LaughterNCT05806541
The Effect Of Laughter Therapy On Self-Efficacy
A study testing laughter therapy in people with Laughter and Self Efficacy, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: Laughter is an innate, universal response we give to events in our lives. "Laughter Therapy" is a technique created by combining breathing techniques and laughter and takes its place in complementary medicine. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter, Self Efficacy
- What is being tested?
- laughter therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2023to 8 Jan 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study as a nursing student at the Faculty of Health Sciences where the study will be conducted,
- Being a nursing first class student,
- Volunteering to participate in the study.
- Absence of any psychological disorder
Who cannot join
- Not to study as a nursing student at the Faculty of Health Sciences where the study will be conducted,
- Not to comply with the criteria for inclusion in the study and
- Not to volunteer to participate in the study.
- Have any psychological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Laughter Therapy On Self-Efficacy And Psychological Well-Being İn Nursing Students
Brief Summary: Laughter is an innate, universal response we give to events in our lives. "Laughter Therapy" is a technique created by combining breathing techniques and laughter and takes its place in complementary medicine. It is a simulation performed by making eye contact with the members of the group, in which physical exercise and childlike games take place. Laughter sessions are about 30-40 minutes. continues and this simulation in a short time creates a real and contagious laugh. It has been determined by studies that laughter therapy physiologically increases breathing and relaxes muscles, strengthens mental function by decreasing the level of stress hormones, reduces burnout, depression and anxiety levels, positively affects quality of life, increases social interaction and provides psychological well-being.
Self-efficacy, on the other hand, is a state that expresses a person's belief that he or she is able to perform a certain task. More broadly, self-efficacy examines an individual's ability to perform a task rather than individual characteristics such as physical or psychological characteristics. Psychological well-being is as important as self-efficacy in the development of students. In addition, studies on mental health have generally focused on anxiety and depression. Most of these studies were related to well-being and contributed to the literature. Psychological well-being is defined as managing existential challenges in life.
Aim: This study was planned to determine the Effect of Laughter Therapy on Self-Efficacy and Psychological Well-Being in Nursing Students.
Read the detailed description
Method: This study will be carried out with 3rd and 4th year students studying at Sinop University, Faculty of Health Sciences, Department of Nursing. It is aimed to include all first-year nursing students in the study. The study will be carried out in the autumn semester of the 2023-2024 academic year. The sample of the study will be all young women studying at the Faculty of Health Sciences, meeting the inclusion criteria and agreeing to participate in the study.
Arm Title: Control Group At the beginning of the study, data collection tools Personal Information Form, Academic Self-Efficacy Scale 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 Personal Information Form, Academic Self-Efficacy Scale and Psychological Well-Being Scale will be applied to all 4th year nursing students studying at Sinop University Health Sciences in the autumn term of 2023-2024.
- Conditions
- Laughter, Self Efficacy
- Being tested
- laughter therapy
- Keywords
- laughter therapy, self efficacy, nursing student, well being
- Medical subject headings
- Laughter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | At the beginning of the study, data collection tools Personal Information Form, Academic Self-Efficacy Scale 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 | Experimental | Arm: Experimental: experimental group Personal Information Form, Academic Self-Efficacy Scale and Psychological Well-Being Scale will be applied to all 4th year nursing students studying at Sinop University Health Sciences in the autumn term of 2023-2024.
Laughter therapy session will be applied face to face for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. Psychological Well-Being Scale and Academic Self-Efficacy Scale will be applied again after the application and in the follow-up (after the application is over). Receives: Behavioral: laughter therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
This form consists of questions such as age, gender, distraction, loss of interest in lessons, eating problems, sleep status, stress, anxiety, fear, social media use.
Measured: one day
Secondary outcomes (1)
Academic Self-Efficacy Scale
The Academic Self-Efficacy Scale (ASES) was developed by Bulfone et al. in 2019 as 14 items and four sub-dimensions to determine the academic self-efficacy of undergraduate nursing students. Sub-dimensions of the scale 1- Intrinsic Emotion Management (items 1, 2, 3) from 3 items, 2-Automatically Controlled Behavior (items 4, 5, 6, 7) consisting of 4 items, 3-External Emotion Management (8, 9, 10) 4-Socialism (items 11, 12, 13) consists of 5 items. The items of this scale are scored with a 5-point Likert type (1=I don't trust myself at all, 5=I have a lot of confidence in myself) in response to the question "How much do you trust yourself". The score of each question varies between 1-5 and consists of positive items. The Cronbach Alpha value of the scale was obtained as 0.84.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start5 Nov 2023
- Primary completion5 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaughterStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasemin Özyer, PhD, Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806541
- Sponsor's protocol ID
- sinopUyasemin-1
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2023
- Last updated
- 1 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Laughter Therapy On Self-Efficacy And Psychological Well-Being İn Nursing Students
- ClinicalTrials.gov ID
- NCT05806541
- Acronym / sponsor ID
- sinopUyasemin-1
- Conditions
- Laughter, Self Efficacy
- Keywords
- laughter therapy, self efficacy, nursing student, well being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 10 Apr 2023 (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.
