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Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery. (TOUTETDOU)

U

University of Limoges (UL)

Status

Completed

Conditions

Surgical Operation With the Settle of a Redon's Drain

Treatments

Other: Relaxing-touch method

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The 3rd governmental plan of fighting against the pain favored the development and the evaluation of the efficiency of the non pharmacological methods. Its results always showes a lack of knowledge of these methods and the utility to pursue the researches.

In the department of pediatric surgery of the university hospital of Limoges, the relaxing-touch is one of these methods which is more and more used. The healthcare staff noticed the beneficial effects of such an empirical method in terms of comfort and quality of life for the children.

In 2011, a pilot study led in this department showed that, in spite of the usual treatment, the removal of the Redon's drain remains painful for 25 % of the children (score on the pain scale > or = 4). This result convinced the medical team to write a protocol of research from the following hypothesis: the implementation of a protocol of the Redon's drain removal associated to the relaxing touch and usual treatment could lead to a decrease of the acute pain for a 7 to 17 years old child.

Enrollment

232 patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children > or = 7 and < 18 years old
  • Hospitalization for surgery having required the settle of a Redon's drain during surgery.
  • The presence of at least one of the legal representatives with the child during the care.
  • The consent of at least one of the legal representatives and agreement of the child for the relaxing-touch method.
  • The affiliation of one of the legal guardian to the social security.

Exclusion criteria

  • Children with an intellectual deficiency preventing the use of the scale EVA from the pain.
  • Children having already had one or several removal of the Redon's drain: the negative memory of the pain for a similar act could falsify the score of pain
  • Children refusing the usual care of the pain in the department by the MEOPA.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

232 participants in 2 patient groups

Relaxing-touch method
Experimental group
Treatment:
Other: Relaxing-touch method
Usual care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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