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)

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.

Study Overview

• Status: Completed
• Conditions: Surgical Operation With the Settle of a Redon's Drain
• Intervention / Treatment: Other: Relaxing-touch method

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87 042
    • Limoges hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Relaxing-touch method	Other: Relaxing-touch method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare, for 2 groups, the Score of pain: EVA scale (score 0-10).	Score of pain: EVA scale (score 0-10). The 2 groups average EVA level will be compared.	5 minutes
Percentage of children with a pain rating ≥ 4	The Percentage of children with a pain rating ≥ 4 will be compared between the two groups in children aged 7 to 11 and 12 to 17 years old	5 minutes
To compare, for 2 groups, the average level of EVA-anxiety scores	Comparison of the average level of "EVA-anxiety" scores in the two groups of children before treatment	5 minutes
Proportion of children with a pain level ≥ 4 during removal of the drain	the proportion of children with a pain level ≥ 4 during removal of the drain in the group of children who underwent an orthopedic procedure; a visceral act; an act thoracic; an act for gynecomastia; an act for burn treatment by prosthesis expansion;	5 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Laurent FOURCADE, MD, University Hospital of Limoges

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 26, 2014
• First Submitted That Met QC Criteria: January 26, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: I11017