AzTrials
AzTrials

NursesNCT06454526

Effects of Mindfulness-Based Program on Individual and Organizational Output of Frontline Manager Nurses:

A study testing Mindfulness Based Program in people with Nurses and Mindfulness Training, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this randomized controlled study is to examine the effects of a mindfulness program applied to nurse managers on individual and organizational results. In the research, the Mindfulness-Based Program will be examined as the dependent variable, and the conscious awareness level of manager nurses… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Nurses, Mindfulness Training
What is being tested?
Mindfulness Based Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Dec 2023to 30 Jun 2024
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Serving as a frontline nurse manager
  • At least six months of managerial experience
  • Not having participated in an eight-week Mindfulness-Based Program before

Who cannot join

  • Serving as a lower-level manager for less than six months
  • Having previously participated in an eight-week Mindfulness-Based Program
  • Termination Criteria:
  • Participant withdraws from the study voluntarily.
  • Participant's task change
  • Participant leaving employment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa Graduate Education Institute

    Istanbul, Avcılar, 34320

Other trials in Turkey (Türkiye)

About this study

Official title: The Mindfulness Level of Manager Nurses, Leadership Behavior, Job Satisfaction, Job Performance, Burnout, Conflict Approach and Intention to Leave Will be Examined as Independent Variables.

The purpose of this randomized controlled study is to examine the effects of a mindfulness program applied to nurse managers on individual and organizational results. In the research, the Mindfulness-Based Program will be examined as the dependent variable, and the conscious awareness level of manager nurses, leadership behavior, job satisfaction, job performance, burnout, conflict approach and intention to leave will be examined as independent variables. The study was planned on the grounds that nurses need to be able to cope better with stress, reduce anxiety and burnout, and provide better job satisfaction in order to maintain a safe working life due to the increasing workload and difficulties of the healthcare system.

Hypotheses of the research are as follows:

Read more

H0: Mindfulness-Based Program is not effective on mindfulness, leadership behaviors, job satisfaction, job performance, burnout, conflict approach and intention to leave in manager nurses.

H1: Mindfulness-Based Program is effective on mindfulness, leadership behaviors, job satisfaction, job performance, burnout, conflict approach and intention to leave in manager nurses.

The population of the research will be all the responsible nurses working as low-level managers at Koç University Hospital and Kanuni Sultan Süleyman Training and Research Hospital. Responsible nurses who meet the sampling criteria and volunteer to participate in the study will be included in the study, and the participants will be randomly divided into intervention and control groups.

Read the detailed description

In Turkey, studies on mindfulness in the nursing sample were carried out mostly descriptively, and nurses mindfulness levels were found to be at a medium level (Aşık and Albayrak, 2021; Özaydın, 2019). Considering the increasing workload and difficulties of the healthcare system, healthcare facility managers need to pay attention to the issue so that nurses can better cope with stress and reduce their anxiety and burnout in order to maintain a safe working life. This is a prerequisite for providing safe service to patients by providing better job satisfaction and performance. It may be possible to improve individual, team and organizational results with programs aimed at increasing the conscious awareness levels of manager nurses.

The purpose of this randomized controlled study is to examine the effects of a mindfulness program applied to nurse managers on individual and organizational results. In the research, the Mindfulness-Based Program will be examined as the dependent variable, and the conscious awareness level of manager nurses, leadership behavior, job satisfaction, job performance, burnout, conflict approach and intention to leave will be examined as independent variables. The study was planned on the grounds that nurses need to be able to cope better with stress, reduce anxiety and burnout, and provide better job satisfaction in order to maintain a safe working life due to the increasing workload and difficulties of the healthcare system.

Hypotheses of the research are as follows:

H0: Mindfulness-Based Program is not effective on mindfulness, leadership behaviors, job satisfaction, job performance, burnout, conflict approach and intention to leave in manager nurses.

H1: Mindfulness-Based Program is effective on mindfulness, leadership behaviors, job satisfaction, job performance, burnout, conflict approach and intention to leave in manager nurses.

