Essential Oils on Anxiety of Patients Suffering From Cancer

NCT02835352 | Terminated

• 1 other identifier: 2014-AH-DOUL-SC
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of essential oils massage on anxiety of patients who are suffering from cancer at a metastasis stage. Half of patients will be massaged first by essential oils and then by oil only. The other half will be massaged first by oil and then by essential oils.

Conditions

Neoplasm Metastasis

Keywords

anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiolytic consumption

  Anxiolytic consumption will be assessed at day 7 at the end of each phase

  7 days

Study Arms (2)

Essential oils then oil massages

EXPERIMENTAL

Essential oils massages will be done as needed during a period of 7 days, then oïl massages as needed will be done during a follow-up period of 7 days

Other: Essential oils massages; Other: Oil massages

Oil then essential oils massages

EXPERIMENTAL

Oil massages will be done as needed during a period of 7 days, then essential oïl massages as needed will be done during a follow-up period of 7 days

Other: Essential oils massages; Other: Oil massages

Interventions

Essential oils massages OTHER

Essential oils then oil massages; Oil then essential oils massages

Oil massages OTHER

Essential oils then oil massages; Oil then essential oils massages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult suffering from cancer at a metastatic stage
• Life expectancy \> 15 days, assessed by investigator
• Hospitalized at the Chevrel unit from Centre Eugène Marquis, palliative unit care, for more than 15 days
• Regular anxiolytic treatment or imperative need to introduce anxiolytic treatment (assessed by investigator) within 48 hours following his hospitalization entry
• \> 18 years

You may not qualify if:

• Patient already recruited in a therapeutic trial
• Patient not covered by a social security system
• Pregnant or likely pregnant patient, breastfeeding patient
• Allergy to any component of essential oils mixture and vegetable oils : bitter orange petitgrain, fine lavender, ylang-ylang, macadamia
• Minors, people deprived of their liberty or protected people,
• Impaired cognitive functions making impossible to obtain informed consent

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre Eugène Marquis

Rennes, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Agnès Hutin, MD

  Centre Eugène Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 18, 2016
• Study Start: June 21, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)