- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634343
Laughter Therapy and Mindfulness Practices in Nurses
The Effect of Laughter Therapy and Mindfulness Practices Upon Nurses' Fatigue and Job Performance Perception and Attention Level
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nagihan KÖROĞLU KABA
- Phone Number: +90 542 309 91 61
- Email: nkoroglu@bayburt.edu.tr
Study Locations
-
-
-
Bayburt, Turkey
- Bayburt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Working as a nurse for at least 6 months in the hospital where the research will be conducted,
- Volunteering to participate in the study,
- It is a shift/alternate work.
Exclusion Criteria:
- Being a non-nursing staff (midwife, health technician, physician, etc.),
- Being pregnant,
- Having been diagnosed with color blindness,
- Being allowed or reported in the process of data collection,
- Continuous day or night work,
- Participating in individual psychotherapy or group intervention programs
- Having been diagnosed with cardiovascular diseases such as hypertension and arrhythmia,
- Having experience in taking medication and meditation for psychiatric reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laughter Group
The laughter therapy program consists of 16 sessions, twice a week for eight weeks.
Each session; It is planned to last 30-45 minutes with a maximum of 25 nurses.
|
Laughter Therapy, also called therapeutic laughter; It is a kind of exercise that combines unconditional laughter and breathing techniques to reduce pain and stress and to give the individual a general sense of well-being.
Laughter therapy is a method of simply "laughing for no reason" in which the person interacts in a group setting with improvisational or pantomime-like exercises and childlike play without humor, jokes or funny incidents.
Thus, it is aimed to benefit from laughter.
|
Experimental: Mindfulness Group
The mindfulness practice program consists of 16 sessions, twice a week for eight weeks.
Each session is planned to last 45-60 minutes with a maximum of 25 nurses.
|
Mindfulness is purposefully drawing attention in the desired direction so that we can stay in the present moment without judgment.
It is also defined as a conscious understanding of what is happening in the moment we live in with an open and loving attitude.
According to another definition, mindfulness includes paying attention to what is happening in the present moment, noticing the quality of this attention, and accepting what is noticed without judgment.
With conscious awareness, the individual discovers how to live in harmony with all the events that take place in the present moment, place and time, without any evaluation, rather than the sorrows and regrets of the past, the anxieties and worries of the future.
Mindfulness helps us to relate to our experiences by enabling us to see the positive-negative, good-bad experiences we have had objectively.
|
No Intervention: Control Group
No intervention was made in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal Information Form
Time Frame: First day
|
This form, developed by the researcher, consists of 6 questions in total, including age, gender, marital and educational status, years of professional experience, and service of the nurses.
|
First day
|
Chalder Fatigue Scale
Time Frame: First day
|
The scale was developed by Chalder et al. in 1993 to measure the severity of fatigue perceived by individuals during the last month in clinical and community samples.
The scale, which is self-report and 4-point Likert type, consists of 11 items and two sub-dimensions as physical and mental fatigue.
The physical fatigue subsection score of the scale ranges from 0-21, the mental fatigue subsection score ranges from 0-12, and the total fatigue score ranges from 0-33.
The total fatigue score is obtained by summing the scores of all items.
High scores indicate greater fatigue severity.
|
First day
|
Computer-Based Sustainable Attention Test
Time Frame: First day
|
Developed by Haladjian and Pylyshyn in 2006, the test was adapted into Turkish by Ilgaz et al. in 2019.
The test measures the sustained attention levels of individuals; easy, medium, consists of sessions at difficult levels.
The total score that can be obtained from each level varies between 0-10.
Each step of the test is repeated 10 times and takes three to four minutes.
The sustained attention test run on MATLAB (R2017b, 64-bit) software using the Psychtoolbox-3 plug-in is run on a touchscreen LCD monitor.
A minimum of 0 and a maximum of 10 points are obtained from each stage of the test, and an increase in the score indicates an increase in the level of sustained attention.
|
First day
|
Stroop Test Çapa Form
Time Frame: First day
|
The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savaş et al.
The test is used to determine the selective attention and reaction time of individuals.
In the test, there are two stimulus cards and a total of 60 items placed on each card in the order of 6 x 10.
The first card contains small rectangles of red, green and blue, while the second card has color names written in mismatched ink colors.
The Stroop test is one of the most frequently used tests in neuropsychological evaluation.