The population of the research will be all the responsible nurses working as low-level managers at Koç University Hospital and Kanuni Sultan Süleyman Training and Research Hospital. Responsible nurses who meet the sampling criteria and volunteer to participate in the study will be included in the study, and the participants will be randomly divided into intervention and control groups.

The responsible nurses working at Koç University Hospital and Kanuni Sultan Süleyman Training and Research Hospital will be listed and the eligibility criteria for participation in the study (not having participated in the mindfulness program before) will be questioned. Participants included in the study will be listed and randomly divided into intervention and control groups. Randomization; Control and intervention groups will be assigned to the intervention or control group in the order of arrival, in line with the randomization list prepared in the Excel program using the random numbers method.

Before the implementation of the Mindfulness-Based Program , which will be implemented as an intervention in the research, all participants in the intervention and control groups were asked to use the Introductory Information Form, Conscious Awareness Scale, Minnesota Job Satisfaction Scale, Maslach Burnout Scale, Job Performance (Task/Contextual Performance) Scale, Rahim Organizational Conflict Inventory-2. Data (pretest) will be collected with (ROCI II) and the Intention to Leave Scale.

Conscious Awareness, job satisfaction, burnout, job performance and conflict inventory data will be collected again immediately (posttest) and three months later (follow-up) after the 8-week Mindfulness-Based Program implementation.

Data will be collected on charge nurses evaluations of leadership behaviors and intention to leave the subordinates they work with. For this purpose, the Introductory Information Form, Intention to Leave Scale and Leadership Behavior Scale were collected from the subordinates of the responsible nurses in the intervention and control group, before (pre-test), after (post-test) and three months later (follow-up) the intervention and control group. Data will be collected on a timely basis.

Being tested
Mindfulness Based Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based ProgramBehavioural

    Mindfulness Based Program is an 8-week program with a total of 25 hours. The program, which consists of lectures, meditation and sharing areas, consists of the following topics: Six Senses and Pleasure, Mindfulness and Mind, Get Out of the Head and Enter the Body, Compassion, Meeting Challenges, Stress Reactions and Healing, Retreat Silence Day, Neuroplasticity and the Changing Brain and Wise Living.

Study groups in NCT06454526
Study groupRoleWhat they receive
ExperimentExperimentalThe group to which the 8-week Mindfulness-Based program will be applied.
Receives: Behavioral: Mindfulness Based Program
ControlNo interventionThe group in which the 8-week Mindfulness-Based program will not be applied.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Introductory Information Form

    The Introductory Information Form, created by the researchers as a result of literature review, consists of 13 items. The content of the Form includes questions regarding sociodemographic (age, gender, educational status, marital status), professional characteristics (years of experience, management time, unit worked) and conscious awareness practices.

    Measured: through study completion, an average of three months

  2. Conscious awareness scale (BIPÖ)

    The Conscious Awareness Scale (BIPQ), developed by Brown and Ryan in 2003, was adapted into Turkish by Özyesil et al. in 2011. The scale consists of 15 items and is one-dimensional. The Likert-type scale is rated by participants on a scale of 1 to 6 (1: almost always, 6: almost never). As the total score obtained from the scale increases, the level of conscious awareness increases. A minimum of 15 and a maximum of 90 points are taken from the scale. An increase in the score obtained from the scale indicates that the level of conscious awareness is high.

    Measured: through study completion, an average of three months

  3. Leadership Behavior Scale

    The leadership behavior scale developed by Ekvall and Arvonen (1991) was adapted into Turkish by Tengilimoglu in 2005. The scale consists of 36 items and has 3 subscales. The Likert-type scale, which includes items expressing employee, task and change-oriented leadership behavior, is graded as (1) Strongly disagree, (2) Disagree, (3) Undecided, (4) Agree, (5) Strongly agree.

