Group Laughie Intervention for Well-Being in Earthquake Survivors: A Pilot Study
28 kwietnia 2026 zaktualizowane przez: Nilgun Kuru Alici, Hacettepe University
A Pilot Study Investigating the Feasibility, Reach-Out, Acceptability, Fidelity, and Efficacy of a Group Laughie Prescription on the Well-Being of Earthquake Survivors in Türkiye
Mental health and quality of life may be negatively impacted among earthquake survivors.
This pilot study aims to evaluate the feasibility, acceptability, and potential effects of a 1-minute Laughie (Laugh Intentionally Everyday) laughter prescription on well-being among earthquake survivors in Türkiye.
The study is designed as a within-subject pretest-posttest study including approximately 20 participants.
The Group Laughie intervention will be delivered once daily over a 2-week period, and participants will be instructed to engage in additional laughter practice using the Group Laughie recording twice daily, resulting in a total of 3 minutes of intentional laughter per day.
Data will be collected using a range of questionnaires to assess feasibility, reach, acceptability, fidelity, and well-being outcomes.
Measures include Laughie Checklists, a Post-Intervention Perceived Impact Measure (PIPIM), and the World Health Organization Well-Being Index (WHO-5).
The findings of this study are expected to provide preliminary evidence regarding the feasibility and potential impact of a brief online laughter intervention on psychological well-being in earthquake survivors.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ankara, Turcja (Türkiye)
- Hacettepe University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria Adults aged 18 to 65 years Ability to use a smartphone or other smart device Ability to access and participate in online sessions Willingness to participate in the study Ability to provide informed consent Exclusion Criteria Individuals who do not meet the inclusion criteria Individuals unable to participate in online group sessions
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Pre-test
Participants assigned to this arm will receive a Group Laughie intervention delivered by a trained nurse and certified laughter yoga instructor.
The intervention consists of virtual group sessions conducted via an online platform (e.g., Zoom).
Participants will attend one session per day for 14 days, during which they will engage in 1 minute of intentional group laughter to create a Group Laughie.
Each session will be recorded, and the recording will be shared with participants.
Participants will be instructed to engage in additional laughter practice using the Group Laughie recording twice daily, resulting in a total of approximately 3 minutes of intentional laughter per day.
Participants will be encouraged to laugh naturally and voluntarily, either individually or with others, and may focus on personal motivations such as enhancing well-being or positive affect.
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The intervention is a group-based Laughie (Laugh Intentionally Everyday) prescription delivered over 14 consecutive days.
Laughie is a structured well-being approach that incorporates intentional smiling and laughter exercises.
The intervention will be delivered through daily virtual group sessions conducted via an online platform (e.g., Zoom).
During each session, participants will engage in approximately 1 minute of guided intentional laughter in a group setting.
Each session will be recorded, and participants will be provided access to the Group Laughie recording.
Participants will be instructed to engage in additional laughter practice using the recording twice daily, resulting in approximately 3 minutes of intentional laughter per day.
The group-based format is designed to support participant engagement and social interaction during the intervention period.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Laughie checklists
Ramy czasowe: At baseline (prior to intervention) and immediately after the 14-day intervention
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Following the Group Laughie participants noted whether they enjoyed it, and whether they laughed for the full minute, or at least for 30 s. Participants were prescribed to laugh with their Group Laughie twice a day.
Similarly, and in addition, participants noted if they enjoyed laughing with the Group Laughie and whether they laughed for the full minute, or at least 30 s, after each time.
This resulted in data from 840 Laughie experiences (3 × 14 × 20).
This data is briefly summarized in the Results section
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At baseline (prior to intervention) and immediately after the 14-day intervention
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Laughie checklists
Ramy czasowe: At baseline (prior to intervention) and immediately after the 14-day intervention
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Following the Group Laughie participants noted whether they enjoyed it, and whether they laughed for the full minute, or at least for 30 s. Participants were prescribed to laugh with their Group Laughie twice a day.
Similarly, and in addition, participants noted if they enjoyed laughing with the Group Laughie and whether they laughed for the full minute, or at least 30 s, after each time.
This resulted in data from 840 Laughie experiences (3 × 14 × 20).
This data is briefly summarized in the Results section.
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At baseline (prior to intervention) and immediately after the 14-day intervention
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Laughie experience questionnaire
Ramy czasowe: Immediately after the 14-day intervention
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The Laughie Experience Questionnaire is a post-intervention questionnaire designed to assess participant experience and intervention acceptability.
The questionnaire includes items evaluating enjoyment and perceived experience of the 14-day Laughie prescription and daily group sessions.
Participants will respond to statements (e.g., enjoyment of the intervention and group sessions) using a 5-point Likert scale ranging from "strongly agree" to "strongly disagree."
The measure is adapted for use in this study based on previously developed Laughie-related questionnaires.
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Immediately after the 14-day intervention
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Post intervention perceived impact measure (PIPIM): the PPOP
Ramy czasowe: Immediately after the 14-day intervention
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The PIPIM is a new descriptive generic post-intervention descriptive measure designed to draw out intervention perceived impact (IPI) by aligning all questions to the intervention being used.
Here, the PIPIM used was an adapted version of the PPOP (Positive Psychology One-off Post-intervention measure) conceived by one of the authors and first applied in citizen science research.
The PPOP consists of 20 questions including "Do you feel more happy and cheerful after using the Laughie for 14 days" and "Do you have more energy after using the Laughie for 14 days".
PIPIMs use an 11-point Likert scale (0 to 10): "A great deal less; A lot less; A fair bit less; A little less; A tiny bit less; The same; A tiny bit more; A little more; A fair bit more; A lot more; A great deal more"
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Immediately after the 14-day intervention
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WHO five well-being index (WHO-5)
Ramy czasowe: Baseline and Day 14 (end of intervention)
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The WHO-5 Well-being Index (WHO-5; World Health Organization, Citation1998), 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. (Citation2019), 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.
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Baseline and Day 14 (end of intervention)
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Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
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Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
15 lutego 2024
Zakończenie podstawowe (Rzeczywisty)
29 lutego 2024
Ukończenie studiów (Rzeczywisty)
30 sierpnia 2024
Daty rejestracji na studia
Pierwszy przesłany
21 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 kwietnia 2026
Pierwszy wysłany (Rzeczywisty)
1 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
1 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 kwietnia 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- D69703
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Yes. Individual participant data that underlie the results reported in this study will be made available to qualified researchers upon reasonable request, after de-identification and in accordance with ethical and institutional requirements.
Because the study involves a potentially vulnerable population and includes sensitive interview-based data, only data that can be sufficiently anonymized will be shared.
Data sharing will require a methodologically sound proposal, approval by the principal investigator, and, where applicable, a data use agreement to ensure confidentiality and appropriate use of the data.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Laughie
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Hacettepe UniversityJeszcze nie rekrutacjaOparzenie | Oparzenia drugiego stopniaTurcja (Türkiye)