Premenstrual SyndromeNCT05859399
The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students
A study testing Laughter yoga in people with Premenstrual Syndrome and Quality of Life, run by Mersin University.
Trial summary
The research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life. Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Quality of Life
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 31 Dec 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To agree to participate in the research,
- To be over 18 years old,
- Not having taken vocational courses
- Not having a chronic disease,
- Having a regular menstrual period,
- Having at least 110 points on the PMS scale
- Not receiving medical treatment for PMS.
Who cannot join
- Refusing to participate in the research,
- To have taken vocational courses,
- Having a chronic illness
- Getting a score lower than 110 on the PMS scale,
- Having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.)
- Receiving medical treatment for PMS.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students With Premenstrual Syndrome
The research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life.
Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. H1: Online laughter yoga has an effect on premenstrual symptoms. H0: Online laughter yoga has no effect on quality of life. H1: Online laughter yoga has an impact on quality of life.
Read the detailed description
59 midwifery students will participate in the research. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.
- Conditions
- Premenstrual Syndrome, Quality of Life
- Being tested
- Laughter yoga
- Keywords
- Premenstrual Syndrome, Quality of life, Laughter yoga, Laughter therapy, Student
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
Also called Laughter therapy
Although the history of laughter yoga dates back to ancient times, its use in medicine has become widespread in the 21st century, while it is used to reduce pain, anxiety, stress, depression and fatigue, it is also a method that can be used to accelerate immunity, quality of life, happiness, sleep quality and recovery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (laughter yoga) group | Experimental | The intervention group will receive 12 online laughter yoga sessions, only one session per week for 12 weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter. Receives: Other: Laughter yoga |
| Control group | No intervention | The control group will receive no intervention for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale (PMSS)
The Premenstrual Syndrome Scale is a five-point Likert type scale consisting of 44 questions that measures the severity of premenstrual symptoms, based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms
Measured: change from baseline, at the end of 12th week of intervention.
Secondary outcomes (1)
World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)
Life of quality will be evaluated by using the WHOQOL-BREF-TR. This scale consists of 27 questions. There are a total of five areas in the scale: physical, mental, social, environmental and national environmental areas. Each area is evaluated within itself. The domain score is calculated with the score it gets from the questions that determine it. Field scores are evaluated between 4-20. Increasing score indicates goodness.
Measured: change from baseline, at the end of 12th week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 May 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahu AKSOY, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859399
- Sponsor's protocol ID
- 001
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT05859399
- Acronym / sponsor ID
- 001
- Conditions
- Premenstrual Syndrome, Quality of Life
- Keywords
- Premenstrual Syndrome, Quality of life, Laughter yoga, Laughter therapy, Student
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 May 2023 (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 research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life.
Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. H1: Online laughter yoga has an effect on premenstrual symptoms. H0: Online laughter yoga has no effect on quality of life. H1: Online laughter yoga has an impact on quality of life.
Detailed description
59 midwifery students will participate in the research. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel, two arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental (laughter yoga) group | Experimental | Other: Laughter yogaThe intervention group will receive 12 online laughter yoga sessions, only one session per week for 12 weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter. |
| Control group | No intervention | –The control group will receive no intervention for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To agree to participate in the research,
- To be over 18 years old,
- Not having taken vocational courses
- Not having a chronic disease,
- Having a regular menstrual period,
Key exclusion criteria (6 listed)
- Refusing to participate in the research,
- To have taken vocational courses,
- Having a chronic illness
- Getting a score lower than 110 on the PMS scale,
- Having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.)
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 yogaAlso: Laughter therapyAlthough the history of laughter yoga dates back to ancient times, its use in medicine has become widespread in the 21st century, while it is used to reduce pain, anxiety, stress, depression and fatigue, it is also a method that can be used to accelerate immunity, quality of life, happiness, sleep quality and recovery. | Other | Experimental (laughter yoga) group |
Primary outcome
Premenstrual Syndrome Scale (PMSS)
Time frame: change from baseline, at the end of 12th week of intervention.
The Premenstrual Syndrome Scale is a five-point Likert type scale consisting of 44 questions that measures the severity of premenstrual symptoms, based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms
1 secondary outcome
World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)
Time frame: change from baseline, at the end of 12th week of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- The effect of online laughter therapy on depression, anxiety, stress, and loneliness among nursing students during the Covid-19 pandemicLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga in people with Premenstrual Syndrome and Quality of Life, run by Mersin University.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahu AKSOY CAN, PhD (05444825892, aksoyahu91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Scale (PMSS) (time frame: change from baseline, at the end of 12th week of intervention.). 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 16 May 2023.