NCT07157176

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
Last Updated

September 11, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

August 16, 2025

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 1. Well-being

    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.

    Baseline (Day 1) and End of Intervention (Day 2)

  • 2. Happiness:

    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.

    Baseline (Day 1) and End of Intervention (Day 2)

  • 3. Post-traumatic stress :

    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.

    Baseline (Day 1) and End of Intervention (Day 2)

Study Arms (2)

Experimental group

EXPERIMENTAL

Daily 3-Minute Laughter Practice (Laughie Prescription)"

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

No Intervention

NO INTERVENTION

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

Interventions

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)

Experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nursing students who have lived through the earthquake

You may not qualify if:

  • Chronic respiration conditions; Heart conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2025

First Posted

September 5, 2025

Study Start

April 1, 2025

Primary Completion

May 30, 2025

Study Completion

August 1, 2025

Last Updated

September 11, 2025

Record last verified: 2025-02

Locations