Effect of Laughie on Pain Anxiety and Pain Level in Second-Degree Burn Patients (LA-PAP)

February 3, 2026 updated by: Burcu Duluklu, Hacettepe University

The Effect of Laughie Exercise on Pain Anxiety and Pain Level in Second-Degree Burn Patients: A Randomised Controlled Trial

Burn injuries are traumatic conditions that seriously affect individuals' quality of life, both physically and psychologically. Second-degree burns, in particular, affect the superficial and/or deep layers of the dermis, causing intense pain and extensive tissue damage. Pain in burn patients is not only physical; it combines with emotional stress, fear, and uncertainty to increase anxiety levels.

This study is a parallel group-randomised controlled trial designed to evaluate the effects of the Laughie exercise, administered prior to dressing changes in individuals diagnosed with second-degree burns, on post-dressing pain anxiety levels and pain intensity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Merve Akın, MD, Assoc. Prof.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age and over
  • Having a second degree burn
  • Arriving for the second dressing change on the unit
  • To agree to participate in the research

Exclusion Criteria:

  • In multiple burns, a burn degree other than the second degree on any part of the body
  • A maximum of 96 hours have elapsed since the burn injury
  • To have come to the dressing in repetitions other than the second dressing
  • Inability to tolerate the Laughie exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Laughie
Other: Laughie

One alternative and complementary medicine approach that has gained attention is the Laughie technique, also known as guided laughter exercise. Laughie enables individuals to laugh in a controlled manner using their own voice, targeting the physiological and psychological benefits of laughter.

In this study, Laughie involves recording a one-minute video of the patient's natural laughter. Before the dressing change, patients watch this video and accompany their laughter to support autonomic nervous system stabilization.

For patients presenting for their second dressing change, the study procedure will include the following steps: (1) collection of descriptive characteristics; (2) assessment of pain severity and pain anxiety levels 5-10 minutes before the dressing change; (3) administration of the Laughie exercise five minutes before the dressing change; (4) application of the dressing; and (5) reassessment of pain severity and pain anxiety levels five minutes after the procedure.
No Intervention: Control Group

Control:

Second-degree burn patients. For patients presenting for their second dressing change, standard dressing change prosedures will be applied. The study procedure will include the following steps: (1) collection of descriptive characteristics; (2) assessment of pain severity and pain anxiety levels 5-10 minutes before the dressing change; (3) application of the dressing; (4) reassessment of pain severity and pain anxiety levels five minutes after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Burn Specific Pain Anxiety
Time Frame: Change from baseline scores at the end of 15 minutes.
The Burn Specific Pain Anxiety Scale (BSPAS) consists of nine items. The scale was designed to assess pain-related anxiety in patients with burn injuries. The Turkish version includes eight items, each rated on a two-ended visual analog scale ranging from 0 to 10, with anchor points defined as "none at all" (0) and "in the worst possible way" (10). Total scores are calculated by summing the item scores, yielding a possible range from 0 to 80. Higher total scores reflect greater levels of pain-related anxiety experienced by patients during painful hospital procedures. The internal consistency of the Turkish version was excellent, with a Cronbach's α coefficient of 0.95.
Change from baseline scores at the end of 15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS)
Time Frame: Change from baseline scores at the end of 15 minutes.
The Visual Analog Scale (VAS) is a widely used, simple, and reliable tool for assessing subjective experiences such as pain intensity. It typically consists of a 10-cm horizontal or vertical line anchored by two endpoints representing extreme states, ranging from "no pain" to "worst imaginable pain." Patients are asked to indicate the point that best reflects their current level of pain, providing a quantitative measure of pain severity that is easy to administer and sensitive to change.
Change from baseline scores at the end of 15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Burcu Duluklu, PhD, Asst. Prof., Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 2-25-1864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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