The Effect of MIND-BE Program on Mental Health Parameters (Mindfulness Based Empowerment)

NCT ID: NCT04987905

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Resilience Posttraumatic Growth Mindfulness Self-compassion Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two-arm, randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Participants and the researcher who carried out the application Hilal Altundal (H. A.) cannot be blinded due to the nature of the study. When the study is completed, the control and experimental groups will be coded as A and B and the data will be transferred to the computer environment by an independent researcher. The data coded as A and B will be analyzed by a statistician and the findings will be reported.

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness

Intervention Type OTHER

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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role collaborator

Hilal Altundal

OTHER

Sponsor Role lead

Responsible Party

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Hilal Altundal

Research Assistant, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mualla Yılmaz, Professor

Role: STUDY_DIRECTOR

Mersin University, Faculty of Nursing, Ciftlikkoy Campus, 33343, Yenisehir, Mersin

Locations

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Mersin University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Hilal Altundal

Identifier Type: -

Identifier Source: org_study_id

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