The Effect of Laughter Therapy in Women With Migraine

Sponsor
Sinop University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05804812
Collaborator
(none)
50
2
4.7

Study Details

Study Description

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 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). 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 migraine in women aged 20-24.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: laughter therapy
N/A

Detailed Description

The research will be carried out with young girls between the ages of 20-24 who are studying at the Faculty of Health Sciences of Sinop University in the 2022-2023 academic spring semester. Inclusion 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 girls between the ages of 20-24 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Laughter Therapy in Women With Migraine Between 20-24
Anticipated Study Start Date :
Apr 6, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Aug 28, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

At 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: experimental group

Inclusion 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 girls between the ages of 20-24 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.

Behavioral: laughter therapy
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.

Outcome Measures

Primary Outcome Measures

  1. 1. Personal İnformation form [one day]

    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.

Secondary Outcome Measures

  1. 2. Psychological Well-Being Scale: [one day]

    The Psychological Well-Being Scale was developed by Diener et al. (2009-2010) to measure socio-psychological well-being, complementary to existing well-being measures. The Turkish adaptation of the scale was done by Telef (2011; 2013). It was determined that the item-total correlations of the Psychological Well-Being Scale varied between .41 and .63, and the t-values were significant (p<.001). The items of the Psychological Well-Being Scale are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 24 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being a nursing student,

  • Being a female student,

  • Volunteering to participate in the study.

  • Being a woman between the ages of 20 and 24

  • Being diagnosed with migraine

Exclusion Criteria:
  • 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 20 and 24

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sinop University

Investigators

  • Principal Investigator: Meryem Erdoğan, PhD, Sinop University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sinop University
ClinicalTrials.gov Identifier:
NCT05804812
Other Study ID Numbers:
  • sinopUmeryem-2
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sinop University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023