NCT02857114

Brief Summary

Measure the impact of touch relaxation on pain communicative patients suffering from chronic pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety welfare and consumption of analgesics

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

July 29, 2016

Last Update Submit

August 2, 2016

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Pain

    pain measurement by the scale numerical pain

    3 days

Secondary Outcomes (3)

  • anxiety

    3 days

  • consumption of analgesics

    3 days

  • wellness

    3 days

Study Arms (1)

massage

OTHER
Other: massage

Interventions

massageOTHER
massage

Eligibility Criteria

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

You may qualify if:

  • hospitalized in the oncology department at least 3 days
  • presenting the cancerous type of pain caused by their disease or treatment
  • numerical scale pain score = 4/10
  • receiving weak and strong opioids
  • platelet count\> 100
  • can receive anxiolytic
  • adult
  • Patient of both sexes
  • no other relaxation approaches

You may not qualify if:

  • against indication to touch: wound, bruises, circulatory disorders, diseases psychiatiques
  • risk of hematoma
  • numerical scale pain score \< 4/10
  • understanding of the difficulties of the French language
  • no receiving weak and strong opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Michelle GAIDE

CONTACT

04 91 38 27 47drci@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 5, 2016

Study Start

February 1, 2015

Primary Completion

February 1, 2018

Study Completion

December 1, 2018

Last Updated

August 5, 2016

Record last verified: 2016-07

Locations

FR(1)