Well BeingNCT07157176
Laughie Prescription on the Well-being, Happiness, and Posttraumatic Stress Level of Nursing Students Affected by the Earthquake
A study testing Daily 3-Minute Laughter Practice (Laughie Prescription) in people with Well Being and Happiness, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of the Laughie Prescription on Well-being, Happiness, and Postraumatic stress levels of nursing students affected by the earthquake in Türkiye. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Well Being, Happiness, Post Traumatic Stress Disorders
- What is being tested?
- Daily 3-Minute Laughter Practice (Laughie Prescription)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Aug 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nursing students who have lived through the earthquake
Who cannot join
- Chronic respiration conditions; Heart conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laughie Prescription on the Well-being, Happiness, and Posttraumatic Stress Level of Nursing Students Affected by the Earthquake in Türkiye: A Randomized Controlled Trial
This study aimed to evaluate the effect of the Laughie Prescription on Well-being, Happiness, and Postraumatic stress levels of nursing students affected by the earthquake in Türkiye. The study hypothesises that the Laughie Prescription would have a positive effect on well-being, happiness, and lowering post-traumatic stress level scores among nursing students affected by the earthquake in Türkiye. The CONSORT-SPI 18 Checklist for the reporting of randomised trials of social and psychological interventions was adhered to in the development of this protocol.
Read the detailed description
Purpose: The aim of the research is to examine the effects of the Laughie Prescription: if it would have a positive effect on well-being, happiness, and post-traumatic stress level scores among nursing students affected by the earthquake in Türkiye.
Methods: The study will conduct with 60 (30 in the intervention group, and 30 in the control group) nursing students. The study population in the intervention group will apply the intervention three times a day for one week. No intervention will be offered to the control group.
Recruitment: Participants will be recruited from the School of Nursing at XX University, in Hatay Turkiye - recruitment will be voluntary Randomization: Participants will be randomly assigned to either the control or the intervention group through a block randomisation prompt, where the block size is 5, within the Qualtrics link at the time participants sign up to the study. Authors involved in the analysis of the data will be blinded to participants' group allocation.
Intervention: The intervention will consist of 3-minutes of laughter (joyful and natural laughter is recommended) per day. Each day participants will laugh for one minute in a group (virtual and/or actual) guided by a professional laughter practitioner who is not going to be involved in the analysis of the data. That laughter will be recorded. The recording (the "Laughie") will then be prescribed for participants to laugh with (with others - family, friends, colleagues, or alone) twice a day. This will result in 3 minutes of laughter per day (the first in a group, the second two prompted by the Laughie).
Data will be collected with a socio- demographic questionnaire, and Well-being, Happiness, and Postraumatic Stress Level Scales.
Participants randomly allocated to the control group will be instructed to complete the questionnaires at baseline and follow-up but will not take part in any intervention.
- Conditions
- Well Being, Happiness, Post Traumatic Stress Disorders
- Being tested
- Daily 3-Minute Laughter Practice (Laughie Prescription)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily 3-Minute Laughter Practice (Laughie Prescription)Behavioural
The intervention will consist of 3-minutes of laughter (joyful and natural laughter is recommended) per day. Each day participants will laugh for one minute in a group (virtual and/or actual) guided by a professional laughter practitioner who is not going to be involved in the analysis of the data. That laughter will be recorded. The recording (the "Laughie") will then be prescribed for participants to laugh with (with others - family, friends, colleagues, or alone) twice a day. This will result in 3 minutes of laughter per day (the first in a group, the second two prompted by the Laughie)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Daily 3-Minute Laughter Practice (Laughie Prescription)" Receives: Behavioral: Daily 3-Minute Laughter Practice (Laughie Prescription) |
| No Intervention | No intervention | Control group The control group will not take part in the Laughie Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Well-being
The WHO-5 Well-being Index (WHO-5; World Health Organization, 1998), a widely used and validated measure, was administered pre- and post-intervention as a self-report well-being measure. Eser et al. validated and established the reliability of the WHO-5 Turkish scale in their 2019 study. Based on guidance from Eser et al. (2019), the WHO-5 Turkish scale could be used without seeking explicit permission, provided it was cited appropriately. The scale consists of five items (e.g. 'In the last 2 weeks, I have felt cheerful and in good spirits') rated on a 6-point Likert scale grading; At no time = 0, some of the time = 1, less than half of time = 2, more than half of time = 3, most of the time = 4, all of the time = 5. The scoring of the scale is done by summing the score obtained from each item, and the highest score that can be obtained from the scale is 25 and the lowest score is 0.
