The Effect of Laughter Therapy in Women
1 other identifier
interventional
53
1 country
2
Brief Summary
Migraine: An episodic disorder consisting of severe headache, usually with photophobia (sensitivity to light), phonophobia (sensitivity to sound), and/or nausea (occasionally vomiting). Migraine is predominantly a female disease. The incidence of migraine was found to in women (18.2/1000 person-years) and between the ages of 15-19 in men (6.2/1000 person-years). The incidence of migraine was found to peak between the ages of 20-24 in women (18.2/1000 person-years) and between the ages of 15-19 in men (6.2/1000 person-years). Migraine treatments are generally classified as pharmacological (treatment with medication) and non-pharmacological (treatment with no medication). Laughter therapy has recently come to the fore as a non-pharmacological and alternative treatment in chronic pain management. In a randomized controlled study, 30 minutes of laughter therapy was applied to women on the 2nd and 6th days after mastectomy surgery and it was determined that women who received laughter therapy had a significant decrease in pain and anxiety levels. This study was planned to determine the effect of laughter therapy on women with migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2023
CompletedJuly 7, 2023
March 1, 2023
2 months
March 27, 2023
July 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Personal İnformation form
Personal İnformation form consists of 2 parts. In the first part, the socio-demographic characteristics of the individual, such as class, age, place and region where he lives the longest, mother and father working status, economic status, consist of 9 questions. In the second part, it consists of a total of 9 questions about the characteristics of migraine, including migraine location, frequency, duration of attendance, duration of medication, severity, coping methods, complaints associated with migraine, time without medication, and school attendance.
one day
Secondary Outcomes (1)
2. Psychological Well-Being Scale:
one day
Study Arms (2)
control group
NO INTERVENTIONAt the beginning of the study, data collection tools Personal Information Form and Psychological Well-Being Scale will be applied to the control group. No intervention will be made in the control group. Measurement tools will be applied for the post-test.
experimental group
EXPERIMENTALInclusion criteria for the research: Faculty of Health Sciences, to study in the 2022-2023 academic spring semester, to have been diagnosed with migraine, to be young and to volunteer to participate in the research. Exclusion criteria from the study; Not studying at the Faculty of Health Sciences and not volunteering to participate in the research. The application and control group will be determined on random.org among the group that constitutes the sample of the study. Laughter therapy sessions will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. At the end of two months, the Personal Information Form and Psychological Well-Being Scale will be administered again to both the application group and the control group.
Interventions
Assigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out.
Eligibility Criteria
You may qualify if:
- Being a nursing student,
- Being a female student,
- Volunteering to participate in the study.
- Being a woman
- Being diagnosed with migraine
You may not qualify if:
- Not to study as a nursing student
- Being a male student
- Not to volunteer to participate in the study
- Not being a woman between the ages of 18 and 30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sinop Universitylead
Study Sites (2)
Sinop üniversitesi
Sinop, 57000, Turkey (Türkiye)
Sınop Univercity
Sinop, 57000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meryem Erdoğan, PhD
Sinop University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
April 6, 2023
Primary Completion
May 25, 2023
Study Completion
June 28, 2023
Last Updated
July 7, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share