- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04987905
The Effect of MIND-BE Program on Mental Health Parameters (Mindfulness Based Empowerment) (MIND-BE)
2. června 2022 aktualizováno: Hilal Altundal
The Effect of MIND-BE Program Applied to Intensive Care Nurses on Mental Health Parameters (Mindfulness Based Empowerment)
This study will be carried out in a pre-test-post-test, randomized controlled (parallel), experimental order in order to examine the effect of the MIND-BE program applied to intensive care nurses on mental health parameters.
The hypothesis of this study is that MIND-BE program increases resilience, posttraumatic growth, mindfulness, self-compassion levels, and reduces mental symptoms.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
In the study, the MIND-BE program will be applied to the nurses (n=49) in the intervention group.
Considering the studies on mindfulness on nurses, it is planned to practice mindfulness for 60 minutes once a week for 8 weeks.
Mindfulness practice will be done online using appropriate platforms on the days and hours determined by Hilal Altundal (H.A.), who has a Mindfulness Institute-approved document.
In the control group (n=49), no intervention will be made for 8 weeks.
Results will be collected through data collection forms before the MIND-BE program, after the MIND-BE program is completed (8th week), and one month after the MIND-BE program is completed (12th week).
The data collection forms applied to all nurses in the intervention and control groups at the beginning of the study will be applied again at the end of the 8th and 12th weeks.
The primary expected outcome of the study is the effect of the MIND-BE program on nurses' resilience, posttraumatic growth, mindfulness, and self-compassion.
The secondary expected result of the study is to determine the effect of the MIND-BE program on the mental health of nurses.
Typ studie
Intervenční
Zápis (Aktuální)
80
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Mersin, Krocan, 33343
- Mersin University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 65 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Between the ages of 18-65
- Written consent was obtained before participating in the study.
- Working as a nurse in the relevant institution on the dates of the study
- Not receiving any other psychological therapy during their working dates
- No prior meditation experience
- No practice in daily mind-body practices
- The participants (nurses) do not have any physical/mental disability or limitation and disease that would prevent them from participating in the program (no psychiatric diagnosis, no psychiatric medication, previous ear, brain, spinal cord surgery, acute retinal hemorrhage, vertebral fracture, and diaphragm rupture, hiatus or abdominal hernia, acute myocardial infarction, stable uncontrolled angina pectoris, severe coronary artery disease, congestive heart failure, severe valvular heart disease, acute myocarditis, acute and unstable musculoskeletal injuries, uncontrollable systemic hypertension, severe dementia and behavioral disorders) individuals are included in the study. will be included.
Exclusion Criteria:
- The participants (nurses) who could not complete eight sessions for different reasons and had to leave halfway through (illness, moving, changing service, etc.)
- The participants who participated in more than 70% of a mindfulness-based intervention prior to the study
- It is determined/specified that there are other existing health problems (physical/mental) after starting the education.
- Participating in less than 70% of the eight-week program
- Doing less than 70% of formal and informal practices
- Who left the program voluntarily
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental Group
In the study, for 60 minutes once a week for 8 weeks the MIND-BE program will be applied to nurses.
The program includes formal and informal practices of mindfulness ("Getting started, Introduction to MIND-BE, Noticing the autopilot, Power of attention, Simple awareness, Eating awareness, Body awareness, Breath awareness, Sitting awareness, Stress and reactions, Vision awareness, Challenging emotions and situations in business life, Awareness in business life, Awareness and communication, Awareness and compassion, Developing your own practice).
In addition to these, nurses will be required to keep a diary of the program.
This app contains basic mindfulness exercises and does not pose any health risks to practitioners.
While the MIND-BE program is carried out in the online environment, the cameras of the nurses in the experimental group will be turned on and the researcher who made the application will be able to see each nurse.
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In the study, for 60 minutes once a week for 8 weeks MIND-BE program will be applied to nurses.
The program includes formal and informal practices of mindfulness ("Getting started, Introduction to MIND-BE, Noticing the autopilot, Power of attention, Simple awareness, Eating awareness, Body awareness, Breath awareness, Sitting awareness, Stress and reactions, Vision awareness, Challenging emotions and situations in business life, Awareness in business life, Awareness and communication, Awareness and compassion, Developing your own practice).
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Žádný zásah: Control Group
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
After all data are collected (after the 12th week), the training content will be explained to the nurses in the control group and the MIND-BE program will be started for them as well.