Measured: Baseline (Day 1) and End of Intervention (Day 2)
2. Happiness:
The Oxford Happiness Questionnaire (OHQ-8) is an abbreviated version of the OHQ-29. It was developed to measure personal happiness and subjective well-being. The original OHQ-29 followed the format of the Beck Depression Inventory, with 20 items reversed and nine additional items added to cover aspects of happiness. The OHQ-29 is a single-scale questionnaire that can be answered on a standard six-point Likert scale. Almost half of the items (14) are negatively worded to reduce respondent bias.
Measured: Baseline (Day 1) and End of Intervention (Day 2)
3. Post-traumatic stress :
The National Stressful Events Survey for PTSD Short Scale (NSESSS-PTSD) was used to assess PTSD symptoms. This scale is a 9-item assessment of the dimensions of post-traumatic stress disorder by DSM-5 criteria. Participants rate each item on a five-point Likert scale ranging from 0 ('never') to 4 ('always'). The total score ranges from 0 to 36, with higher scores indicating more severe symptoms of PTSD. The Turkish version of the PTSD short scale is a valid and reliable measure (alpha = 0.87) for the assessment of PTSD symptoms in the Turkish population.
Measured: Baseline (Day 1) and End of Intervention (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Apr 2025
- Primary completion30 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well BeingStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Derby, Mustafa Kemal University
- Responsible party
- Principal investigator, Nilgun Kuru Alici, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157176
- Sponsor's protocol ID
- D69072
- Other IDs
- Hacettepe University, Hacettepe University
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laughie Prescription on the Well-being, Happiness, and Posttraumatic Stress Level of Nursing Students Affected by the Earthquake in Türkiye: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07157176
- Acronym / sponsor ID
- D69072
- Conditions
- Well Being, Happiness, Post Traumatic Stress Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- University of Derby, Mustafa Kemal University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 5 Sep 2025 (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.
This study aimed to evaluate the effect of the Laughie Prescription on Well-being, Happiness, and Postraumatic stress levels of nursing students affected by the earthquake in Türkiye. The study hypothesises that the Laughie Prescription would have a positive effect on well-being, happiness, and lowering post-traumatic stress level scores among nursing students affected by the earthquake in Türkiye. The CONSORT-SPI 18 Checklist for the reporting of randomised trials of social and psychological interventions was adhered to in the development of this protocol.
Detailed description
Purpose: The aim of the research is to examine the effects of the Laughie Prescription: if it would have a positive effect on well-being, happiness, and post-traumatic stress level scores among nursing students affected by the earthquake in Türkiye.
Methods: The study will conduct with 60 (30 in the intervention group, and 30 in the control group) nursing students. The study population in the intervention group will apply the intervention three times a day for one week. No intervention will be offered to the control group.
Recruitment: Participants will be recruited from the School of Nursing at XX University, in Hatay Turkiye - recruitment will be voluntary Randomization: Participants will be randomly assigned to either the control or the intervention group through a block randomisation prompt, where the block size is 5, within the Qualtrics link at the time participants sign up to the study. Authors involved in the analysis of the data will be blinded to participants' group allocation.
