awareness of daily activities, using the breath as an anchor for attention.In addition to mindfulness practices and experiential work, psychoeducation and participants' sharing will clarify the issues of stress, stress management and how mindfulness is applied in daily situations and interpersonal communication.
continuing a routine lifeOther
No intervention will be made in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | The Mindfulness Based Stress Reduction program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks. Receives: Behavioral: Mindfulness Based Stress Reduction |
| CONTROL GROUP | Active comparator | no intervention Receives: Other: continuing a routine life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The 14-item scale was designed to measure how stressful the individual perceives certain situations in his life. The scale is in 5-point Likert type, ranging from "Never (0)" to "Very often (4)". 7 of the scale items with positive expressions are scored in reverse. The total score from the scale indicates the stress level of the person. A score between 11-26 indicates a low stress level, a score between 27-41 indicates a medium stress level, and a score between 42-56 indicates a high stress level.
Measured: For 3 months
Cognitive Emotion Regulation Scale
It is a five-point Likert type scale (1 = not at all suitable for me, 2 = somewhat suitable for me, 3 = somewhat suitable for me, 4 = very suitable for me, 5 = completely suitable for me). The scale consists of 36 items in total. Cronbach's alpha value in the original form of the scale. with 67. It is between 81. The scale includes "self-blame", "acceptance", "focus on thought", "positive refocus", "plan refocus", "positive reconsideration", "perspective", "destruction" and "blaming others". It consists of nine sub-dimensions.
Measured: For 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Nov 2021
- Primary completion3 May 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Alagoz, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100537
- Sponsor's protocol ID
- 0051
- Acronym
- MBSR
- Status last verified
- Jul 2022
- First submitted
- 5 Oct 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based Stress Reduction Programme for Reducing the Stress Level and Emotion Regulation of Nursing Students
- ClinicalTrials.gov ID
- NCT05100537
- Acronym / sponsor ID
- MBSR / 0051
- Conditions
- Stress, Emotion Regulation
- Keywords
- Mindfulness, Nursing student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 29 Oct 2021 (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: This research was planned to determine the effect of mindfulness-based stress reduction program on reducing the stress level and emotion regulation of nursing students.
Design: The research was planned as a pretest, posttest, follow-up and randomized controlled study in order to determine the effect of the mindfulness-based stress reduction program on the stress level and emotion regulation of nursing students.
Hypotheses: H1: The perceived stress level scores of nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease compared to the nursing students in the control group.
H2: The perceived stress level of the nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease according to their pretest scores.
H3: Emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the nursing students in the control group.
H4: The posttest and follow-up emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the pretest.
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 Stress Reduction | Experimental | Behavioral: Mindfulness Based Stress ReductionThe Mindfulness Based Stress Reduction program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks. |
| CONTROL GROUP | Active comparator | Other: continuing a routine lifeno intervention |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range is 18-25 years old
- Being a student in the second or third year of the nursing department
- Regular attendance at school
- Not having a communication problem related to vision or hearing
- It was determined as having a score of 26 or more from the perceived stress scale.
Key exclusion criteria (1 listed)
- Have a psychiatric illness
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 Stress ReductionThe intervention has its roots in meditations and yoga practices. However, it is independent of religious purpose or affiliation.The weekly sessions include a range of mental and bodily practices, including awareness of emotions, awareness of thoughts, awareness of sensations. It involves full awareness of daily activities, using the breath as an anchor for attention.In addition to mindfulness practices and experiential work, psychoeducation and participants' sharing will clarify the issues of stress, stress management and how mindfulness is applied in daily situations and interpersonal communication. | Behavioural | Mindfulness Based Stress Reduction |
| continuing a routine lifeNo intervention will be made in the control group. | Other | CONTROL GROUP |
Primary outcome
Perceived Stress Scale
Time frame: For 3 months
The 14-item scale was designed to measure how stressful the individual perceives certain situations in his life. The scale is in 5-point Likert type, ranging from "Never (0)" to "Very often (4)". 7 of the scale items with positive expressions are scored in reverse. The total score from the scale indicates the stress level of the person. A score between 11-26 indicates a low stress level, a score between 27-41 indicates a medium stress level, and a score between 42-56 indicates a high stress level.
Cognitive Emotion Regulation Scale
Time frame: For 3 months
It is a five-point Likert type scale (1 = not at all suitable for me, 2 = somewhat suitable for me, 3 = somewhat suitable for me, 4 = very suitable for me, 5 = completely suitable for me). The scale consists of 36 items in total. Cronbach's alpha value in the original form of the scale. with 67. It is between 81. The scale includes "self-blame", "acceptance", "focus on thought", "positive refocus", "plan refocus", "positive reconsideration", "perspective", "destruction" and "blaming others". It consists of nine sub-dimensions.
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 29 Jul 2022.
- 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 Stress Reduction and continuing a routine life in people with Stress and Emotion Regulation, 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 5 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 29 Jul 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?
Perceived Stress Scale (time frame: For 3 months). 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?
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 29 Jul 2022.