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Group Laughie Intervention for Well-Being in Earthquake Survivors: A Pilot Study

28 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

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Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Laughie checklists
Lasso di tempo: At baseline (prior to intervention) and immediately after the 14-day intervention
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
At baseline (prior to intervention) and immediately after the 14-day intervention
Laughie checklists
Lasso di tempo: At baseline (prior to intervention) and immediately after the 14-day intervention
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.
At baseline (prior to intervention) and immediately after the 14-day intervention
Laughie experience questionnaire
Lasso di tempo: Immediately after the 14-day intervention
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.
Immediately after the 14-day intervention
Post intervention perceived impact measure (PIPIM): the PPOP
Lasso di tempo: Immediately after the 14-day intervention
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"
Immediately after the 14-day intervention
WHO five well-being index (WHO-5)
Lasso di tempo: Baseline and Day 14 (end of intervention)
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.
Baseline and Day 14 (end of intervention)

Collaboratori e investigatori

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Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 febbraio 2024

Completamento primario (Effettivo)

29 febbraio 2024

Completamento dello studio (Effettivo)

30 agosto 2024

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • D69703

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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