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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender oil | Experimental | 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. |
|
| Control | Active Comparator | Standard care: supportive measures according to national standards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender essential oil 10%, diluted in 90% olive oil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cough frequency | Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc) | Up to 2 days |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabiola Stollar, MD, PhD | Contact | +41795534380 | Fabiola.stollar@hcuge.ch | |
| Tido von Schoen-Angerer, MD, MPH | Contact | +41766159263 | tido.von.schoenangerer@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Klara Posfay-Barbe, MD, PhD | Children's' Hospital, University Hospital of Geneva, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland | Recruiting | Fribourg | 1708 | Switzerland |
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.
Beginning 9 months and ending 36 months following article publication.
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.
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D003371 | Cough |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| C045718 | lavender oil |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Patients are randomized to receive standard care with additional lavender essential oil chest wrap during two nights of hospitalization or standard care alone.
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|
| Control | Other | Standard care according to national standards. |
|
| 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 |
| Children's' Hospital, University Hospital of Geneva, Switzerland | Recruiting | Geneva | 1211 | Switzerland |
|
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |