Premenstrual SyndromeNCT06382090
Premenstrual Syndrome and Laughter Yoga
A study testing Laughter yoga in people with Premenstrual Syndrome and Laughter, run by Pamukkale University.
Trial summary
In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Laughter
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2024to 24 May 2025
- 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 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Agreeing to participate in the research
- Having a regular menstrual cycle (menstruation every 21-35 days and without complaints of intermittent bleeding) for the last 6 months
- Not receiving medical treatment for PMS
Who cannot join
- Not agreeing to participate in the research
- Having had any surgical operation in the last 3 months
- Presence of a chronic disease (asthma, DM, etc.)
- Presence of gynecological disease
- Using hormonal contraception (such as oral contraceptives and injections).
About this study
Official title: The Effect of Laughter Yoga on Premenstrual Syndrome in Adolescents
In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined.
Read the detailed description
According to the Nursing Interventions Classification (NIC), laughter therapy, one of the interventions used in nursing care, appears as a universal approach. Laughter therapy is defined as facilitating the patient's perception, appreciation, and expression of what is funny, entertaining, or ridiculous in order to build relationships, reduce tension, release anger, facilitate learning, or cope with painful emotions. Laughter therapy, which is applied without using humor, generally includes exercises such as clapping, dancing, and vocalizing laughter-like sounds such as "hoho-hahaha", but it can also include non-laughter elements such as breathing and relaxation exercises. Laughter Yoga is a specific example of non-humorous laughter therapy; It includes yoga exercises such as laughing exercises, clapping, breathing and relaxation exercises. In studies conducted in the pediatric population, laughter yoga has been shown to improve stress, pain, self-esteem , anxiety, hopelessness. Has been found to provide positive improvements in depression and psychological resilience.
The menstrual cycle, which is one of the most important signs of the functioning of the reproductive system, is associated with signs and symptoms that cause physical and psychological problems. Premenstrual Syndrome (PMS) refers to a set of recurrent symptoms that begin at the end of the luteal phase of the menstrual cycle (5-7 days before menstruation) and end in the follicular phase (2-4 days after menstruation). Many women cannot cope with symptoms such as emotional changes, irritability, lack of concentration, depressive mood or insomnia that occur during this period. For this reason, premenstrual symptoms can negatively affect adolescents' participation in classes, school success, social activities and family relationships. In addition to pharmacological agents, non-pharmacological methods such as reflexology, acupuncture, acupressure, cognitive-behavioral approaches and massage therapy have been used in recent years to cope with premenstrual syndrome.
PMS is an important health problem that includes complex symptoms and negatively affects women's quality of life. In order to cope with these symptoms, PMS needs to be addressed multidimensionally. This study aimed to investigate the effect of laughter therapy in coping with premenstrual syndrome.
- Conditions
- Premenstrual Syndrome, Laughter
- Being tested
- Laughter yoga
- Keywords
- Laughter Yoga, Premenstrual Syndrome, Adolescent
- Medical subject headings
- Premenstrual Syndrome, Laughter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
This practice, which includes deep breathing exercises and laughter exercises, takes approximately 45 minutes. The sessions will be conducted by the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga | Experimental | Premenstrual syndrome scale will be applied to adolescents as a pre-test. 34 randomly selected students who pass the cutoff score on this scale will form the experimental group. A total of 10 sessions of laughter yoga will be performed for this group, twice a week for 5 weeks. At the end of the tenth session, the premenstrual syndrome scale will be re-applied to the experimental group as a post-test. Receives: Other: Laughter yoga |
| Control | No intervention | Premenstrual syndrome scale will be applied to adolescents as a pre-test. 34 randomly selected students who pass the cutoff score on this scale will form the control group. No intervention will be applied to this group. At the end of five weeks, the premenstrual syndrome scale will be applied again to the control group as a post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Symptom Scale
Premenstrual Syndrome Scale is a five-point Likert type scale with 44 items. In the application of PMSS, as stated in the instruction at the beginning, after reading the item, marking is made according to whether this situation is "one week before menstruation", taking into account the degrees to the right of the relevant item. In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option is evaluated as 2 points, the "Sometimes" option is evaluated as 3 points, the "Often" option is evaluated as 4 points and the "Always" option is evaluated as 5 points. The scale has a total of nine subscales: Depressive Affect, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes and Bloating. The higher the score, the more intense the premenstrual syndrome symptoms are considered.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start26 Apr 2024 (estimated)
- Primary completion24 May 2024 (estimated)
- Study completion24 May 2025 (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 Pamukkale 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
- Two groups: comparative experiment and control
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Bakırlıoğlu, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382090
- Sponsor's protocol ID
- PamukkaleU-SBE-BB-01
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Premenstrual Syndrome in Adolescents
- ClinicalTrials.gov ID
- NCT06382090
- Acronym / sponsor ID
- PamukkaleU-SBE-BB-01
- Conditions
- Premenstrual Syndrome, Laughter
- Keywords
- Laughter Yoga, Premenstrual Syndrome, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 26 Apr 2024 (estimated)
- Primary completion
- 24 May 2024 (estimated)
- Study completion
- 24 May 2025 (estimated)
- First posted
- 24 Apr 2024 (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.
