Mental StressTherapyNCT05681013
The Effect of Laughter Therapy on Nursing Students
A study testing Laughter Therapy in people with Mental Stress and Insomnia, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Stress, Insomnia, Sleep Disorder
- 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
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 17 Jun 2022
- 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 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in research
- Being a 1st or 2nd-year student in the Faculty of Health Sciences, Department of Nursing
- Not have any health problems that may create a communication barrier
- Being in a quiet environment to participate in the online study due to the pandemic period
- Have an internet connection to attend online sessions
Who cannot join
- Having undergone abdominal surgery in the past three months
- Having a disability to attend regular sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Therapy on the General Health Status, Sleep Quality, and Stress Level of Nursing Students
The aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students.
Read the detailed description
H1.1: Students who receive laughter therapy will have lower mean scores in the general health questionnaire than students who do not receive laughter therapy.
H1.2: Students who receive laughter therapy will have a lower Pittsburgh sleep quality index score than students who do not receive laughter therapy.
H1.3: Students who receive laughter therapy will have a lower mean stress level than students who do not receive laughter therapy.
- Conditions
- Mental Stress, Insomnia, Sleep Disorder, Mental Health Disorder
- Being tested
- Laughter Therapy
- Keywords
- Sleep Quality, Psychological Stress, General Health, Nursing Students, Laughter Therapy
- Medical subject headings
- Stress, Psychological, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter TherapyBehavioural
The effect of the Laughter Therapy on nursing students
| Study group | Role | What they receive |
|---|---|---|
| Laughter Therapy Group | Experimental | A pre-test was administered to all students. In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index and Perceived Stress Scale were applied. Experimental and control groups were formed randomly among the students who filled all the scales. Communication groups were established for the students in both groups without being told which group they belonged to. Considering the hours suitable for the experimental group, 8 sessions of laughter therapy were applied for an average of 45 minutes. At the end of the therapy in the last session, a post-test was administered to all of the students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. Receives: Behavioral: Laughter Therapy |
| Control Group | No intervention | In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. At the end of the therapy in the last session, a post-test was administered to all students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
It was prepared by the researchers in line with the literature in order to collect data about the individual characteristics of the participants. Form; family structure, gender, income status, marital status, health status, age, etc. It consists of 13 items (pretest-posttest design was applied).
Measured: 2 minutes
General Health Questionnaire-28 (GHQ-28)
It was prepared to detect mental health problems. Individuals who score below 5 on the scale are evaluated as "normal", while individuals who score 5 and above are considered as a "risk group" in terms of mental health (pretest-posttest design was applied).
Measured: 5 minutes
Pittsburgh Sleep Quality Index (PUKI)
"Poor sleep quality" is expressed for individuals who score 5 and above from the scale. The scale consists of 24 items that evaluate sleep quality and disorders by scoring over a one-month period (pretest-posttest design was applied).
Measured: 5 minutes
Perceived Stress Scale (PSS)
The scale, which was prepared to evaluate the perceived stress level of the individual, consists of 14 items. High scores obtained from the scale indicate that the person has a high perception of stress(pretest-posttest design was applied).
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Feb 2021
- Primary completion30 May 2021
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies 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, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Uner, Muğla Sıtkı Koçman University
- Investigators
- Elif Uner, Dr, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681013
- Sponsor's protocol ID
- 739904
- Acronym
- Therapy
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 11 Jan 2023
- 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Therapy on the General Health Status, Sleep Quality, and Stress Level of Nursing Students
- ClinicalTrials.gov ID
- NCT05681013
- Acronym / sponsor ID
- Therapy / 739904
- Conditions
- Mental Stress, Insomnia, Sleep Disorder, Mental Health Disorder
- Keywords
- Sleep Quality, Psychological Stress, General Health, Nursing Students, Laughter Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 11 Jan 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.
The aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students.
Detailed description
H1.1: Students who receive laughter therapy will have lower mean scores in the general health questionnaire than students who do not receive laughter therapy.
H1.2: Students who receive laughter therapy will have a lower Pittsburgh sleep quality index score than students who do not receive laughter therapy.
H1.3: Students who receive laughter therapy will have a lower mean stress level than students who do not receive laughter therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter Therapy Group | Experimental | Behavioral: Laughter TherapyA pre-test was administered to all students. In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index and Perceived Stress Scale were applied. Experimental and control groups were formed randomly among the students who filled all the scales. Communication groups were established for the students in both groups without being told which group they belonged to. Considering the hours suitable for the experimental group, 8 sessions of laughter therapy were applied for an average of 45 minutes. At the end of the therapy in the last session, a post-test was administered to all of the students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. |
| Control Group | No intervention | –In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. At the end of the therapy in the last session, a post-test was administered to all students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering to participate in research
- Being a 1st or 2nd-year student in the Faculty of Health Sciences, Department of Nursing
- Not have any health problems that may create a communication barrier
- Being in a quiet environment to participate in the online study due to the pandemic period
- Have an internet connection to attend online sessions
Key exclusion criteria (2 listed)
- Having undergone abdominal surgery in the past three months
- Having a disability to attend regular sessions
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 TherapyThe effect of the Laughter Therapy on nursing students | Behavioural | Laughter Therapy Group |
Primary outcome
Introductory Information Form
Time frame: 2 minutes
It was prepared by the researchers in line with the literature in order to collect data about the individual characteristics of the participants. Form; family structure, gender, income status, marital status, health status, age, etc. It consists of 13 items (pretest-posttest design was applied).
General Health Questionnaire-28 (GHQ-28)
Time frame: 5 minutes
It was prepared to detect mental health problems. Individuals who score below 5 on the scale are evaluated as "normal", while individuals who score 5 and above are considered as a "risk group" in terms of mental health (pretest-posttest design was applied).
Pittsburgh Sleep Quality Index (PUKI)
Time frame: 5 minutes
"Poor sleep quality" is expressed for individuals who score 5 and above from the scale. The scale consists of 24 items that evaluate sleep quality and disorders by scoring over a one-month period (pretest-posttest design was applied).
Perceived Stress Scale (PSS)
Time frame: 3 minutes
The scale, which was prepared to evaluate the perceived stress level of the individual, consists of 14 items. High scores obtained from the scale indicate that the person has a high perception of stress(pretest-posttest design was applied).
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 11 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Elif Uner, Dr principal investigator
Muğla Sıtkı Koçman 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 Mental Stress and Insomnia, run by Muğla Sıtkı Koçman 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 5 inclusion and 2 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 11 Jan 2023. 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: 2 minutes). The study lists 4 primary outcomes in all. 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 11 Jan 2023.