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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05634343
Other study ID # NKOROGLUKABA-TEZ-KTÜ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2021
Est. completion date October 20, 2022

Study information

Verified date January 2024
Source Bayburt University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nurses working by shifts under intense stress and pressure and using complicated technological products- undergo fatigue and attention deficit with the effect of the many negative factors caused by work setting. This threatens patient and staff safety as well as leads to communicational problems, work absenteeism, lowered motivation, inability to control stress and poor work performance and productivity among nurses as well. In this sense; laughter therapy and mindfulness practices may help nurses cope with these problems because some experimental studies proved that both methods showed many benefits in different samples. However; no studies in which these two methods were compared among nurses were encountered. Therefore; the study -being in experimental design and randomized controlled trial- will be undertaken with a total of 111 nurses employed at a university hospital -37 nurses allocated to the experimental 1 group, 37 nurses to the experimental 2 group and 37 nurses to the control group-. First; Computer-Based Sustained Attention Test, the Stroop Test Çapa Version, The Chalder Fatigue Scale (CFQ) and Individual Work Performance Questionnaire will be administered to the nurses of the experimental and control groups as a pre-test. Then; nurses of the experimental 1 group will join sessions of laughter therapy (30-45 minutes twice a week for 8 weeks) and nurses of the experimental 2 group will join sessions of mindfulness practices (45-60 minutes twice a week for 8 weeks) for two months. One month later when the sessions are started, a mid test will be administered and soon after the sessions are completed a post test will be administered to the nurses via Computer-Based Sustained Attention Test, the Stroop Test Çapa Version, The Chalder Fatigue Scale (CFQ) and Individual Work Performance Questionnaire. One month later after the post test; a follow-up will be performed using the same tools. As a result; the effect of laughter therapy and mindfulness practices upon nurses' fatigue perceptions, attention and work performance levels will be explored.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date October 20, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Laughter Therapy
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.
Mindfulness
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.

Locations

Country Name City State
Turkey Bayburt University Bayburt

Sponsors (2)

Lead Sponsor Collaborator
Nagihan Koroglu Kaba The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personal Information Form 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
Primary Chalder Fatigue Scale 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
Primary Computer-Based Sustainable Attention Test 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
Primary Stroop Test Çapa Form The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savas 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
Primary Individual Job Performance Scale 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 Köroglu 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 Chalder Fatigue Scale 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
Secondary Computer-Based Sustainable Attention Test 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
Secondary Stroop Test Çapa Form The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savas 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
Secondary Individual Job Performance Scale 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 Köroglu 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
Secondary Chalder Fatigue Scale 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
Secondary Computer-Based Sustainable Attention Test 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
Secondary Stroop Test Çapa Form The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savas 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
Secondary Individual Job Performance Scale 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 Köroglu 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
Secondary Chalder Fatigue Scale 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
Secondary Computer-Based Sustainable Attention Test 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
Secondary Stroop Test Çapa Form The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savas 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
Secondary Individual Job Performance Scale 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 Köroglu 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
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