The fact that it can be applied to people of all age groups in a short time increases the preferability of the test.
|
First day
|
Individual Job Performance Scale
Time Frame: First day
|
The Individual Job Performance Scale is used to measure the performance perception of employees from different occupational groups with or without health problems. It was developed in 2013 by Koopmans et al. The Turkish adaptation of the scale was carried out by Köroğlu Kaba and Öztürk in 2021 and it was determined that it is a reliable and valid measurement tool in the evaluation of nurses' performance perceptions. The Turkish version of the self-report scale consists of 14 items and three sub-dimensions (task performance, contextual performance, counterproductive work behavior). Scoring of the five-point Likert type scale is 1=Rarely, 2=Sometimes, 3=Regular, 4=Frequently, 5=Constantly. A high score from the scale indicates an increase in job performance perception, while a low score indicates a decrease in job performance perception. Items in the counterproductive work behavior sub-dimension are reverse scored. |
First day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chalder Fatigue Scale
Time Frame: At the end of the 1st month
|
The scale was developed by Chalder et al. in 1993 to measure the severity of fatigue perceived by individuals during the last month in clinical and community samples.
The scale, which is self-report and 4-point Likert type, consists of 11 items and two sub-dimensions as physical and mental fatigue.
The physical fatigue subsection score of the scale ranges from 0-21, the mental fatigue subsection score ranges from 0-12, and the total fatigue score ranges from 0-33.
The total fatigue score is obtained by summing the scores of all items.
High scores indicate greater fatigue severity.
|
At the end of the 1st month
|
Computer-Based Sustainable Attention Test
Time Frame: At the end of the 1st month
|
Developed by Haladjian and Pylyshyn in 2006, the test was adapted into Turkish by Ilgaz et al. in 2019.
The test measures the sustained attention levels of individuals; easy, medium, consists of sessions at difficult levels.
The total score that can be obtained from each level varies between 0-10.
Each step of the test is repeated 10 times and takes three to four minutes.
The sustained attention test run on MATLAB (R2017b, 64-bit) software using the Psychtoolbox-3 plug-in is run on a touchscreen LCD monitor.
A minimum of 0 and a maximum of 10 points are obtained from each stage of the test, and an increase in the score indicates an increase in the level of sustained attention.
|
At the end of the 1st month
|
Stroop Test Çapa Form
Time Frame: At the end of the 1st month
|
The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savaş et al.
The test is used to determine the selective attention and reaction time of individuals.
In the test, there are two stimulus cards and a total of 60 items placed on each card in the order of 6 x 10.
The first card contains small rectangles of red, green and blue, while the second card has color names written in mismatched ink colors.
The Stroop test is one of the most frequently used tests in neuropsychological evaluation.
The fact that it can be applied to people of all age groups in a short time increases the preferability of the test.
|
At the end of the 1st month
|
Individual Job Performance Scale
Time Frame: At the end of the 1st month
|
The Individual Job Performance Scale is used to measure the performance perception of employees from different occupational groups with or without health problems. It was developed in 2013 by Koopmans et al. The Turkish adaptation of the scale was carried out by Köroğlu Kaba and Öztürk in 2021 and it was determined that it is a reliable and valid measurement tool in the evaluation of nurses' performance perceptions. The Turkish version of the self-report scale consists of 14 items and three sub-dimensions (task performance, contextual performance, counterproductive work behavior). Scoring of the five-point Likert type scale is 1=Rarely, 2=Sometimes, 3=Regular, 4=Frequently, 5=Constantly. A high score from the scale indicates an increase in job performance perception, while a low score indicates a decrease in job performance perception. Items in the counterproductive work behavior sub-dimension are reverse scored. |
At the end of the 1st month
|
Chalder Fatigue Scale
Time Frame: At the end of the 2st month
|
The scale was developed by Chalder et al. in 1993 to measure the severity of fatigue perceived by individuals during the last month in clinical and community samples.
The scale, which is self-report and 4-point Likert type, consists of 11 items and two sub-dimensions as physical and mental fatigue.
The physical fatigue subsection score of the scale ranges from 0-21, the mental fatigue subsection score ranges from 0-12, and the total fatigue score ranges from 0-33.
The total fatigue score is obtained by summing the scores of all items.
High scores indicate greater fatigue severity.
|
At the end of the 2st month
|
Computer-Based Sustainable Attention Test
Time Frame: At the end of the 2st month
|
Developed by Haladjian and Pylyshyn in 2006, the test was adapted into Turkish by Ilgaz et al. in 2019.
The test measures the sustained attention levels of individuals; easy, medium, consists of sessions at difficult levels.
The total score that can be obtained from each level varies between 0-10.
Each step of the test is repeated 10 times and takes three to four minutes.
