Nurse's RoleNCT05634343
Laughter Therapy and Mindfulness Practices
A study testing experimental group 1 and experimantal group 2 in people with Nurse's Role, run by Nagihan Koroglu Kaba at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- experimental group 1 and experimantal group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at least 6 months experience
- volunteering
- alternative work schedule
Who cannot join
- Not being a nurse,
- Pregnancy
- Diagnosis of colour blindness, cardiovascular, psychological diseases
- Meditating before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nurse's Role
- Being tested
- experimental group 1, experimantal group 2
- Keywords
- Mindfulness, Attention, Laughter therapy, Job performance, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental group 1Other
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.
experimantal group 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group 1 | Experimental | 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. Receives: Other: experimental group 1 |
| experimental group 2 | Experimental | 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. Receives: Other: experimantal group 2 |
| Control Group | No intervention | No intervention was made in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form developed by the researcher consists of six questions about the characteristics of nurses.
Measured: First day
Chalder Fatigue Scale
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.
Measured: First day
Computer-Based Sustainable Attention Test
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.
Measured: First day
Stroop Test Çapa Form
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.
Measured: First day
Individual Job Performance Scale
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.
Measured: First day
Secondary outcomes (12)
Chalder Fatigue Scale
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.
Measured: At the end of the 1st month
Computer-Based Sustainable Attention Test
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.
Measured: At the end of the 1st month
Stroop Test Çapa Form
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.
Measured: At the end of the 1st month
Individual Job Performance Scale
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.
Measured: At the end of the 1st month
Chalder Fatigue Scale
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.
Measured: At the end of the 2st month
Computer-Based Sustainable Attention Test
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.
Measured: At the end of the 2st month
Stroop Test Çapa Form
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.
Measured: At the end of the 2st month
Individual Job Performance Scale
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.
Measured: At the end of the 2st month
Chalder Fatigue Scale
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.
Measured: At the end of the 3st month
Computer-Based Sustainable Attention Test
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.
Measured: At the end of the 3st month
Stroop Test Çapa Form
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.
Measured: At the end of the 3st month
Individual Job Performance Scale
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.
Measured: At the end of the 3st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start6 Sep 2021
- Primary completion20 Apr 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research examines the effects of laughter and mindfulness on some parameters (fatigue, performance and attention) in nurses.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagihan Koroglu Kaba
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Nagihan Koroglu Kaba, Bayburt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634343
- Sponsor's protocol ID
- NKOROGLUKABA-TEZ-KTÜ
- Status last verified
- Aug 2024
- First submitted
- 18 Nov 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koroglu Kaba N, Ozturk H. The Effects of Laughter Yoga and Mindfulness on Nurses' Fatigue, Work Performance and Attention Levels: A Randomized Controlled Study. Clin Nurse Spec. 2025 Nov-Dec 01;39(6):260-268. doi: 10.1097/NUR.0000000000000927.
PubMed 41118502
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laughter Therapy and Mindfulness Practices in Nurses
- ClinicalTrials.gov ID
- NCT05634343
- Acronym / sponsor ID
- NKOROGLUKABA-TEZ-KTÜ
- Conditions
- Nurse's Role
- Keywords
- Mindfulness, Attention, Laughter therapy, Job performance, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Nagihan Koroglu KabaUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The research examines the effects of laughter and mindfulness on some parameters (fatigue, performance and attention) in nurses.
| Arm | Type | Receives |
|---|---|---|
| experimental group 1 | Experimental | Other: experimental group 1The 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. |
| experimental group 2 | Experimental | Other: experimantal group 2The 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. |
| Control Group | No intervention | –No intervention was made in the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- at least 6 months experience
- volunteering
- alternative work schedule
Key exclusion criteria (4 listed)
- Not being a nurse,
- Pregnancy
- Diagnosis of colour blindness, cardiovascular, psychological diseases
- Meditating before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental group 1Laughter 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. | Other | experimental group 1 |
| experimantal group 2Mindfulness 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. | Other | experimental group 2 |
Primary outcome
Personal Information Form
Time frame: First day
This form developed by the researcher consists of six questions about the characteristics of nurses.
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.
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.
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.
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.
12 secondary outcomes
Chalder Fatigue Scale
Time frame: At the end of the 1st month
Computer-Based Sustainable Attention Test
Time frame: At the end of the 1st month
Stroop Test Çapa Form
Time frame: At the end of the 1st month
Individual Job Performance Scale
Time frame: At the end of the 1st month
Chalder Fatigue Scale
Time frame: At the end of the 2st month
Computer-Based Sustainable Attention Test
Time frame: At the end of the 2st month
Stroop Test Çapa Form
Time frame: At the end of the 2st month
Individual Job Performance Scale
Time frame: At the end of the 2st month
Chalder Fatigue Scale
Time frame: At the end of the 3st month
Computer-Based Sustainable Attention Test
Time frame: At the end of the 3st month
Stroop Test Çapa Form
Time frame: At the end of the 3st month
Individual Job Performance Scale
Time frame: At the end of the 3st month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 41118502Koroglu Kaba N, Ozturk H. The Effects of Laughter Yoga and Mindfulness on Nurses' Fatigue, Work Performance and Attention Levels: A Randomized Controlled Study. Clin Nurse Spec. 2025 Nov-Dec 01;39(6):260-268. doi: 10.1097/NUR.0000000000000927.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group 1 and experimantal group 2 in people with Nurse's Role, run by Nagihan Koroglu Kaba at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: First day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.