BurnLA-PAPNCT07386821
Effect of Laughie on Pain Anxiety and Pain Level in Second-Degree Burn Patients
A study testing Laughie in people with Burn and Second Degree Burns, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Second Degree Burns
- What is being tested?
- Laughie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Merve Akın, MD, Assoc. Prof. contact
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Altındağ, 06230
Burcu Duluklu, Phd, Asst. Prof., +905334732070, duluklu@hacettepe.edu.tr
About this study
Official title: 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.
- Conditions
- Burn, Second Degree Burns
- Being tested
- Laughie
- Keywords
- burn, laughie, pain, pain anxiety
- Medical subject headings
- Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaughieOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Laughie Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline scores at the end of 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Duluklu, Hacettepe University
- Investigators
- Burcu Duluklu, PhD, Asst. Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386821
- Sponsor's protocol ID
- TABED 2-25-1864
- Acronym
- LA-PAP
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughie Exercise on Pain Anxiety and Pain Level in Second-Degree Burn Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07386821
- Acronym / sponsor ID
- LA-PAP / TABED 2-25-1864
- Conditions
- Burn, Second Degree Burns
- Keywords
- burn, laughie, pain, pain anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: LaughieLaughie |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaughieOne 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. | Other | Intervention Group |
Primary outcome
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.
1 secondary outcome
The Visual Analog Scale (VAS)
Time frame: Change from baseline scores at the end of 15 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merve Akın, MD, Assoc. Prof. contact
Burcu Duluklu, PhD, Asst. Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughie in people with Burn and Second Degree Burns, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu Duluklu, PhD, Asst. Prof. (+905334732070, duluklu@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Burn Specific Pain Anxiety (time frame: Change from baseline scores at the end of 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.