Behavior, HealthPRoNMBSRNCT05606861
Mindfulness Based Interventions in Pediatric Nurses
A study testing Mindfulness Based Interventions in Pediatric Nurses in people with Behavior, Health, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction Intervention on increasing the psychological resilience of pediatric nurses. Design: This is a single-center, single-blind, randomized controlled trial Method: In the study, the group in which the Mindfulness-Based Stress Reduction… Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Mindfulness Based Interventions in Pediatric Nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2018to 30 Jan 2019
- 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 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Working for at least one year in the children's ward,
- Older than 18 years of age,
- The working program must be suitable for the experiment schedule.
Who cannot join
- Clinical diagnosis for a psychiatric disorder,
- Long experience of meditation or yoga.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mindfulness Based Stres Reduction Intervention on Psychological Resilience of Child Nurses: Randomized Controlled Trial
The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction Intervention on increasing the psychological resilience of pediatric nurses.
Design: This is a single-center, single-blind, randomized controlled trial
Read more
Method:
In the study, the group in which the Mindfulness-Based Stress Reduction Initiative was applied was taken as the experimental (n: 15), the unstructured group (n: 14) in which the stressful life experiences were shared as the control group. Due to the limited number of the research population (N:56), 29 nurses who agreed to participate in the study and met the inclusion criteria were included in the study without using the sampling method. This research was conducted with pediatric nurses working in the inpatient units of a children's hospital affiliated to a university in Izmir. Stress reduction training based on mindfulness, including meditation and breathing techniques, was given to the experimental group for 5 weeks. No intervention was applied to the control group.
The primary outcomes of the study were measured using the Perceived Stress Scale, the Self-Compassion Scale, the Interpersonal Reactivity Index, and Psychological Resilience Scale for Adults.
This study is important because it is the first randomized controlled study on the effect of Mindfulness Based Stress Reduction (MBSR) on resilience in nurses in our country.
In addition, the results will contribute to preventing nurses from leaving the profession in the early period, providing more flexibility and therefore safe patient care to the nursing workforce, especially in today's health system where there is a heavy nursing shortage.
- Conditions
- Behavior, Health
- Being tested
- Mindfulness Based Interventions in Pediatric Nurses
- Keywords
- Pediatric Nurse, Psychological Resilience, Mindfulness
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Interventions in Pediatric NursesOther
This intervention are structured mindfulness program including meditation and breathing techniques .
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Mindfulness Based Intervention in pediatric nurses components was applied to this group. Receives: Other: Mindfulness Based Interventions in Pediatric Nurses |
| Control group | No intervention | No procedure was conducted the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Level
Perceived Stress Scale:The lowest score which can be obtained on the scale is 0, and the highest is 56.Higher total score means higher perceived stress level.
Measured: For 9 weeks
Psychological Resilience Level
Psychological Resilience Scale for Adults: The minimum score on the scale is 33, and the maximum is 165. A low score on the scale indicates that the person's psychological resilience level is inadequate.
Measured: For 9 weeks
Empathy Level
Interpersonal Reactivity Index: The scale measures different aspects of empathy. For example, the perspective-taking dimension expresses better interpersonal functioning and higher self-esteem, while the empathetic thinking dimension expresses a consistent relationship with social competence or self-esteem.
Measured: For 9 weeks
Self Compassion Level
The Self-Compassion Scale consists of 26 Likert type items and six sub-dimensions.A higher total score on the scale indicates a higher level of self-compassion perceived by the participants.
Measured: For 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start20 Nov 2018
- Primary completion28 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülün Liman, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606861
- Sponsor's protocol ID
- 69631334-300
- Acronym
- PRoNMBSR
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 7 Nov 2022
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness Based Stres Reduction Intervention on Psychological Resilience of Child Nurses: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05606861
- Acronym / sponsor ID
- PRoNMBSR / 69631334-300
- Conditions
- Behavior, Health
- Keywords
- Pediatric Nurse, Psychological Resilience, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 7 Nov 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.
The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction Intervention on increasing the psychological resilience of pediatric nurses.
Design: This is a single-center, single-blind, randomized controlled trial
Method:
In the study, the group in which the Mindfulness-Based Stress Reduction Initiative was applied was taken as the experimental (n: 15), the unstructured group (n: 14) in which the stressful life experiences were shared as the control group. Due to the limited number of the research population (N:56), 29 nurses who agreed to participate in the study and met the inclusion criteria were included in the study without using the sampling method. This research was conducted with pediatric nurses working in the inpatient units of a children's hospital affiliated to a university in Izmir. Stress reduction training based on mindfulness, including meditation and breathing techniques, was given to the experimental group for 5 weeks. No intervention was applied to the control group.
The primary outcomes of the study were measured using the Perceived Stress Scale, the Self-Compassion Scale, the Interpersonal Reactivity Index, and Psychological Resilience Scale for Adults.
This study is important because it is the first randomized controlled study on the effect of Mindfulness Based Stress Reduction (MBSR) on resilience in nurses in our country.
In addition, the results will contribute to preventing nurses from leaving the profession in the early period, providing more flexibility and therefore safe patient care to the nursing workforce, especially in today's health system where there is a heavy nursing shortage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Mindfulness Based Interventions in Pediatric NursesMindfulness Based Intervention in pediatric nurses components was applied to this group. |
| Control group | No intervention | –No procedure was conducted the control group. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Working for at least one year in the children's ward,
- Older than 18 years of age,
- The working program must be suitable for the experiment schedule.
Key exclusion criteria (2 listed)
- Clinical diagnosis for a psychiatric disorder,
- Long experience of meditation or yoga.
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 Interventions in Pediatric NursesThis intervention are structured mindfulness program including meditation and breathing techniques . | Other | Intervention group |
Primary outcome
Perceived Stress Level
Time frame: For 9 weeks
Perceived Stress Scale:The lowest score which can be obtained on the scale is 0, and the highest is 56.Higher total score means higher perceived stress level.
Psychological Resilience Level
Time frame: For 9 weeks
Psychological Resilience Scale for Adults: The minimum score on the scale is 33, and the maximum is 165. A low score on the scale indicates that the person's psychological resilience level is inadequate.
Empathy Level
Time frame: For 9 weeks
Interpersonal Reactivity Index: The scale measures different aspects of empathy. For example, the perspective-taking dimension expresses better interpersonal functioning and higher self-esteem, while the empathetic thinking dimension expresses a consistent relationship with social competence or self-esteem.
Self Compassion Level
Time frame: For 9 weeks
The Self-Compassion Scale consists of 26 Likert type items and six sub-dimensions.A higher total score on the scale indicates a higher level of self-compassion perceived by the participants.
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 Nov 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 Interventions in Pediatric Nurses in people with Behavior, Health, run by Ege 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 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: finished, as of the sponsor's last update on 7 Nov 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 Level (time frame: For 9 weeks). The study lists 4 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 7 Nov 2022.