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

NCT07386821 | Not Yet Recruiting

• 1 other identifier: TABED 2-25-1864
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burn; Second Degree Burns

Keywords

burn; laughie; pain; pain anxiety

Outcome Measures

Primary Outcomes (1)

• 1. Burn Specific Pain Anxiety

  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 Outcomes (1)

• The Visual Analog Scale (VAS)

  Change from baseline scores at the end of 15 minutes.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Laughie

Other: Laughie

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Burcu Duluklu, PhD, Asst. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu Duluklu, PhD, Asst. Prof.

CONTACT

+905334732070; duluklu@hacettepe.edu.tr

Merve Akın, MD, Assoc. Prof.

CONTACT

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: Asst. Prof.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)