Brief Summary: Laughter is an innate, universal response we give to events in our lives. "Laughter Therapy" is a technique created by combining breathing techniques and laughter and takes its place in complementary medicine. It is a simulation performed by making eye contact with the members of the group, in which physical exercise and childlike games take place. Laughter sessions are about 30-40 minutes. continues and this simulation in a short time creates a real and contagious laugh. It has been determined by studies that laughter therapy physiologically increases breathing and relaxes muscles, strengthens mental function by decreasing the level of stress hormones, reduces burnout, depression and anxiety levels, positively affects quality of life, increases social interaction and provides psychological well-being.
Self-efficacy, on the other hand, is a state that expresses a person's belief that he or she is able to perform a certain task. More broadly, self-efficacy examines an individual's ability to perform a task rather than individual characteristics such as physical or psychological characteristics. Psychological well-being is as important as self-efficacy in the development of students. In addition, studies on mental health have generally focused on anxiety and depression. Most of these studies were related to well-being and contributed to the literature. Psychological well-being is defined as managing existential challenges in life.
Aim: This study was planned to determine the Effect of Laughter Therapy on Self-Efficacy and Psychological Well-Being in Nursing Students.
Detailed description
Method: This study will be carried out with 3rd and 4th year students studying at Sinop University, Faculty of Health Sciences, Department of Nursing. It is aimed to include all first-year nursing students in the study. The study will be carried out in the autumn semester of the 2023-2024 academic year. The sample of the study will be all young women studying at the Faculty of Health Sciences, meeting the inclusion criteria and agreeing to participate in the study.
Arm Title: Control Group At the beginning of the study, data collection tools Personal Information Form, Academic Self-Efficacy Scale 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 Personal Information Form, Academic Self-Efficacy Scale and Psychological Well-Being Scale will be applied to all 4th year nursing students studying at Sinop University Health Sciences in the autumn term of 2023-2024.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –At the beginning of the study, data collection tools Personal Information Form, Academic Self-Efficacy Scale 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 | Experimental | Behavioral: laughter therapyArm: Experimental: experimental group Personal Information Form, Academic Self-Efficacy Scale and Psychological Well-Being Scale will be applied to all 4th year nursing students studying at Sinop University Health Sciences in the autumn term of 2023-2024. Laughter therapy session will be applied face to face for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. Psychological Well-Being Scale and Academic Self-Efficacy Scale will be applied again after the application and in the follow-up (after the application is over). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Study as a nursing student at the Faculty of Health Sciences where the study will be conducted,
- Being a nursing first class student,
- Volunteering to participate in the study.
- Absence of any psychological disorder
Key exclusion criteria (4 listed)
- Not to study as a nursing student at the Faculty of Health Sciences where the study will be conducted,
- Not to comply with the criteria for inclusion in the study and
- Not to volunteer to participate in the study.
- Have any psychological problems
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 therapyLaughter 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. | Behavioural | experimental group |
Primary outcome
Introductory Information Form
Time frame: one day
This form consists of questions such as age, gender, distraction, loss of interest in lessons, eating problems, sleep status, stress, anxiety, fear, social media use.
1 secondary outcome
Academic Self-Efficacy Scale
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Laughter
Enrolling by invitation
Humor-Based Video Intervention on Preoperative Anxiety Veya Humor Video and Recovery in Cholecystectomy
Preoperative Anxiety, Laparoscopic Cholecystectomy
Not yet recruiting
The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers
Burnout, Professional, Stress, Psychological
Not yet recruiting
Laughter Yoga- Integrated Virtual Reality Nature Exploration in Early Stage of Chemotherapy
Patiens in Early Stage of Chemotherapy
Enrolling by invitation
Effects of Laughter Yoga in the Third Trimester
Pregnancy, Psychosocial Health
Active, not recruiting
Laughter Yoga, Emotional Labor, and Menopause-Specific Quality of Life in Nurses
Menopause, Menopause-Related Quality of Life
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.
Yasemin Özyer, PhD principal investigator
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laughter therapy in people with Laughter and Self Efficacy, run by Sinop University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Introductory Information Form (time frame: one day). 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 1 Apr 2024.