Measuring the Effects of Touch Relaxation Painful Patient... | NCT02857114

Studies
Measuring the Effects of Touch Relaxation Painful Patients in Oncologie Nursing

NCT02857114

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Aug 5, 2016Estimated

Enrollment

104Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

massage

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Feb 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 29, 2016

First Submission Date that Met QC Criteria

Aug 2, 2016

First Posted Date

Aug 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2016

Last Update Posted Date

Aug 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Label	Type	Description	Intervention Names
massage	Other		Other: massage

Name	Type	Description	Arm Group Labels	Other Names
massage	Other		massage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	pain measurement by the scale numerical pain	3 days

Secondary Outcomes

Measure	Description	Time Frame
anxiety	measurement with the scale of COVI	3 days
consumption of analgesics	daily creel analgesics and anxiolytics	3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michelle GAIDE	Contact	04 91 38 27 47		drci@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Urielle DESALBRES	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille	Recruiting	Marseille		13354	France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided