Surgical Operation With the Settle of a Redon's DrainTOUTETDOUNCT02047591
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.
A study testing Relaxing-touch method in people with Surgical Operation With the Settle of a Redon's Drain, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Surgical Operation With the Settle of a Redon's Drain
- What is being tested?
- Relaxing-touch method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Relaxing-touch method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxing-touch methodOther
| Study group | Role | What they receive |
|---|---|---|
| Relaxing-touch method | Experimental | Not described Receives: Other: Relaxing-touch method |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 minutes
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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;
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Operation With the Settle of a Redon's DrainStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent FOURCADE, MD, Principal investigator, University Hospital of Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047591
- Sponsor's protocol ID
- I11017
- Acronym
- TOUTETDOU
- Status last verified
- Feb 2016
- First submitted
- 26 Jan 2014
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Effectiveness of pain relief by
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02047591
- Acronym / sponsor ID
- TOUTETDOU / I11017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxing-touch method | Experimental | Other: Relaxing-touch method |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxing-touch method | Other | Relaxing-touch method |
Primary outcome
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)
4 secondary outcomes
To compare, for 2 groups, the Score of pain: EVA scale (score 0-10).
Time frame: 5 minutes
Percentage of children with a pain rating ≥ 4
Time frame: 5 minutes
To compare, for 2 groups, the average level of EVA-anxiety scores
Time frame: 5 minutes
Proportion of children with a pain level ≥ 4 during removal of the drain
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publicationEffectiveness of pain relief by
- Results of the researchLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent FOURCADE, MD principal investigator
University Hospital of Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxing-touch method in people with Surgical Operation With the Settle of a Redon's Drain, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the score of pain, just after the removal of the Redon's drain (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02047591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.