Laughter YogaNCT04175652
Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality
A study testing Laughter yoga in people with Laughter Yoga and Hemodialysis Patients, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga, Hemodialysis Patients
- 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
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2017to 31 Oct 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- receiving treatment in a dialysis center
- must be between 18 and 80 years old and willing to participate in the study
- receiving HD treatment at least twice a week for a month or longer
- having a pain level and above
- level of 5 above according to the Pittsburgh Sleep Quality Index.
Who cannot join
- not taking any medicine for sleeping disorder
- not having any visual, hearing or communication impairments
- not having any mental disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Istanbul, Küçükçekmece, 34303
About this study
Official title: Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality: A Randomized Controlled Trial
This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality.
Read the detailed description
While there are studies conducted with laughter yoga on different patient groups in Turkey, no studies have been found on hemodialysis patients specifically. For this reason, it was thought that studies are needed which will prove the effect of laughter yoga practices on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.
- Conditions
- Laughter Yoga, Hemodialysis Patients
- Being tested
- Laughter yoga
- Keywords
- Laughter Yoga, Hemodialysis, Pain, Sleep, Beta Endorphin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaBehavioural
The laughter yoga practice was initiated through clapping and warm-up exercises: hands were clapped keeping hands in parallel with each other and ensuring that the fingertips touched each other. To increase the energy level of the group, a rhythmic beat was added to the clapping in the form of 1-2, 1-2-3. While this was being sung a rhythm was tapped out on the floor by moving the feet up and down. Eye contact was constantly maintained with the participants. In the second phase, deep breathing exercises were performed. Participants were encouraged to inhale from the diaphragm. Individuals were asked to put their hands on their belly and inhale through the nose and then slowly exhale through the mouth. After the deep breathing exercise, the participants were encouraged to laugh through playing children's games in the third phase.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga group, group doing laughter yoga | Experimental | The duration of the laughter yoga was 30 minutes and a total of 16 sessions were performed on a twice-weekly basis. Receives: Behavioral: Laughter yoga |
| No laughter yoga group, group not doing laughter yoga | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-endorphin Level
Blood samples were taken from all individuals who participated in the study, through their AVF fistulas by using 3.5 mL gel-based tubes and following antiseptic rules. Blood samples which were fully coagulated were centrifuged at 1500xg for 10 minutes and serums were obtained. The serum samples were separated into portions and kept at -80 °C until the analysis.
Measured: 8 week
Visual Analog Scale
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Measured: 8 week
Pittsburgh Sleep Quality Index
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start15 Nov 2017
- Primary completion15 Jun 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laughter YogaStudies 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
- Parallel Assignment Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz Ozer, Dr, Principal investigator, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175652
- Sponsor's protocol ID
- 2017-314
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after the article is published
Publications
Heo EH, Kim S, Park HJ, Kil SY. The effects of a simulated laughter programme on mood, cortisol levels, and health-related quality of life among haemodialysis patients. Complement Ther Clin Pract. 2016 Nov;25:1-7. doi: 10.1016/j.ctcp.2016.07.001. Epub 2016 Jul 27.
PubMed 27863598Yim J. Therapeutic Benefits of Laughter in Mental Health: A Theoretical Review. Tohoku J Exp Med. 2016 Jul;239(3):243-9. doi: 10.1620/tjem.239.243.
PubMed 27439375
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04175652
- Acronym / sponsor ID
- 2017-314
- Conditions
- Laughter Yoga, Hemodialysis Patients
- Keywords
- Laughter Yoga, Hemodialysis, Pain, Sleep, Beta Endorphin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 25 Nov 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.
This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality.
Detailed description
While there are studies conducted with laughter yoga on different patient groups in Turkey, no studies have been found on hemodialysis patients specifically. For this reason, it was thought that studies are needed which will prove the effect of laughter yoga practices on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga group, group doing laughter yoga | Experimental | Behavioral: Laughter yogaThe duration of the laughter yoga was 30 minutes and a total of 16 sessions were performed on a twice-weekly basis. |
| No laughter yoga group, group not doing laughter yoga | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- receiving treatment in a dialysis center
- must be between 18 and 80 years old and willing to participate in the study
- receiving HD treatment at least twice a week for a month or longer
- having a pain level and above
- level of 5 above according to the Pittsburgh Sleep Quality Index.
Key exclusion criteria (3 listed)
- not taking any medicine for sleeping disorder
- not having any visual, hearing or communication impairments
- not having any mental disorders
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 yogaThe laughter yoga practice was initiated through clapping and warm-up exercises: hands were clapped keeping hands in parallel with each other and ensuring that the fingertips touched each other. To increase the energy level of the group, a rhythmic beat was added to the clapping in the form of 1-2, 1-2-3. While this was being sung a rhythm was tapped out on the floor by moving the feet up and down. Eye contact was constantly maintained with the participants. In the second phase, deep breathing exercises were performed. Participants were encouraged to inhale from the diaphragm. Individuals were asked to put their hands on their belly and inhale through the nose and then slowly exhale through the mouth. After the deep breathing exercise, the participants were encouraged to laugh through playing children's games in the third phase. | Behavioural | Laughter yoga group, group doing laughter yoga |
Primary outcome
Beta-endorphin Level
Time frame: 8 week
Blood samples were taken from all individuals who participated in the study, through their AVF fistulas by using 3.5 mL gel-based tubes and following antiseptic rules. Blood samples which were fully coagulated were centrifuged at 1500xg for 10 minutes and serums were obtained. The serum samples were separated into portions and kept at -80 °C until the analysis.
Visual Analog Scale
Time frame: 8 week
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Pittsburgh Sleep Quality Index
Time frame: 8 week
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
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 25 Nov 2019.
- Background: PubMed 27863598Heo EH, Kim S, Park HJ, Kil SY. The effects of a simulated laughter programme on mood, cortisol levels, and health-related quality of life among haemodialysis patients. Complement Ther Clin Pract. 2016 Nov;25:1-7. doi: 10.1016/j.ctcp.2016.07.001. Epub 2016 Jul 27.
- Background: PubMed 27439375Yim J. Therapeutic Benefits of Laughter in Mental Health: A Theoretical Review. Tohoku J Exp Med. 2016 Jul;239(3):243-9. doi: 10.1620/tjem.239.243.
- Individual participant dataSharing planned: No. after the article is published
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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.
Zülfünaz Ozer, Dr principal investigator
Istanbul Sabahattin Zaim University
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 Laughter Yoga and Hemodialysis Patients, run by Istanbul Sabahattin Zaim 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 5 inclusion and 3 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 25 Nov 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?
Beta-endorphin Level (time frame: 8 week). The study lists 3 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 NCT04175652, which also lists 2 linked publications.
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 25 Nov 2019.