Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Drug: Lavender essential oil 10%, diluted in 90% olive oil; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fabiola Stollar, MD, PhD; Phone Number: +41795534380; Email: Fabiola.stollar@hcuge.ch
• Study Contact Backup: Name: Tido von Schoen-Angerer, MD, MPH; Phone Number: +41766159263; Email: tido.von.schoenangerer@gmail.com

Study Locations

• Switzerland
  • Fribourg, Switzerland, 1708
    • Recruiting
    • Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland
    • Contact: Benedikt Huber, MD; Phone Number: +4126426711; Email: Benedikt.Huber@h-fr.ch
  • Geneva, Switzerland, 1211
    • Recruiting
    • Children's' Hospital, University Hospital of Geneva, Switzerland
    • Contact: Fabiola Stollar, MD, PhD; Phone Number: +41795534380; Email: Fabiola.stollar@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lavender 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.	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.
Active Comparator: Control; Standard care: supportive measures according to national standards.	Other: Control; Standard care according to national standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough frequency	Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)	Up to 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying episodes	Number of crying episodes noted by parents on crying calendar	Up to 2 days
Respiratory rate	Number of breaths per minute	Baseline, 1 hour, 4 hours
Oxygen supplementation requirement	Presence of oxygen supplementation during hospital stay (yes/no)	Immediately at discharge from hospital
Oxygen supplementation duration	Number of hours of oxygen supplementation	Immediately at discharge from hospital
Maximum oxygen supplementation	Maximum oxygen flow in L/min	Immediately at discharge from hospital
Hospital length of stay	Hospital length of stay in number of days, Geneva site only	Immediately at discharge from hospital
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Study Director: Klara Posfay-Barbe, MD, PhD, Children's' Hospital, University Hospital of Geneva, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: complementary therapies; infant; cough; bronchiolitis; essential oil; lavendula
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 2022-01116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with the Geneva University Hospitals HUG.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigator who has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with the Geneva University Hospitals HUG.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No