Bronchiolitis
Conditions
Keywords
bronchiolitis, infant, cough, essential oil, lavendula, complementary therapies
Brief 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.
Interventions
DRUGLavender 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.
OTHERControl
Standard care according to national standards.
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 11 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough frequency | Up to 2 days | Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | Baseline, 1 hour, 4 hours | Number of breaths per minute |
| Oxygen supplementation requirement | Immediately at discharge from hospital | Presence of oxygen supplementation during hospital stay (yes/no) |
| Oxygen supplementation duration | Immediately at discharge from hospital | Number of hours of oxygen supplementation |
| Crying episodes | Up to 2 days | Number of crying episodes noted by parents on crying calendar |
| Hospital length of stay | Immediately at discharge from hospital | Hospital length of stay in number of days, Geneva site only |
| Parental satisfaction assessed with patient satisfaction questionnaire | Immediately at discharge from hospital | 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. |
| Impact on parents assessed by the Impact of Bronchiolitis Hospitalization Questionnaire (IBHQ) | Immediately at discharge from hospital | 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. |
| Maximum oxygen supplementation | Immediately at discharge from hospital | Maximum oxygen flow in L/min |
Countries
Switzerland
Contacts
Primary ContactFabiola Stollar, MD, PhD
Backup ContactTido von Schoen-Angerer, MD, MPH
Outcome results
None listed