Anthropological Survey on the Use of Essential Oils (EOs) by Cystic Fibrosis Patients: a Quantitative and Qualitative Approach (AROMA)

Patients and parents of patients will be asked to answer a questionnaire on paper or online, by the CRCMs and through communication campaigns distributed by the association Vaincre La Mucoviscidose (VLM).

This questionnaire includes about fifty items that will take 5 to 12 minutes to complete. The study aims to interview 250 patients / parents of patients, users and non-users of essential oils.

Thirty patients or volunteer parents will then meet with a health anthropologist for qualitative interviews to document very precisely the modalities of use of essential oils: which ones, at what dose, advised by whom, the dedicated budget. Relationships with CRCM doctors, the effects felt, the side effects will also be explored.

The global data of the two phases will be integrated and put into perspective with the scientific data currently available on essential oils.

Study Overview

• Status: Unknown
• Conditions: Mucoviscidosis

• Study Type: Observational
• Enrollment (Anticipated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cystic fibrosis patient

Description

Inclusion Criteria:

• Cystic fibrosis patient or parent of a child with cystic fibrosis

Exclusion Criteria:

• patient who refused

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of use of the different EO by the patients who answered the questionnaire	Frequency of use of the different EO by the patients who answered the questionnaire	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (ACTUAL): November 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis
• Other Study ID Numbers: 38RC20.303; 2020-A02375-34 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No