跳至主要内容
临床试验/NCT07157176
NCT07157176已完成不适用

Laughie Prescription on the Well-being, Happiness, and Posttraumatic Stress Level of Nursing Students Affected by the Earthquake in Türkiye: A Randomized Controlled Trial

Hacettepe University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
1. Well-being

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Nursing students who have lived through the earthquake

排除标准

  • •Chronic respiration conditions; Heart conditions

研究组 & 干预措施

Experimental group

Experimental

Daily 3-Minute Laughter Practice (Laughie Prescription)"

干预措施: Daily 3-Minute Laughter Practice (Laughie Prescription) (Behavioral)

No Intervention

No Intervention

Control group The control group will not take part in the Laughie Prescription

结局指标

主要结局

1. Well-being

时间窗: 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:

时间窗: 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 :

时间窗: 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.

1. Well-being

时间窗: 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:

时间窗: 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 :

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilgun Kuru Alici

Associate Professor

Hacettepe University

研究点 (1)

Loading locations...

相似试验

Laughie Prescription on the Well-being, Happiness,... | 临床试验