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NCT Number: NCT06108648

Efficacy of Lavender Essential Oil Chest Wraps in Infants With Bronchiolitis

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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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Cough Infections Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinique de pediatrie, HFR Fribourg - Hopital cantonal, Switzerland, Fribourg, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Other

Standard care according to national standards.

Primary outcomes

  1. Cough frequency

    Time frame: Up to 2 days

    Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)

Secondary outcomes

  1. Crying episodes

    Time frame: Up to 2 days

    Number of crying episodes noted by parents on crying calendar

  2. Respiratory rate

    Time frame: Baseline, 1 hour, 4 hours

    Number of breaths per minute

  3. Oxygen supplementation requirement

    Time frame: Immediately at discharge from hospital

    Presence of oxygen supplementation during hospital stay (yes/no)

  4. Oxygen supplementation duration

    Time frame: Immediately at discharge from hospital

    Number of hours of oxygen supplementation

  5. Maximum oxygen supplementation

    Time frame: Immediately at discharge from hospital

    Maximum oxygen flow in L/min

  6. Hospital length of stay

    Time frame: Immediately at discharge from hospital

    Hospital length of stay in number of days, Geneva site only

  7. Parental satisfaction assessed with patient satisfaction questionnaire

    Time frame: 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.

  8. Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabiola Stollar, MD, PhD

CONTACT

[email protected]

+41795534380

Tido von Schoen-Angerer, MD, MPH

CONTACT

[email protected]

+41766159263

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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