Burns and ScaldsNCT07773181
Nurse Led Aromatherapy
A study testing Aromatherapy in people with Burns and Scalds, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
The goal of this trial is to see if aromatherapy in addition to pain medication, will help manage pain in pediatric burn patients during their first burn dressing change. Participants aged 2 months to 7 years old will be randomly assigned to usual care (pain medication only) or to receive aromatherapy in addition to… Read more about this study
- Who is it for?
- Ages 2 months to 7 years
- Conditions the study is for
- Burns and Scalds
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2026to Jul 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 2 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Seen in outpatient burn center
- Burns not covering more than 7.5% of body surface area
- First burn dressing change
- Second degree burns
- Scalding, flame, or contact burns
Who cannot join
- Allergy/hypersensitivity to essential oils, or any components of the aromatherapy formula
- Airway/hypersensitivity to fragrances, paint fumes, or turpentine
- Respiratory conditions (e.g. asthma, reactive airway disease, recent wheezing)
- Inhalation injury
- Thermal injury: Caused by direct thermal damage which affects upper airways resulting in edema, stridor and upper airway obstruction
- Chemical injury to airways and lung parenchyma from products of combustion
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- Systemic poisoning from carbon monoxide and/or cyanide
- Surgery for burn
- Infection of burn
- Burns of the face
- Burns requiring Acticoat dressing
- Delayed burns (those that have been previously treated outside of the hospital, but have not healed and require further treatment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joanne Cheng, DNP contact
Singapore1 site
KK Women and Children's Hospital
Singapore
Teo Agnes, Research Coordinator, +65 6225 5554, agnes.teo.p.c@singhealth.com.sg
Eugenie SpiguelPh, PhD
About this study
The goal of this trial is to see if aromatherapy in addition to pain medication, will help manage pain in pediatric burn patients during their first burn dressing change. Participants aged 2 months to 7 years old will be randomly assigned to usual care (pain medication only) or to receive aromatherapy in addition to pain medication prior to their first burn dressing change. The main question it aims to answer is:
-Does aromatherapy plus pain medication decrease pain more than pain medication alone for young children receiving their first burn dressing change?
Read more
All participants will receive the standard pain medications and have their pain assessed on medication administration (prior to aromatherapy for the intervention group), prior to dressing change (after aromatherapy for the intervention group), and 15 minutes after the dressing change is complete.
Once the final pain assessment is complete, there is no more information needed from participants for the purposes of the study. All participants will continue to follow up in the clinic for the remaining dressing changes as needed.
- Conditions
- Burns and Scalds
- Being tested
- Aromatherapy
- Keywords
- aromatherapy, burns, child, infant
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Aromatherapy diffusion is a blend of three essential oils, bergamot mint, patchouli, and sweet orange.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Usual care | No intervention | Not described |
| Intervention Arm | Experimental | Participant will wait in the aromatherapy waiting room for 15 minutes prior to dressing change. Receives: Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score as measured by Face, Legs, Activity, Cry, and Consolability (FLACC) scale with first burn dressing change
Zero is equivalent to no pain and 10 indicates severe pain
Measured: FLACC to be completed upon arrival in burn center (baseline), immediately prior to burn dressing change (preprocedural), and 15 minutes after burn dressing change is complete (postprocedural).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns and ScaldsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial comparing aromatherapy with usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National Cancer Centre, Singapore
- Responsible party
- Principal investigator, Spiguel Eugenie Ann, KK Women's and Children's Hospital
- Investigators
- Eugenie Spiguel, PhD, Principal investigator, KK Women and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773181
- Sponsor's protocol ID
- 2026-0176
- Other IDs
- MCHRI/FY2024/EX/30-A82
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While we are collaborating with another institution for the aromatherapy formula, the patients will be recruited only from our institution, therefore IPD does not need to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Led Aromatherapy
- ClinicalTrials.gov ID
- NCT07773181
- Acronym / sponsor ID
- 2026-0176
- Conditions
- Burns and Scalds
- Keywords
- aromatherapy, burns, child, infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National Cancer Centre, Singapore
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Aug 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.
The goal of this trial is to see if aromatherapy in addition to pain medication, will help manage pain in pediatric burn patients during their first burn dressing change. Participants aged 2 months to 7 years old will be randomly assigned to usual care (pain medication only) or to receive aromatherapy in addition to pain medication prior to their first burn dressing change. The main question it aims to answer is:
-Does aromatherapy plus pain medication decrease pain more than pain medication alone for young children receiving their first burn dressing change?
All participants will receive the standard pain medications and have their pain assessed on medication administration (prior to aromatherapy for the intervention group), prior to dressing change (after aromatherapy for the intervention group), and 15 minutes after the dressing change is complete.
Once the final pain assessment is complete, there is no more information needed from participants for the purposes of the study. All participants will continue to follow up in the clinic for the remaining dressing changes as needed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial comparing aromatherapy with usual care
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Usual care | No intervention | – |
| Intervention Arm | Experimental | Other: AromatherapyParticipant will wait in the aromatherapy waiting room for 15 minutes prior to dressing change. |
Who may qualify
- Ages
- 2 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Seen in outpatient burn center
- Burns not covering more than 7.5% of body surface area
- First burn dressing change
- Second degree burns
- Scalding, flame, or contact burns
Key exclusion criteria (12 listed)
- Allergy/hypersensitivity to essential oils, or any components of the aromatherapy formula
- Airway/hypersensitivity to fragrances, paint fumes, or turpentine
- Respiratory conditions (e.g. asthma, reactive airway disease, recent wheezing)
- Inhalation injury
- Surgery for burn
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 |
|---|---|---|
| AromatherapyAromatherapy diffusion is a blend of three essential oils, bergamot mint, patchouli, and sweet orange. | Other | Intervention Arm |
Primary outcome
Pain score as measured by Face, Legs, Activity, Cry, and Consolability (FLACC) scale with first burn dressing change
Time frame: FLACC to be completed upon arrival in burn center (baseline), immediately prior to burn dressing change (preprocedural), and 15 minutes after burn dressing change is complete (postprocedural).
Zero is equivalent to no pain and 10 indicates severe pain
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 19 Aug 2026.
- Individual participant dataSharing planned: No. While we are collaborating with another institution for the aromatherapy formula, the patients will be recruited only from our institution, therefore IPD does not need to be shared.
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.
Joanne Cheng, DNP contact
Eugenie Spiguel, PhD principal investigator
KK Women and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Burns and Scalds, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 5 inclusion and 12 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 19 Aug 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 Singapore. 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 Eugenie Spiguel, PhD (+65 6225 5554, spiguel.eugenie.ann@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score as measured by Face, Legs, Activity, Cry, and Consolability (FLACC) scale with first burn dressing change (time frame: FLACC to be completed upon arrival in burn center (baseline), immediately prior to burn dressing change (preprocedural), and 15 minutes after burn dressing change is complete (postprocedural).). 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 19 Aug 2026.