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

Cancer Clinical Trial

— ONCOTACT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03946397
• Other study ID #: APIRES/2018/IP-01
• Status: Terminated
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: October 11, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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