Procedural PainPEACE-HYPNONCT06373627
Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
A study testing Hypnosis, Conventional medications used for sedation-analgesia and Medications used in addition to hypnosis in people with Procedural Pain and Congenital Heart Disease, run by Fondation Hôpital Saint-Joseph.
Trial summary
The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Procedural Pain, Congenital Heart Disease, Heart Surgery
- What is being tested?
- Hypnosis, Conventional medications used for sedation-analgesia and Medications used in addition to hypnosis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2024to 3 May 2025
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged ⩾ 6 years and <18 years.
- Postoperative cardiac surgery patients with intrathoracic drains (pleural or mediastinal).
- Patients affiliated with or benefiting from a social security or similar scheme.
- Oral consent obtained from minor children
- Written consent from the minor's legal representatives
Who cannot join
- Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain
- Absence of at least 1 legal representative of the minor child
- French not understood
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.
The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.
Read the detailed description
Pain and anxiety are common in children with congenital heart disease. They are at risk to develop impaired pain signal processing, and tolerance to opioids and benzodiazepines due to repeated exposure.
Removal of thoracic drains is a standard procedure following cardiac surgery in patients with congenital heart disease. This procedure is usually performed after multimodal sedation-analgesia (intraveinous and inhalation drugs). However, the drugs used (ketamine and midazolam) can have significant side-effects, such as respiratory and circulatory depression.
A few studies have shown the efficacy of therapeutic hypnosis and distractive methods in children, but with a low level of evidence, unlike in adults.
However, none of these studies has evaluated therapeutic hypnosis in children with congenital heart disease.
Hypnosis would be an additional way of better controlling procedural pain, without the side effects of medication. This would reduce the dose of analgesic drugs and improve the pain experience.
The aim of PEACE-Hypno is to evaluate therapeutic hypnosis as a co-analgesic way of thoracic drain removal in children with congenital heart disease.
- Conditions
- Procedural Pain, Congenital Heart Disease, Heart Surgery, Hypnosis
- Being tested
- Hypnosis, Conventional medications used for sedation-analgesia, Medications used in addition to hypnosis
- Keywords
- Congenital Heart Disease, Procedural Pain, Intrathoracic drain, Hypnosis, Pain controlled, Heart surgery
- Medical subject headings
- Pain, Procedural, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
A hypnosis session takes place in 3 stages:
- An induction stage, where we move from an ordinary state of consciousness to a modified state of consciousness through dissociation.
- A work phase to deepen the hypnotic trance. This phase is fueled by the construction of suggestions and metaphors, analogous to those of the patient in pain.
- Finally, a return to the ordinary state of consciousness through re-association with the patient.
Conventional medications used for sedation-analgesiaDrug
MEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg)
Medications used in addition to hypnosisDrug
MEOPA + intravenous ketamine (0.3 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | Hypnosis + MEOPA + direct intravenous Ketamine (0.3 mg/kg) In the event of insufficient analgesia or failure of hypnosis, a 2nd dose of ketamine (0.3 mg/kg) may be administered. Receives: Other: Hypnosis; Drug: Medications used in addition to hypnosis |
| Conventional sedation-analgesia | Active comparator | MEOPA + direct intravenous Ketamine (0.5 mg/kg) + direct intravenous Midazolam (50 µg/kg) In accordance with current service protocol. Receives: Drug: Conventional medications used for sedation-analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome : Pain evaluation by VAS self-assessment
The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia does not change level of pain generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6 to 18 years with congenital heart disease, self-assessed by VAS.
Measured: VAS will be measured 5 minutes before the start of the procedure (T0) and at the end of the procedure (T1) to assess the average pain intensity during drain removal.
Secondary outcomes (5)
Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal
The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia generates non-inferior pain to that generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6-18 years with congenital heart disease, in hetero-assessment by FLACC by a blinded assigning arm assessor.
Measured: Scoring of the FLACC scale by the evaluator through study completion (up to1 year), blinded to the allocation arm, based on the video recorded during the procedure.
Maximum heart rate
Comparison between the two groups of the maximum heart rate during intrathoracic drain removal, measured continuously on a monitor.
Measured: The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
Cumulative doses of intravenous analgesics
Comparison between the two groups of the cumulative doses of Ketamine and Midazolam used during the procedure.
Measured: Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
Respiratory depression
Comparison between the two groups of the number of episodes of respiratory depression corresponding to a respiratory rate of less than 10/min, measured continuously using the scope.
Measured: The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.
Parental satisfaction using Visual Analogic Scale (VAS)
Parents evaluate their satisfaction about the procedure, using a VAS self-assessment.
Measured: Parents evaluate their satisfaction the day after the procedure (D+1), with a minimal value of 0/10 (e.g no satisfaction), and a maximal value of 10/10 (maximal satisfaction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start2 May 2024 (estimated)
- Primary completion2 May 2025 (estimated)
- Study completion3 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard CHAMBON, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373627
- Sponsor's protocol ID
- 2024-A00534-43
- Acronym
- PEACE-HYPNO
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B. The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615.
PubMed 29912070Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5.
PubMed 16517277Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.
