- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06382090
Premenstrual Syndrome and Laughter Yoga
The Effect of Laughter Yoga on Premenstrual Syndrome in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laughter yoga
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.
|
This practice, which includes deep breathing exercises and laughter exercises, takes approximately 45 minutes.
The sessions will be conducted by the principal investigator.
|
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PamukkaleU-SBE-BB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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