Nursing CariesNCT03814265
Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol
A study testing Laughter yoga in people with Nursing Caries, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students. This is a randomized controlled study using pre-post-test design with control group. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Laughter yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2017to 20 Dec 2017
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ankara University Faculty of Health Sciences Department of Nursing to be a 1st year student.
Who cannot join
- Diabetes mellitus
- Hypertension
- Hypothyroidism
- Hyperaldosteronism
- Pregnancy
- Malignancy
Show all 12Show fewer
- Congestive heart failure
- Psychotic disorder
- Chronic hepatic failure
- Nephrotic syndrome
- Chronic renal failure diagnosis
- Using medical drug
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.
This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year.
Read the detailed description
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.
This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year. A descriptive question form will apply to the entire population of the research.191 students fulfilling the criteria of this study will be included. Eleven students who have not fullfilled this criteria the inclusion criteria will be excluded from the study. Power analysis has been performed and the required sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of error. Sample of the study consistsof 75 students considering the possibility of students leaving the research. This 75 students will be divided into two groups as intervention group (n=38) and control group (n=37). Intervention and control group have been randomly selected among Ankara University Faculty of Health Sciences Nursing Department.
- Conditions
- Nursing Caries
- Being tested
- Laughter yoga
- Keywords
- Cortisol, Laughter Yoga, Mental Symptom, Nursing, Student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaBehavioural
440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Laughter yoga group Receives: Behavioral: Laughter yoga |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of mental symptoms
Data Collection Form is Brief Symptom Inventory(BSI). There are 5 sub-dimensions and 53 items in total.BSI has 5 sub-dimensions: Anxiety, Hostility, Somatization, Depression, Anxiety. The total score for each subscale is divided by the number of items in that sub-scale. The height of the total scores taken from the scale indicates the frequency of the individual's symptoms. The person answering the scale marks one of the following for each question: (0) None; (1) Very little; (2) "Moderate; (3) quite a lot; (4) Too much Application process consist of three phases such as; pre-test, intervention and post-test. During pre-test phase. Whether there is a significant decrease in posttest scores compared to pre-test mean scores.
Measured: Four weeks
Secondary outcomes (1)
Measurement of saliva cortisol
Saliva samples for the study of salivary cortisol level. Saliva samples have been taken from intervention and control group students for measurement of salivary cortisol level at 07.55 am before each session. During the intervention phase; laughter yoga has been applied to the intervention group after the pre-test. There hasn't been any intervention for the control group during the research.Saliva samples have been taken from the students who have participated in the study at 08.40 am for each cortisol level measurement after each session. According to the Preliminary Test, it will be evaluated whether there is a significant decrease in the final test scores.
Measured: Each session for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start14 Nov 2017
- Primary completion5 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ozlem Ozturk, Ankara University
- Investigators
- Ayfer Tezel, Prof. Dr., Study director, Ankara Uviversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814265
- Sponsor's protocol ID
- LYMSSC26102018
- Status last verified
- Jan 2019
- First submitted
- 22 Nov 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol
- ClinicalTrials.gov ID
- NCT03814265
- Acronym / sponsor ID
- LYMSSC26102018
- Conditions
- Nursing Caries
- Keywords
- Cortisol, Laughter Yoga, Mental Symptom, Nursing, Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 24 Jan 2019 (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.
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.
This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year.
Detailed description
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.
This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year. A descriptive question form will apply to the entire population of the research.191 students fulfilling the criteria of this study will be included. Eleven students who have not fullfilled this criteria the inclusion criteria will be excluded from the study. Power analysis has been performed and the required sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of error. Sample of the study consistsof 75 students considering the possibility of students leaving the research. This 75 students will be divided into two groups as intervention group (n=38) and control group (n=37). Intervention and control group have been randomly selected among Ankara University Faculty of Health Sciences Nursing Department.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Laughter yogaLaughter yoga group |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ankara University Faculty of Health Sciences Department of Nursing to be a 1st year student.
Key exclusion criteria (12 listed)
- Diabetes mellitus
- Hypertension
- Hypothyroidism
- Hyperaldosteronism
- Pregnancy
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 |
|---|---|---|
| Laughter yoga440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh. | Behavioural | Intervention |
Primary outcome
Measurement of mental symptoms
Time frame: Four weeks
Data Collection Form is Brief Symptom Inventory(BSI). There are 5 sub-dimensions and 53 items in total.BSI has 5 sub-dimensions: Anxiety, Hostility, Somatization, Depression, Anxiety. The total score for each subscale is divided by the number of items in that sub-scale. The height of the total scores taken from the scale indicates the frequency of the individual's symptoms. The person answering the scale marks one of the following for each question: (0) None; (1) Very little; (2) "Moderate; (3) quite a lot; (4) Too much Application process consist of three phases such as; pre-test, intervention and post-test. During pre-test phase. Whether there is a significant decrease in posttest scores compared to pre-test mean scores.
1 secondary outcome
Measurement of saliva cortisol
Time frame: Each session for four weeks
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 24 Jan 2019.
- 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.
Ayfer Tezel, Prof. Dr. study director
Ankara Uviversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga in people with Nursing Caries, run by Ankara University 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 1 inclusion and 12 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 24 Jan 2019. 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?
Measurement of mental symptoms (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2019.