- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02857114
Measuring the Effects of Touch Relaxation Painful Patients in Oncologie Nursing (ToucherDétente)
August 2, 2016 updated by: Assistance Publique Hopitaux De Marseille
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
104
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
-
-
-
Marseille, France, 13354
- Recruiting
- Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
-
Contact:
- Michelle GAIDE
- Phone Number: 0491382747
- Email: drci@ap-hm.fr
-
-
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:
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
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: 3 days
|
pain measurement by the scale numerical pain
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety
Time Frame: 3 days
|
measurement with the scale of COVI
|
3 days
|
|
consumption of analgesics
Time Frame: 3 days
|
daily creel analgesics and anxiolytics
|
3 days
|
|
wellness
Time Frame: 3 days
|
measure with the scale of edmonton
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2015
Primary Completion (Anticipated)
February 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
August 2, 2016
First Posted (Estimate)
August 5, 2016
Study Record Updates
Last Update Posted (Estimate)
August 5, 2016
Last Update Submitted That Met QC Criteria
August 2, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2014-20
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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