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.

NCT02047591 | Completed

• 1 other identifier: I11017
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Operation With the Settle of a Redon's Drain

Outcome Measures

Primary Outcomes (1)

• To compare the score of pain, just after the removal of the Redon's drain

  The score of pain, just after the removal of the Redon's drain, constitutes the main end point. It will be collected by the score of the EVA (scores from 0 to 10)

  5 minutes

Secondary Outcomes (4)

• To compare, for 2 groups, the Score of pain: EVA scale (score 0-10).

  5 minutes

• Percentage of children with a pain rating ≥ 4

  5 minutes

• To compare, for 2 groups, the average level of EVA-anxiety scores

  5 minutes

• Proportion of children with a pain level ≥ 4 during removal of the drain

  5 minutes

Study Arms (2)

Relaxing-touch method

EXPERIMENTAL

Other: Relaxing-touch method

Usual care

NO INTERVENTION

Interventions

Relaxing-touch method OTHER

Relaxing-touch method

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges Hospital

Limoges, 87 042, France

Location

Related Publications (1)

• Effectiveness of pain relief by

  RESULT

Related Links

• Results of the research

Study Officials

• Laurent FOURCADE, MD

  University Hospital of Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 28, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 27, 2026

Record last verified: 2016-02

Locations

FR (1)