Psychological ResilienceNCT05129579
Psychological Resilience and Psychological Well-being of Intensive Care Nurses
A study testing Mindfulness Based Stress Reduction Intervention in people with Psychological Resilience and Well-being, run by İstanbul Yeni Yüzyıl Üniversitesi.
Trial summary
Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on the psychological resilience and well-being of intensive care nurses. Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Resilience, Well-being
- What is being tested?
- Mindfulness Based Stress Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having Having a working time of at least 6 months in the intensive care unit,
- No barriers to accessing technology for participation in the online training program,
- Absence of a communication barrier related to vision and hearing
Who cannot join
- Working in the intensive care unit for less than 6 months
- Working in the intensive care unit due to temporary assignment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of the Mindfulness Based Stress Reduction Intervention on Psychological Resilience and Psychological Well-being of Intensive Care Nurses
Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on the psychological resilience and well-being of intensive care nurses.
Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.
Read more
Hypotheses: H1: The resilience level scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the nurses in the control group.
H2: Nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase their well-being level scores compared to the nurses in the control group.
H3: The psychological resilience level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores.
H4: The well-being level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.
- Conditions
- Psychological Resilience, Well-being
- Being tested
- Mindfulness Based Stress Reduction Intervention, no intervention
- Keywords
- Mindfulness, Intensive Care Nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction InterventionBehavioural
Mindfulness Based Stress Reduction intervention 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 90 minute sessions, once per week for eight weeks.
no interventionOther
No intervention will be made in the control group.
| Study group | Role | What they receive |
|---|---|---|
| MBRSEG | Experimental | The group in which the mindfulness-based stress reduction intervention will be implemented. Receives: Behavioral: Mindfulness Based Stress Reduction Intervention |
| control group | Other | The group to which mindfulness-based stress reduction intervention will not be applied Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Resilience Level
Psychological Resilience Scale for Adults: The scale consists of 33 items; it includes 6 sub-dimensions: The structural style (3,9,15,21) and perception of future (2,8,14,20) subdimensions were measured by 4 items each, the family cohesion (5,11,17,23,26,32), perception of self (1,7,13,19,28,31,), and social competence (4,10,16,22,25,29) sub-dimensions were measured by 6 items each, and the social resources (6,12,18,24,27,30,33) sub-dimension was measured by 7 items. The score that can be obtained from the scale varies from 33 to 165.
Measured: for 3 months
Psychological Well-being Level
Psychological Well-Being Scale: The items of the scale are answered between 1 and 7, as I strongly disagree (1) and I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strengths.
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 posted22 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological ResilienceStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İstanbul Yeni Yüzyıl Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve BAT TONKUŞ, İstanbul Yeni Yüzyıl Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129579
- Sponsor's protocol ID
- IstanbulYeniYU
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mindfulness Based Stress Reduction Intervention on Psychological Resilience and Psychological Well-being of Intensive Care Nurses
- ClinicalTrials.gov ID
- NCT05129579
- Acronym / sponsor ID
- IstanbulYeniYU
- Conditions
- Psychological Resilience, Well-being
- Keywords
- Mindfulness, Intensive Care Nurses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- İstanbul Yeni Yüzyıl ÜniversitesiUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 22 Nov 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 study aims to determine the impact of mindfulness-based stress reduction programs on the psychological resilience and well-being of intensive care nurses.
Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.
Hypotheses: H1: The resilience level scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the nurses in the control group.
H2: Nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase their well-being level scores compared to the nurses in the control group.
H3: The psychological resilience level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores.
H4: The well-being level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBRSEG | Experimental | Behavioral: Mindfulness Based Stress Reduction InterventionThe group in which the mindfulness-based stress reduction intervention will be implemented. |
| control group | Other | Other: no interventionThe group to which mindfulness-based stress reduction intervention will not be applied |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having Having a working time of at least 6 months in the intensive care unit,
- No barriers to accessing technology for participation in the online training program,
- Absence of a communication barrier related to vision and hearing
Key exclusion criteria (2 listed)
- Working in the intensive care unit for less than 6 months
- Working in the intensive care unit due to temporary assignment
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 Reduction InterventionMindfulness Based Stress Reduction intervention 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 90 minute sessions, once per week for eight weeks. | Behavioural | MBRSEG |
| no interventionNo intervention will be made in the control group. | Other | control group |
Primary outcome
Psychological Resilience Level
Time frame: for 3 months
Psychological Resilience Scale for Adults: The scale consists of 33 items; it includes 6 sub-dimensions: The structural style (3,9,15,21) and perception of future (2,8,14,20) subdimensions were measured by 4 items each, the family cohesion (5,11,17,23,26,32), perception of self (1,7,13,19,28,31,), and social competence (4,10,16,22,25,29) sub-dimensions were measured by 6 items each, and the social resources (6,12,18,24,27,30,33) sub-dimension was measured by 7 items. The score that can be obtained from the scale varies from 33 to 165.
Psychological Well-being Level
Time frame: for 3 months
Psychological Well-Being Scale: The items of the scale are answered between 1 and 7, as I strongly disagree (1) and I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strengths.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction Intervention in people with Psychological Resilience and Well-being, run by İstanbul Yeni Yüzyıl Üniversitesi.
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 2 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 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Merve Bat Tonkus, PhD Cand (+905055951889, batmerve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Resilience Level (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 22 Nov 2021.