The sustained attention test run on MATLAB (R2017b, 64-bit) software using the Psychtoolbox-3 plug-in is run on a touchscreen LCD monitor.
A minimum of 0 and a maximum of 10 points are obtained from each stage of the test, and an increase in the score indicates an increase in the level of sustained attention.
|
At the end of the 2st month
|
Stroop Test Çapa Form
Time Frame: At the end of the 2st month
|
The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savaş et al.
The test is used to determine the selective attention and reaction time of individuals.
In the test, there are two stimulus cards and a total of 60 items placed on each card in the order of 6 x 10.
The first card contains small rectangles of red, green and blue, while the second card has color names written in mismatched ink colors.
The Stroop test is one of the most frequently used tests in neuropsychological evaluation.
The fact that it can be applied to people of all age groups in a short time increases the preferability of the test.
|
At the end of the 2st month
|
Individual Job Performance Scale
Time Frame: At the end of the 2st month
|
The Individual Job Performance Scale is used to measure the performance perception of employees from different occupational groups with or without health problems. It was developed in 2013 by Koopmans et al. The Turkish adaptation of the scale was carried out by Köroğlu Kaba and Öztürk in 2021 and it was determined that it is a reliable and valid measurement tool in the evaluation of nurses' performance perceptions. The Turkish version of the self-report scale consists of 14 items and three sub-dimensions (task performance, contextual performance, counterproductive work behavior). Scoring of the five-point Likert type scale is 1=Rarely, 2=Sometimes, 3=Regular, 4=Frequently, 5=Constantly. A high score from the scale indicates an increase in job performance perception, while a low score indicates a decrease in job performance perception. Items in the counterproductive work behavior sub-dimension are reverse scored. |
At the end of the 2st month
|
Chalder Fatigue Scale
Time Frame: At the end of the 3st month
|
The scale was developed by Chalder et al. in 1993 to measure the severity of fatigue perceived by individuals during the last month in clinical and community samples.
The scale, which is self-report and 4-point Likert type, consists of 11 items and two sub-dimensions as physical and mental fatigue.
The physical fatigue subsection score of the scale ranges from 0-21, the mental fatigue subsection score ranges from 0-12, and the total fatigue score ranges from 0-33.
The total fatigue score is obtained by summing the scores of all items.
High scores indicate greater fatigue severity.
|
At the end of the 3st month
|
Computer-Based Sustainable Attention Test
Time Frame: At the end of the 3st month
|
Developed by Haladjian and Pylyshyn in 2006, the test was adapted into Turkish by Ilgaz et al. in 2019.
The test measures the sustained attention levels of individuals; easy, medium, consists of sessions at difficult levels.
The total score that can be obtained from each level varies between 0-10.
Each step of the test is repeated 10 times and takes three to four minutes.
The sustained attention test run on MATLAB (R2017b, 64-bit) software using the Psychtoolbox-3 plug-in is run on a touchscreen LCD monitor.
A minimum of 0 and a maximum of 10 points are obtained from each stage of the test, and an increase in the score indicates an increase in the level of sustained attention.
|
At the end of the 3st month
|
Stroop Test Çapa Form
Time Frame: At the end of the 3st month
|
The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savaş et al.
The test is used to determine the selective attention and reaction time of individuals.
In the test, there are two stimulus cards and a total of 60 items placed on each card in the order of 6 x 10.
The first card contains small rectangles of red, green and blue, while the second card has color names written in mismatched ink colors.
The Stroop test is one of the most frequently used tests in neuropsychological evaluation.
The fact that it can be applied to people of all age groups in a short time increases the preferability of the test.
|
At the end of the 3st month
|
Individual Job Performance Scale
Time Frame: At the end of the 3st month
|
The Individual Job Performance Scale is used to measure the performance perception of employees from different occupational groups with or without health problems. It was developed in 2013 by Koopmans et al. The Turkish adaptation of the scale was carried out by Köroğlu Kaba and Öztürk in 2021 and it was determined that it is a reliable and valid measurement tool in the evaluation of nurses' performance perceptions. The Turkish version of the self-report scale consists of 14 items and three sub-dimensions (task performance, contextual performance, counterproductive work behavior). Scoring of the five-point Likert type scale is 1=Rarely, 2=Sometimes, 3=Regular, 4=Frequently, 5=Constantly. A high score from the scale indicates an increase in job performance perception, while a low score indicates a decrease in job performance perception. Items in the counterproductive work behavior sub-dimension are reverse scored. |
At the end of the 3st month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NKOROGLUKABA-TEZ-KTÜ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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