Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

Phase 4

Recruiting

• Conditions: Bronchiolitis
• Interventions: Other: Control; Drug: Lavender essential oil 10%, diluted in 90% olive oil

• Registration Number: NCT06108648
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-10-31
• Study Start: 2023-12-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-03-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Standard care: supportive measures according to national standards.
Lavender oil	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.

Primary Outcome Measures

Name	Time	Method
Cough frequency	Up to 2 days	Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)

Secondary Outcome Measures

Name	Time	Method
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
Oxygen supplementation requirement	Immediately at discharge from hospital	Presence of oxygen supplementation during hospital stay (yes/no)
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.
Respiratory rate	Baseline, 1 hour, 4 hours	Number of breaths per minute
Maximum oxygen supplementation	Immediately at discharge from hospital	Maximum oxygen flow in L/min
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.

Trial Locations

Locations (2)

Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland; 🇨🇭 Fribourg, Switzerland

Children's' Hospital, University Hospital of Geneva, Switzerland; 🇨🇭 Geneva, Switzerland