Intervention: The intervention will consist of 3-minutes of laughter (joyful and natural laughter is recommended) per day. Each day participants will laugh for one minute in a group (virtual and/or actual) guided by a professional laughter practitioner who is not going to be involved in the analysis of the data. That laughter will be recorded. The recording (the "Laughie") will then be prescribed for participants to laugh with (with others - family, friends, colleagues, or alone) twice a day. This will result in 3 minutes of laughter per day (the first in a group, the second two prompted by the Laughie).
Data will be collected with a socio- demographic questionnaire, and Well-being, Happiness, and Postraumatic Stress Level Scales.
Participants randomly allocated to the control group will be instructed to complete the questionnaires at baseline and follow-up but will not take part in any intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Daily 3-Minute Laughter Practice (Laughie Prescription)Daily 3-Minute Laughter Practice (Laughie Prescription)" |
| No Intervention | No intervention | –Control group The control group will not take part in the Laughie Prescription |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nursing students who have lived through the earthquake
Key exclusion criteria (1 listed)
- Chronic respiration conditions; Heart conditions
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 |
|---|---|---|
| Daily 3-Minute Laughter Practice (Laughie Prescription)The intervention will consist of 3-minutes of laughter (joyful and natural laughter is recommended) per day. Each day participants will laugh for one minute in a group (virtual and/or actual) guided by a professional laughter practitioner who is not going to be involved in the analysis of the data. That laughter will be recorded. The recording (the "Laughie") will then be prescribed for participants to laugh with (with others - family, friends, colleagues, or alone) twice a day. This will result in 3 minutes of laughter per day (the first in a group, the second two prompted by the Laughie) | Behavioural | Experimental group |
Primary outcome
1. Well-being
Time frame: Baseline (Day 1) and End of Intervention (Day 2)
The WHO-5 Well-being Index (WHO-5; World Health Organization, 1998), a widely used and validated measure, was administered pre- and post-intervention as a self-report well-being measure. Eser et al. validated and established the reliability of the WHO-5 Turkish scale in their 2019 study. Based on guidance from Eser et al. (2019), the WHO-5 Turkish scale could be used without seeking explicit permission, provided it was cited appropriately. The scale consists of five items (e.g. 'In the last 2 weeks, I have felt cheerful and in good spirits') rated on a 6-point Likert scale grading; At no time = 0, some of the time = 1, less than half of time = 2, more than half of time = 3, most of the time = 4, all of the time = 5. The scoring of the scale is done by summing the score obtained from each item, and the highest score that can be obtained from the scale is 25 and the lowest score is 0.
2. Happiness:
Time frame: Baseline (Day 1) and End of Intervention (Day 2)
The Oxford Happiness Questionnaire (OHQ-8) is an abbreviated version of the OHQ-29. It was developed to measure personal happiness and subjective well-being. The original OHQ-29 followed the format of the Beck Depression Inventory, with 20 items reversed and nine additional items added to cover aspects of happiness. The OHQ-29 is a single-scale questionnaire that can be answered on a standard six-point Likert scale. Almost half of the items (14) are negatively worded to reduce respondent bias.
3. Post-traumatic stress :
Time frame: Baseline (Day 1) and End of Intervention (Day 2)
The National Stressful Events Survey for PTSD Short Scale (NSESSS-PTSD) was used to assess PTSD symptoms. This scale is a 9-item assessment of the dimensions of post-traumatic stress disorder by DSM-5 criteria. Participants rate each item on a five-point Likert scale ranging from 0 ('never') to 4 ('always'). The total score ranges from 0 to 36, with higher scores indicating more severe symptoms of PTSD. The Turkish version of the PTSD short scale is a valid and reliable measure (alpha = 0.87) for the assessment of PTSD symptoms in the Turkish population.
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 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily 3-Minute Laughter Practice (Laughie Prescription) in people with Well Being and Happiness, run by Hacettepe 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 1 inclusion and 1 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 Sep 2025. 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?
1. Well-being (time frame: Baseline (Day 1) and End of Intervention (Day 2)). The study lists 3 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 Sep 2025.