- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634343
Laughter Therapy and Mindfulness Practices
August 20, 2024 updated by: Nagihan Koroglu Kaba
Laughter Therapy and Mindfulness Practices in Nurses
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 effects of both applications on fatigue, attention and performance will be investigated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bayburt, Turkey
- Bayburt University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- at least 6 months experience
- volunteering
- alternative work schedule
Exclusion Criteria:
- Not being a nurse,
- Pregnancy
- Diagnosis of colour blindness, cardiovascular, psychological diseases
- Meditating before
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
No Intervention: Control Group
No intervention was made in the control group.
|
|
|
Experimental: experimental group 1
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, is used to relieve pain and stress and to promote a general sense of well-being.
Laughter therapy is simply a method of 'laughing for no reason' in which the person interacts in a group setting with improvisation or pantomime-like exercises and childish games without humour, jokes or funny events.
The aim is thus to benefit from laughter.
|
|
Experimental: experimental group 2
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
Personal Information Form
Time Frame: First day
|
This form developed by the researcher consists of six questions about the characteristics of nurses.
|
First day
|
|
Chalder Fatigue Scale
Time Frame: First day
|
The scale was developed in 1993 to measure the severity of fatigue.
The scale has two sub-dimensions (physical and mental) and consists of 11 items.
The total fatigue score is obtained by summing the scores of all items.
Higher scores indicate greater severity of fatigue.
|
First day
|
|
Computer-Based Sustainable Attention Test
Time Frame: First day
|
Developed in 2006, the test measures sustained attention at three levels: easy, medium and difficult.
A minimum of 0 and a maximum of 10 are taken from each level.
An increase in the test score indicates an increase in the level of sustained attention.
|
First day
|
|
Individual Job Performance Scale
Time Frame: First day
|
The scale developed by Koopmans et al. in 2013 measures employee performance in three dimensions (task, contextual, counterproductive behaviour).
The scale has 14 items and is a five-point Likert scale.
|
First day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
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
|
|
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
|
|
Chalder Fatigue Scale
Time Frame: At the end of the 1st month
|
The scale was developed in 1993 to measure the severity of fatigue.
The scale has two sub-dimensions (physical and mental) and consists of 11 items.
The total fatigue score is obtained by summing the scores of all items.
Higher scores indicate greater severity of fatigue.
|
At the end of the 1st month
|
|
Computer-Based Sustainable Attention Test
Time Frame: At the end of the 1st month
|
Developed in 2006, the test measures sustained attention at three levels: easy, medium and difficult.
A minimum of 0 and a maximum of 10 are taken from each level.
An increase in the test score indicates an increase in the level of sustained attention.
|
At the end of the 1st month
|
|
Individual Job Performance Scale
Time Frame: At the end of the 1st month
|
The scale developed by Koopmans et al. in 2013 measures employee performance in three dimensions (task, contextual, counterproductive behaviour).
The scale has 14 items and is a five-point Likert scale.
|
At the end of the 1st month
|
|
Chalder Fatigue Scale
Time Frame: At the end of the 2st month
|
The scale was developed in 1993 to measure the severity of fatigue.
The scale has two sub-dimensions (physical and mental) and consists of 11 items.
The total fatigue score is obtained by summing the scores of all items.
Higher scores indicate greater severity of fatigue.
|
At the end of the 2st month
|
|
Computer-Based Sustainable Attention Test
Time Frame: At the end of the 2st month
|
Developed in 2006, the test measures sustained attention at three levels: easy, medium and difficult.
A minimum of 0 and a maximum of 10 are taken from each level.
An increase in the test score indicates an increase in the level of sustained attention.
|
At the end of the 2st month
|
|
Individual Job Performance Scale
Time Frame: At the end of the 2st month
|
The scale developed by Koopmans et al. in 2013 measures employee performance in three dimensions (task, contextual, counterproductive behaviour).
The scale has 14 items and is a five-point Likert scale.
|
At the end of the 2st month
|
|
Chalder Fatigue Scale
Time Frame: At the end of the 3st month
|
The scale was developed in 1993 to measure the severity of fatigue.
The scale has two sub-dimensions (physical and mental) and consists of 11 items.
The total fatigue score is obtained by summing the scores of all items.
Higher scores indicate greater severity of fatigue.
|
At the end of the 3st month
|
|
Computer-Based Sustainable Attention Test
Time Frame: At the end of the 3st month
|
Developed in 2006, the test measures sustained attention at three levels: easy, medium and difficult.
A minimum of 0 and a maximum of 10 are taken from each level.
An increase in the test score indicates an increase in the level of sustained attention.
|
At the end of the 3st month
|
|
Individual Job Performance Scale
Time Frame: At the end of the 3st month
|
The scale developed by Koopmans et al. in 2013 measures employee performance in three dimensions (task, contextual, counterproductive behaviour).
The scale has 14 items and is a five-point Likert scale.
|
At the end of the 3st month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2021
Primary Completion (Actual)
April 20, 2022
Study Completion (Actual)
October 20, 2022
Study Registration Dates
First Submitted
November 18, 2022
First Submitted That Met QC Criteria
November 29, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Actual)
August 21, 2024
Last Update Submitted That Met QC Criteria
August 20, 2024
Last Verified
August 1, 2024
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)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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