Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108648
• Other study ID #: 2022-01116
• Status: Recruiting
• Phase: Phase 4
• Start date: December 7, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Geneva
• Contact: Fabiola Stollar, MD, PhD
• Phone: +41795534380
• Email: Fabiola.stollar[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if lavender essential oil chest wraps relieve cough in infants with bronchiolitis compared to standard care. Furthermore, the researchers will evaluate if breathing difficulties, nighttime awakening and impact on parents will be improved by the lavender oil chest wraps. Infants will be randomized to receive standard care with the addition of lavender oil chest wraps or to receive standard care alone. The study will take place in two locations in Switzerland, at the Geneva University Hospital and the Fribourg Cantonal Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 11 Months

Eligibility

Inclusion criteria:

• Bronchiolitis: clinical diagnosis based on the combination of respiratory distress (tachypnea, grunting, nasal flaring, retractions, and/or need for supplementary oxygen) and fine crackles sometimes accompanied by wheezing on auscultation.
• Hospitalization.
• Written informed consent.

Exclusion criteria:

• Patients with underlying diseases that impact respiratory or heart function (congenital heart disease, congenital malformation of the lung or airway system and severe chronic lung disease).
• More than 3 episodes of bronchiolitis.
• Critically ill infants who have an immediate need for intensive care unit (ICU) admission.
• Respiratory deterioration needing Continuous positive airway pressure (CPAP) or transfer to ICU during study enrollment.
• Atopic dermatitis, eczema or other skin lesions (particularly on the chest).
• Oncologic disease.
• Premature infants with mild bronchopulmonary dysplasia will not be excluded.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Lavender essential oil 10%, diluted in 90% olive oil
Lavender chest wrap: Before the first application pour 10-15 ml of lavender essential oil 10% evenly on the cotton cloth. Put the soaked cotton in the plastic bag, close it and put it to heat in two heating pads (2-5 minutes) so that the oil is distributed on all the fabric. Place the cotton cloth around the patient's chest. Cover the cotton cloth with a woolen fabric that is 2 cm larger than the cotton cloth.

Other:
• Control
Standard care according to national standards.

Locations

Country	Name	City	State
Switzerland	Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland	Fribourg
Switzerland	Children's' Hospital, University Hospital of Geneva, Switzerland	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough frequency	Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)	Up to 2 days
Secondary	Crying episodes	Number of crying episodes noted by parents on crying calendar	Up to 2 days
Secondary	Respiratory rate	Number of breaths per minute	Baseline, 1 hour, 4 hours
Secondary	Oxygen supplementation requirement	Presence of oxygen supplementation during hospital stay (yes/no)	Immediately at discharge from hospital
Secondary	Oxygen supplementation duration	Number of hours of oxygen supplementation	Immediately at discharge from hospital
Secondary	Maximum oxygen supplementation	Maximum oxygen flow in L/min	Immediately at discharge from hospital
Secondary	Hospital length of stay	Hospital length of stay in number of days, Geneva site only	Immediately at discharge from hospital
Secondary	Parental satisfaction assessed with patient satisfaction questionnaire	Satisfaction of parents will be measured by a 10-item, four-point Likert scale questionnaire that has a 3-dimensional structure, i.e. overall satisfaction; perceived effectiveness; parental information and involvement. Scale range from 1 (not at all) to 4 (a lot). Higher scores indicate greater satisfaction.	Immediately at discharge from hospital
Secondary	Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ)	Impact from the hospitalization on parents will be measured using IBHQ, a 46-item, four-point Likert scale that has a 12-dimensional structure, i.e. worries and distress; fear for future; guilt; impact on daily organization; physical impact; impact on behaviour with hospitalized child; financial impact; disturbed breastfeeding; physical reaction of hospitalized child; impact on feeding of hospitalized child; impact on behaviour with other children; sibling's reaction. Scale ranges from 1 (not at all) to 4 (a lot). Higher scores indicate higher impact on parents.	Immediately at discharge from hospital