Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

28 апреля 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

20

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Laughie checklists
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 февраля 2024 г.

Первичное завершение (Действительный)

29 февраля 2024 г.

Завершение исследования (Действительный)

30 августа 2024 г.

Даты регистрации исследования

Первый отправленный

21 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

28 апреля 2026 г.

Первый опубликованный (Действительный)

1 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • D69703

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться