Effect of Laughie on Pain Anxiety and Pain Level in Second-Degree Burn Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHacettepe University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Laughie
Other interventionOne 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Change from baseline scores at the end of 15 minutes.Secondary outcomes
1
The Visual Analog Scale (VAS)
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.
Time frame
Change from baseline scores at the end of 15 minutes.Sponsors and contacts
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Source ClinicalTrials.gov
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