NCT03946397

Brief Summary

The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

November 28, 2022

Status Verified

September 1, 2022

Enrollment Period

3.1 years

First QC Date

May 9, 2019

Last Update Submit

November 22, 2022

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in well-being following multisensory massage

    EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest

    30 minutes

Secondary Outcomes (8)

  • Well-being following multisensory massage

    2 hours

  • Well-being following multisensory massage

    4 hours

  • Well-being following multisensory massage

    6 hours

  • Well-being following multisensory massage

    8 hours

  • Patient anxiety

    Immediately prior to treatment

  • +3 more secondary outcomes

Study Arms (2)

Multisensory massage

EXPERIMENTAL
Other: Mulstisensory massage

Control

NO INTERVENTION

Interventions

Mulstisensory massageOTHER

7 minutes of hand massage followed by multisensory immersion (lights and music) for 23 minutes

Multisensory massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nadine Houede, MD

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 10, 2019

Study Start

September 17, 2019

Primary Completion

October 11, 2022

Study Completion

October 11, 2022

Last Updated

November 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)