Essential Oils on Anxiety of Patients Suffering From Cancer (RHECAP)

January 23, 2018 updated by: Center Eugene Marquis

Impact of Essential Oils on Anxiety of Patients Suffering From Metastasis Cancer - Feasibility Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
        • Centre Eugène Marquis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Essential oils then oil massages
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
Experimental: Oil then essential oils massages
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiolytic consumption
Time Frame: 7 days
Anxiolytic consumption will be assessed at day 7 at the end of each phase
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Agnès Hutin, MD, Centre Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-AH-DOUL-SC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not authorized by French law

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasm Metastasis

Clinical Trials on Essential oils massages

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe