Impact of Multisensory Hand Massage on the Well-being of Cancer Patients (ONCOTACT)

November 22, 2022 updated by: Centre Hospitalier Universitaire de Nīmes
The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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
      • Nîmes, France, 30029
        • CHU de Nîmes

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:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient treated in the oncology department of CHU Nimes for any form of cancer with an EValuation Immédiate du Bien-Etre (EVIBE) score of 3 or lower

Exclusion Criteria:

  • The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient allergic to the massage oil
  • Patients with visual or auditory problems
  • Patients with an infection resulting in hyperthermia
  • Patient with hematoma on the hand
  • Patient with dermatological problems or painful areas on the hands
  • Patients with an EVIBE score greater than 3

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Multisensory massage
Other: Mulstisensory massage
7 minutes of hand massage followed by multisensory immersion (lights and music) for 23 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in well-being following multisensory massage
Time Frame: 30 minutes
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well-being following multisensory massage
Time Frame: 2 hours
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
2 hours
Well-being following multisensory massage
Time Frame: 4 hours
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
4 hours
Well-being following multisensory massage
Time Frame: 6 hours
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
6 hours
Well-being following multisensory massage
Time Frame: 8 hours
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
8 hours
Patient anxiety
Time Frame: Immediately prior to treatment
State Trait Anxiety Inventory (STAI)
Immediately prior to treatment
Patient anxiety
Time Frame: 30 minutes
State Trait Anxiety Inventory (STAI)
30 minutes
Patient anxiety
Time Frame: 8 hours
State Trait Anxiety Inventory (STAI)
8 hours
Satisfaction of staff performing the multisensory massage
Time Frame: End of inclusions (12 months)
Custom-built questionnaire; 11 questions on satisfaction at work on a 10-point scale (not at all - enormously)
End of inclusions (12 months)

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Nadine Houede, MD, CHU Nîmes

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)

September 17, 2019

Primary Completion (Actual)

October 11, 2022

Study Completion (Actual)

October 11, 2022

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • APIRES/2018/IP-01

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

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.

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