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The Effect of Laughter Therapy in Women

Primary Purpose

Migraine, Laughter

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laughter therapy
Sponsored by
Sinop University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Migraine focused on measuring migraine, laughter therapy, young women

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Being a nursing student, Being a female student, Volunteering to participate in the study. Being a woman 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 18 and 30

Sites / Locations

  • Sınop Univercity
  • Sinop üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

experimental group

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

2. Psychological Well-Being Scale:
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).

Full Information

First Posted
March 27, 2023
Last Updated
July 5, 2023
Sponsor
Sinop University
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1. Study Identification

Unique Protocol Identification Number
NCT05804812
Brief Title
The Effect of Laughter Therapy in Women
Official Title
The Effect of Laughter Therapy in Women With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
June 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinop University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.
Detailed Description
The research will be carried out with young girls 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Laughter
Keywords
migraine, laughter therapy, young women

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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 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.
Intervention Type
Behavioral
Intervention Name(s)
laughter therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
1. Personal İnformation form
Description
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.
Time Frame
one day
Secondary Outcome Measure Information:
Title
2. Psychological Well-Being Scale:
Description
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).
Time Frame
one day

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being a nursing student, Being a female student, Volunteering to participate in the study. Being a woman 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 18 and 30
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem Erdoğan, PhD
Organizational Affiliation
Sinop University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sınop Univercity
City
Sinop
ZIP/Postal Code
57000
Country
Turkey
Facility Name
Sinop üniversitesi
City
Sinop
ZIP/Postal Code
57000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Laughter Therapy in Women

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