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NCT Number: NCT07386821

Effect of Laughie on Pain Anxiety and Pain Level in Second-Degree Burn Patients

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.

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Key information

Conditions

Burn Burns Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Second Degree Burns Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location contact

Burcu Duluklu, Phd, Asst. Prof.

CONTACT

[email protected]

+905334732070

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laughie

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu Duluklu, PhD, Asst. Prof.

CONTACT

[email protected]

+905334732070

Merve Akın, MD, Assoc. Prof.

CONTACT

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Acronym: LA-PAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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