    Measured: through study completion, an average of three months

  4. Minnesota Job Satisfaction Scale

    Minnesota Job Satisfaction Scale, developed by Weiss, Dawis, England \& Lofquist in 1967, was adapted into Turkish by Baycan (1985). The scale consists of three sub-dimensions: internal, external and general satisfaction and 20 items. It was made on a Likert type 5-point scale and was evaluated as (1) Very Dissatisfied, (2) Dissatisfied, (3) Undecided, (4) Satisfied, (5) Very Satisfied.

    Measured: through study completion, an average of three months

  5. Maslach Burnout Scale

    Maslach Burnout Scale, developed by Maslach and Jackson (1986), was adapted into Turkish by Ergin (1992). The scale consists of 22 items and evaluates burnout in three subscales (emotional exhaustion, depersonalization and personal accomplishment). A high score from the emotional exhaustion and depersonalization sub-dimensions of the scale and a low score from the personal success sub-dimension indicates that the level of burnout is high.

    Measured: through study completion, an average of three months

  6. Job Performance (Task/Contextual Performance) Scale

    The scale developed by Goodman and Svyantek (1999) was adapted into Turkish by Ünlü and Yürür in 2011. The scale, which includes 25 items, has two sub-dimensions: contextual performance and task performance. The scale is rated as a five-point Likert, "Definitely True-5 points" and "Definitely Not True-1 point".

    Measured: through study completion, an average of three months

  7. Rahim Organizational Conflict Inventory-2 (ROCI II)

    "The Rahim Organizational Conflict Inventory II-ROCI II" developed by Rahim (1983) was adapted into Turkish by Kozan and Ergin (1999). The five-point Likert type scale ((1) Strongly disagree, (2) Disagree, (3) Undecided, (4) Agree, (5) Strongly agree) consists of 31 items in total. Conflict management approaches have five sub-dimensions: Integrating, Compromising, Dominating, Avoiding, and Compromising.

    Measured: through study completion, an average of three months

  8. Intention to Leave Scale

    The Intention to Leave Scale, developed by Mobley, Horner and Hollingsworth (1978), was adapted into Turkish by Örücü and Özafşarlıoğlu (2013). The five-point Likert scale ((1) Strongly disagree, (2) Disagree, (3) Undecided, (4) Agree, (5) Strongly agree) type consists of 3 items and has no sub-dimensions.

    Measured: through study completion, an average of three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start21 Dec 2023
  3. Primary completion8 Feb 2024
  4. Study completion30 Jun 2024 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454526
Sponsor's protocol ID
2022.275.IRB3.114
Status last verified
Jun 2024
First submitted
5 Jun 2024
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ghawadra SF, Abdullah KL, Choo WY, Phang CK. Mindfulness-based stress reduction for psychological distress among nurses: A systematic review. J Clin Nurs. 2019 Nov;28(21-22):3747-3758. doi: 10.1111/jocn.14987. Epub 2019 Jul 22.

    PubMed 31267619
  • Cummings GG, Tate K, Lee S, Wong CA, Paananen T, Micaroni SPM, Chatterjee GE. Leadership styles and outcome patterns for the nursing workforce and work environment: A systematic review. Int J Nurs Stud. 2018 Sep;85:19-60. doi: 10.1016/j.ijnurstu.2018.04.016. Epub 2018 May 3.

    PubMed 29807190
  • Janssen M, Heerkens Y, Kuijer W, van der Heijden B, Engels J. Effects of Mindfulness-Based Stress Reduction on employees' mental health: A systematic review. PLoS One. 2018 Jan 24;13(1):e0191332. doi: 10.1371/journal.pone.0191332. eCollection 2018.

    PubMed 29364935
  • Wong CA, Cummings GG, Ducharme L. The relationship between nursing leadership and patient outcomes: a systematic review update. J Nurs Manag. 2013 Jul;21(5):709-24. doi: 10.1111/jonm.12116.

    PubMed 23865924

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Program in people with Nurses and Mindfulness Training, run by Istanbul University - Cerrahpasa 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 6 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 12 Jun 2024. 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?

Results are not available in the source record.

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?

Introductory Information Form (time frame: through study completion, an average of three months). The study lists 8 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 NCT06454526, which also lists 4 linked publications.

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 12 Jun 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in