Clinical trial NCT06706505: Mindfulness-Based Art Therapy for Nurses: Difficulties in Emotion Regulation, Burnout, and Psychological Flexibility
Official title: The Effect of Mindfulness Based Art Therapy Applied to Nurses Working in a University Hospital in the Earthquake Zone on Difficulties in Emotion Regulation, Burnout and Psychological Flexibility
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Burnout, Professional
Keywords: art therapy
mindfulness
emotional regulation
burnout
psychological flexibility
nurses
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre-test post-test follow-up and control group experimental study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effects of mindfulness-based art therapy on the difficulties in emotional regulation, burnout, and psychological resilience levels of nurses working in the earthquake-affected region. The main questions it aims to answer are:

Does MBAT reduce the burnout levels of nurses working in the earthquake-affected region? Does MBAT reduce the emotional regulation difficulties of nurses working in the earthquake-affected region? Does MBAT increase the psychological resilience levels of nurses working in the earthquake-affected region? Researchers plan to compare the intervention group where MBAT is applied and the control group where no intervention is applied to see the effects of MBAT on nurses.

Participants :

The intervention group will receive MBAT once a week for 5 weeks. The control group will receive MBAT again after the application is completed, if they are willing.

Follow-up tests will be administered before the intervention, after it is completed, and at the 3rd and 6th months."\*\*

Detailed description: The nursing profession, by its very nature, involves direct interaction with individuals, creating a highly emotionally charged work environment. This necessitates nurses to understand and manage their emotional states. Emotion regulation is a process that determines when, how, and to what extent individuals experience and express their emotions. Disruptions in this process can lead to difficulties in emotion regulation, anxiety, and depression.

Nurses constantly encounter patients experiencing pain, loss, and difficulties. This can lead to emotional burnout and decreased job satisfaction among nurses. Studies have shown that difficulties in emotion regulation and low psychological flexibility contribute to burnout, depersonalization, and emotional exhaustion in nurses. On the other hand, emotion regulation training and the development of psychological flexibility skills can effectively reduce occupational stress for nurses.

Psychological flexibility is defined as the ability to cope with challenges, adapt to changing circumstances, and accept negative emotional experiences. Psychological flexibility enables individuals to better adapt to life's difficulties and improve their overall well-being. For individuals working under constant stress, such as nurses, psychological flexibility is crucial for job satisfaction, quality of life, and overall health.

Mindfulness-Based Art Therapy (MBAT) is a therapeutic approach aimed at developing emotional awareness, acceptance, mental focus, and emotional regulation skills. Combining art therapy and mindfulness techniques, MBAT can help nurses cope with emotional challenges, reduce stress levels, enhance psychological flexibility, and improve overall well-being.

Nurses' emotional regulation and psychological flexibility skills are crucial for both their own psychological well-being and the quality of care they provide. Difficulties in emotion regulation and low psychological flexibility can lead to burnout and other negative consequences. Therapeutic approaches such as Mindfulness-Based Art Therapy (MBAT) offer promising solutions to support nurses' emotional health and create more sustainable professional lives.

Study Design: This study is a randomized controlled trial with a pre-test, post-test, and follow-up design. It aims to determine the effects of mindfulness-based art therapy on nurses' difficulties in emotion regulation, burnout, and psychological flexibility.

Study Setting and Characteristics: The study will be conducted at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital, located in Kahramanmaraş, Turkey. This center provides services in various departments, including internal medicine, surgery, oncology, and psychiatry, with separate units for children and adults. Nurses at this center primarily work in inpatient units, intensive care units, operating rooms, and emergency departments. Their work schedules include both day shifts and rotating shifts.

Population and Sample: The study population consists of all nurses working at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital. Based on information obtained from the institution, the total number of nurses is 500. The sample will include nurses who meet the inclusion criteria. To determine the sample size, the G\*Power program was used. The effect size was calculated based on a similar study in the literature. With an alpha level of 0.05, a power of 0.95, and an effect size of 1.109189, the total sample size was calculated to be 38 (19 in the intervention group and 19 in the control group). Considering a potential dropout rate of 10-20% as reported in previous studies, the sample size was increased by 20%, resulting in a final sample size of 23 nurses in each group.

Pilot Study: Prior to the main study, a pilot study was conducted to evaluate the feasibility of a structured mindfulness-based art therapy intervention. A group of eight volunteer nurses from the outpatient clinics and polyclinics of Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital participated in this pilot intervention.

Study Implementation: The main study will be conducted at Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital following the pilot study. Before the intervention, both the intervention and control groups will be administered the Participant Information Form once, and the Difficulty in Emotion Regulation Scale (Short Form), the Maslach Burnout Inventory, and the Psychological Flexibility Scale three times (pre-test: one week before the MBAT, post-test: one week after the MBAT, follow-up: 3 and 6 months after the MBAT). Following the pre-test, a 5-session MBAT will be initiated for the intervention group. Considering the effectiveness of the intervention and the characteristics of psychological counseling groups, the intervention group will be divided into subgroups. Each subgroup will receive the intervention on different days or times within the same week. After the intervention period and post-test, the MBAT will be applied to the control group.

Data Analysis: Data collected from the study will be analyzed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) V23. To assess normality, the Shapiro-Wilk test will be used. For normally distributed data, independent samples t-test and paired samples t-test will be employed. For non-normally distributed data, the Mann-Whitney U test and the Wilcoxon signed-rank test will be used. The relationship between variables will be examined using Spearman correlation analysis. Data will be presented as mean and standard deviation for normally distributed data and median and range for non-normally distributed data. Categorical data will be analyzed using the chi-square test and presented as frequencies and percentages.

Ethical Considerations: Ethical approval has been obtained from the Ethics Committee of Gazi University (dated 16.04.2024, number 07) and the relevant departments of Kahramanmaraş Sütçü İmam University Health Practices and Research Hospital. Permission to use the data collection tools was obtained via email from the authors who conducted the validity and reliability studies. Before the study began, participants were provided with detailed information about the study's purpose, procedures, and expected outcomes. Written informed consent was obtained from each participant in the pre-test, intervention, and control groups. The researcher conducting the study possesses the necessary qualifications and certifications to implement the intervention.

Eligibility criteria: Inclusion Criteria:

* To have provided active care for individuals affected by the earthquake for at least three months
* To voluntarily agree to participate in the study.

Exclusion Criteria:

* To have received or be currently receiving training or individual/group therapy in art therapy or mindfulness.
* To have a condition that would prevent them from actively participating in the sessions, comprehending the scales, and completing them.
* To fail to attend two consecutive study sessions for any reason
* To voluntarily withdraw from the study at any time

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
timeFrame: 7 months
measure: Maslach Burnout Inventory (MBI)
timeFrame: 7 months
measure: The Psychological Flexibility Scale
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
state: Onikişubat
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Mehtap Ağaç, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Satı Demir, Professor
role: STUDY_CHAIR
References:
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citation: Yiğit İ, Guzey Yiğit, M. Psychometric Properties of Turkish Version of Difficulties in Emotion Regulation Scale-Brief Form (DERS-16). Current Psychology. 2019: 38: 1503-1511. https://doi.org/10.1007/s12144-017-9712-7.
citation: Gratz, KL, Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment. 2004: 26: 41-54. https://doi.org/10.1023/B:JOBA.0000007455.08539.94