In this way, both groups will benefit from this program.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Resilience will evaluate using The Resilience Scale for Adults
Časové okno: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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It was developed by Friborg et al.
The Turkish validity and reliability of the scale was done by Basım and Çetin.
The 33-item scale consists of six sub-dimensions: "Self Perception", "Future Perception", "Structural Style", "Social Competence", "Family Cohesion" and "Social Resources".
Opposite each item in the scale, there are five boxes with changing expressions for each question and showing a five-point Likert structure.
Questions 1,3,4,8,11,12,13,14,15,16,23,24,25,27,31,33 in the scale without any cutoff point are reverse coded.
The scoring of the boxes ranges from 1 to 5 for flat coded items; from 5 to 1 for reverse coded items.
The total Cronbach's alpha coefficient of the scale is 0.86, and the Cronbach's alpha coefficients of the sub-dimensions range from 0.66 to 0.81.
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Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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Posttraumatic growth will evaluate using The Post Traumatic Growth Inventory
Časové okno: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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It was developed by Tedeschi and Calhoun (1996).
The Turkish validity and reliability of the scale was done by Kağan et al. (2012).
Consisting of 21 items in total, the scale has a six-grade Likert structure (No way (0), Very little (1), A little (2), Moderate (3), Quite a lot (4), Very much (5)) .
The scale consists of three sub-dimensions: "self-perception", "change in philosophy of life" and "relationship with others".
An increase in the scores obtained from the scale without any cut-off point indicates that the level of post-traumatic growth increases.
Similarly, the increase in the scores obtained from the sub-dimensions indicates that the sub-dimensions with increasing scores are used more.
The Cronbach's alpha values of the scale ranged from 0.92, and the Cronbach's alpha values of the sub-dimensions ranged from 0.77 to 0.88.
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Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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Mindfulness will evaluate using The Mindful Attention Awareness Scale
Časové okno: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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The Mindful Attention Awareness Scale (MAAS), developed by Brown and Ryan (2003), is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life.
MAAS has a single factor structure and gives a single total score.
High scores on the scale indicate high conscious awareness.
The MAAS is a 6-point Likert-type scale (almost always, often, sometimes, rarely, quite rarely, almost never).
The internal consistency coefficient was determined as 0.80 in the Turkish adaptation study of the MAAS by Özçiçek et al. (2011).
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Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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Self-compassion will evaluate using The self-compassion scale
Časové okno: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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Developed by Neff (2003), Akın et al. (2007), the self-compassion scale (self-compassion scale) consists of 26 items and six subscales (self-compassion, self-judgment, shared human experience, isolation, mindfulness, and hyper-identification).
In this scale, which has a five-point Likert-type rating; almost never (1), rarely, sometimes, often, almost always (5).
In the study of Akın et al. (2007), the internal consistency of the subscales ranged between 0.72 and 0.80.
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Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Mental symptom will evaluate using The Brief Symptom Inventory
Časové okno: Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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The Brief Symptom Inventory (BSI) is based on the 90-item Symptom Check List (SCL-90) distributed over nine factors, and is a 53-item scale consisting of the items with the highest load in each factor.
The scale is a Likert-type self-evaluation inventory developed by Deregotis in 1992.
The scale is the short form of the Mental Symptom Checklist and consists of five subscales and three global indexes.
As a result of these studies, in the Turkish adaptation of the scale by Şahin and Durak (2002), the BSI was organized into five subsections as "Anxiety", "Depression", "Negative Self", "Somatization" and "Hostility".
An increase in the total score indicates an increase in the weight of the question.
There is no cut-off value for BSI.
The alpha coefficients found for the subscales of BSI in the study were Depression, α=0.88; anxiety, α=0.87; negative self, α=0.87; somatization, α=0.75; hostility is listed as α=0.76.
The points that can be obtained from the inventory range from 0 to 212.
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Change from before implementation, after mindfulness practice is completed (8th week), and one month after mindfulness practice is completed (12th week)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Mualla Yılmaz, Professor, Mersin University, Faculty of Nursing, Ciftlikkoy Campus, 33343, Yenisehir, Mersin
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
13. dubna 2021
Primární dokončení (Aktuální)
24. září 2021
Dokončení studie (Aktuální)
31. března 2022
Termíny zápisu do studia
První předloženo
28. července 2021
První předloženo, které splnilo kritéria kontroly kvality
28. července 2021
První zveřejněno (Aktuální)
3. srpna 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. června 2022
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. června 2022
Naposledy ověřeno
1. června 2022
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Hilal Altundal
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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