Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

Sponsor

University Hospital, Geneva (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06108648

Collaborator

(none)

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

200

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Drug: Lavender essential oil 10%, diluted in 90% olive oil Other: Control	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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

Active Comparator: Control

Standard care: supportive measures according to national standards.

Other: Control

Standard care according to national standards.

Outcome Measures

Primary Outcome Measures

Cough frequency [Up to 2 days]
Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)

Secondary Outcome Measures

Crying episodes [Up to 2 days]
Number of crying episodes noted by parents on crying calendar
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
Maximum oxygen supplementation [Immediately at discharge from hospital]
Maximum oxygen flow in L/min
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 11 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland	Fribourg		Switzerland	1708
2	Children's' Hospital, University Hospital of Geneva, Switzerland	Geneva		Switzerland	1211