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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02857114
Other study ID # 2014-20
Secondary ID
Status Recruiting
Phase N/A
First received July 29, 2016
Last updated August 2, 2016
Start date February 2015
Est. completion date December 2018

Study information

Verified date July 2016
Source Assistance Publique Hopitaux De Marseille
Contact Michelle GAIDE
Phone 04 91 38 27 47
Email drci@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 104
Est. completion date December 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
massage


Locations

Country Name City State
France Hôpital de la Timone Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain pain measurement by the scale numerical pain 3 days No
Secondary anxiety measurement with the scale of COVI 3 days No
Secondary consumption of analgesics daily creel analgesics and anxiolytics 3 days No
Secondary wellness measure with the scale of edmonton 3 days No
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