NCT07773181

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Jul 2028

First Submitted

Initial submission to the registry

August 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

August 12, 2026

Last Update Submit

August 16, 2026

Conditions

Burns and Scalds

Keywords

aromatherapyburnschildinfant

Outcome Measures

Primary Outcomes (1)

  • 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

    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).

Study Arms (2)

Control Arm: Usual care

NO INTERVENTION

Intervention Arm

EXPERIMENTAL

Participant will wait in the aromatherapy waiting room for 15 minutes prior to dressing change.

Other: Aromatherapy

Interventions

AromatherapyOTHER

Aromatherapy diffusion is a blend of three essential oils, bergamot mint, patchouli, and sweet orange.

Intervention Arm

Eligibility Criteria

Age2 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women and Children's Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Burns

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eugenie Spiguel, PhD

    KK Women and Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenie Spiguel, PhD

CONTACT

+65 6225 5554spiguel.eugenie.ann@kkh.com.sg

Joanne Cheng, DNP

CONTACT

joanne.cheng.sh@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized control trial comparing aromatherapy with usual care
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 19, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

SG(1)