Completed

NCT Number: NCT02047591

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.

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.

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Key information

Conditions

Surgical Operation With the Settle of a Redon's Drain

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges Hospital

Limoges, 87 042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relaxing-touch method

Other

Primary outcomes

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

Time frame: 5 minutes

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)

Secondary outcomes

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

Time frame: 5 minutes

Score of pain: EVA scale (score 0-10). The 2 groups average EVA level will be compared.
Percentage of children with a pain rating ≥ 4

Time frame: 5 minutes

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

Time frame: 5 minutes

Comparison of the average level of "EVA-anxiety" scores in the two groups of children before treatment
Proportion of children with a pain level ≥ 4 during removal of the drain

Time frame: 5 minutes

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;

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: TOUTETDOU

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2019
First posted: Jan 28, 2014
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.