In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined.
Detailed description
According to the Nursing Interventions Classification (NIC), laughter therapy, one of the interventions used in nursing care, appears as a universal approach. Laughter therapy is defined as facilitating the patient's perception, appreciation, and expression of what is funny, entertaining, or ridiculous in order to build relationships, reduce tension, release anger, facilitate learning, or cope with painful emotions. Laughter therapy, which is applied without using humor, generally includes exercises such as clapping, dancing, and vocalizing laughter-like sounds such as "hoho-hahaha", but it can also include non-laughter elements such as breathing and relaxation exercises. Laughter Yoga is a specific example of non-humorous laughter therapy; It includes yoga exercises such as laughing exercises, clapping, breathing and relaxation exercises. In studies conducted in the pediatric population, laughter yoga has been shown to improve stress, pain, self-esteem , anxiety, hopelessness. Has been found to provide positive improvements in depression and psychological resilience.
The menstrual cycle, which is one of the most important signs of the functioning of the reproductive system, is associated with signs and symptoms that cause physical and psychological problems. Premenstrual Syndrome (PMS) refers to a set of recurrent symptoms that begin at the end of the luteal phase of the menstrual cycle (5-7 days before menstruation) and end in the follicular phase (2-4 days after menstruation). Many women cannot cope with symptoms such as emotional changes, irritability, lack of concentration, depressive mood or insomnia that occur during this period. For this reason, premenstrual symptoms can negatively affect adolescents' participation in classes, school success, social activities and family relationships. In addition to pharmacological agents, non-pharmacological methods such as reflexology, acupuncture, acupressure, cognitive-behavioral approaches and massage therapy have been used in recent years to cope with premenstrual syndrome.
PMS is an important health problem that includes complex symptoms and negatively affects women's quality of life. In order to cope with these symptoms, PMS needs to be addressed multidimensionally. This study aimed to investigate the effect of laughter therapy in coping with premenstrual syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: comparative experiment and control
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga | Experimental | Other: Laughter yogaPremenstrual syndrome scale will be applied to adolescents as a pre-test. 34 randomly selected students who pass the cutoff score on this scale will form the experimental group. A total of 10 sessions of laughter yoga will be performed for this group, twice a week for 5 weeks. At the end of the tenth session, the premenstrual syndrome scale will be re-applied to the experimental group as a post-test. |
| Control | No intervention | –Premenstrual syndrome scale will be applied to adolescents as a pre-test. 34 randomly selected students who pass the cutoff score on this scale will form the control group. No intervention will be applied to this group. At the end of five weeks, the premenstrual syndrome scale will be applied again to the control group as a post-test. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Agreeing to participate in the research
- Having a regular menstrual cycle (menstruation every 21-35 days and without complaints of intermittent bleeding) for the last 6 months
- Not receiving medical treatment for PMS
Key exclusion criteria (5 listed)
- Not agreeing to participate in the research
- Having had any surgical operation in the last 3 months
- Presence of a chronic disease (asthma, DM, etc.)
- Presence of gynecological disease
- Using hormonal contraception (such as oral contraceptives and injections).
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 yogaThis practice, which includes deep breathing exercises and laughter exercises, takes approximately 45 minutes. The sessions will be conducted by the principal investigator. | Other | Laughter yoga |
Primary outcome
Premenstrual Symptom Scale
Time frame: 5 weeks
Premenstrual Syndrome Scale is a five-point Likert type scale with 44 items. In the application of PMSS, as stated in the instruction at the beginning, after reading the item, marking is made according to whether this situation is "one week before menstruation", taking into account the degrees to the right of the relevant item. In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option is evaluated as 2 points, the "Sometimes" option is evaluated as 3 points, the "Often" option is evaluated as 4 points and the "Always" option is evaluated as 5 points. The scale has a total of nine subscales: Depressive Affect, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes and Bloating. The higher the score, the more intense the premenstrual syndrome symptoms are considered.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga in people with Premenstrual Syndrome and Laughter, run by Pamukkale 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 3 inclusion and 5 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 24 Apr 2024. 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?
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?
Premenstrual Symptom Scale (time frame: 5 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 Apr 2024.