- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07563140
Group Laughie Intervention for Well-Being in Earthquake Survivors: A Pilot Study
28 de abril de 2026 atualizado por: 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.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ankara, Turquia (Türkiye)
- Hacettepe University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Laughie checklists
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
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Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de fevereiro de 2024
Conclusão Primária (Real)
29 de fevereiro de 2024
Conclusão do estudo (Real)
30 de agosto de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
21 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de abril de 2026
Primeira postagem (Real)
1 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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