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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery

NCT07062133

Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome

NOT_YET_RECRUITING NA

Guided Distraction Movement

NCT07248852

Venipuncture Pain

NOT_YET_RECRUITING NA

The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit

NCT06390007

Pain, Postoperative Pediatric Disorder Acupuncture +2 more

COMPLETED NA

Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery

NCT03773198

Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb

COMPLETED PHASE3

Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor

NCT01600495

Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Operation With the Settle of a Redon's Drain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Relaxing-touch method

Group Type EXPERIMENTAL

Relaxing-touch method

Intervention Type OTHER

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Relaxing-touch method

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No