Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: Lavender essential oil 10%, diluted in 90% olive oil
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to receive standard care with additional lavender essential oil chest wrap during two nights of hospitalization or standard care alone.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender oil<br>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<br>* 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.<br>|
| Active Comparator: Control<br>Standard care: supportive measures according to national standards. | Other: Control<br>* Standard care according to national standards.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, infant, cough, essential oil, lavendula, complementary therapies