PubMed 30284240Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.
PubMed 19255840Geagea D, Tyack Z, Kimble R, Polito V, Ayoub B, Terhune DB, Griffin B. Clinical Hypnosis for Procedural Pain and Distress in Children: A Scoping Review. Pain Med. 2023 Jun 1;24(6):661-702. doi: 10.1093/pm/pnac186.
PubMed 36448690Chester SJ, Stockton K, De Young A, Kipping B, Tyack Z, Griffin B, Chester RL, Kimble RM. Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):223. doi: 10.1186/s13063-016-1346-9.
PubMed 27129580Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.
PubMed 16777328Rodrigues VBM, Costa LR, Correa de Faria P. Parents' satisfaction with paediatric dental treatment under sedation: A cross-sectional study. Int J Paediatr Dent. 2021 May;31(3):337-343. doi: 10.1111/ipd.12661. Epub 2020 Jun 21.
PubMed 32412090Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015 Nov;156(11):2132-2151. doi: 10.1097/j.pain.0000000000000305.
PubMed 26207651Crellin D, Harrison D, Santamaria N, Babl FE. Comparison of the Psychometric Properties of the FLACC Scale, the MBPS and the Observer Applied Visual Analogue Scale Used to Assess Procedural Pain. J Pain Res. 2021 Mar 31;14:881-892. doi: 10.2147/JPR.S267839. eCollection 2021.
PubMed 33833566Abdolkarimi B, Zareifar S, Golestani Eraghi M, Saleh F. Comparison Effect of Intravenous Ketamine with Pethidine for Analgesia and Sedation during Bone Marrow Procedures in Oncologic Children: A Randomized, Double-Blinded, Crossover Trial. Int J Hematol Oncol Stem Cell Res. 2016 Oct 1;10(4):206-211.
PubMed 27928474Chiaretti A, Ruggiero A, Barbi E, Pierri F, Maurizi P, Fantacci C, Bersani G, Riccardi R. Comparison of propofol versus propofol-ketamine combination in pediatric oncologic procedures performed by non-anesthesiologists. Pediatr Blood Cancer. 2011 Dec 15;57(7):1163-7. doi: 10.1002/pbc.23170. Epub 2011 May 16.
PubMed 21584935Rayala S, Kyander M, Haridass V, Palat G, Strom A, Wiebe T, Brun E, Segerlantz M. Low-dose Oral Ketamine as a Procedural Analgesia in Pediatric Cancer Patients Undergoing Bone Marrow Aspirations at a Resource-limited Cancer Hospital in India. Indian J Palliat Care. 2019 Oct-Dec;25(4):501-507. doi: 10.4103/IJPC.IJPC_110_19.
PubMed 31673202Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.
PubMed 28186223Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.
PubMed 27683581
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease: a Randomized Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT06373627
- Acronym / sponsor ID
- PEACE-HYPNO / 2024-A00534-43
- Conditions
- Procedural Pain, Congenital Heart Disease, Heart Surgery, Hypnosis
- Keywords
- Congenital Heart Disease, Procedural Pain, Intrathoracic drain, Hypnosis, Pain controlled, Heart surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 3 May 2025 (estimated)
- First posted
- 18 Apr 2024 (actual)
- 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 aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.
Detailed description
Pain and anxiety are common in children with congenital heart disease. They are at risk to develop impaired pain signal processing, and tolerance to opioids and benzodiazepines due to repeated exposure.
Removal of thoracic drains is a standard procedure following cardiac surgery in patients with congenital heart disease. This procedure is usually performed after multimodal sedation-analgesia (intraveinous and inhalation drugs). However, the drugs used (ketamine and midazolam) can have significant side-effects, such as respiratory and circulatory depression.
A few studies have shown the efficacy of therapeutic hypnosis and distractive methods in children, but with a low level of evidence, unlike in adults.
However, none of these studies has evaluated therapeutic hypnosis in children with congenital heart disease.
Hypnosis would be an additional way of better controlling procedural pain, without the side effects of medication. This would reduce the dose of analgesic drugs and improve the pain experience.
The aim of PEACE-Hypno is to evaluate therapeutic hypnosis as a co-analgesic way of thoracic drain removal in children with congenital heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Other: Hypnosis, Drug: Medications used in addition to hypnosisHypnosis + MEOPA + direct intravenous Ketamine (0.3 mg/kg) In the event of insufficient analgesia or failure of hypnosis, a 2nd dose of ketamine (0.3 mg/kg) may be administered. |
| Conventional sedation-analgesia | Active comparator | Drug: Conventional medications used for sedation-analgesiaMEOPA + direct intravenous Ketamine (0.5 mg/kg) + direct intravenous Midazolam (50 µg/kg) In accordance with current service protocol. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged ⩾ 6 years and <18 years.
- Postoperative cardiac surgery patients with intrathoracic drains (pleural or mediastinal).
- Patients affiliated with or benefiting from a social security or similar scheme.
- Oral consent obtained from minor children
- Written consent from the minor's legal representatives
Key exclusion criteria (3 listed)
- Psychomotor retardation, cognitive/psychiatric impairment preventing self-assessment of pain
- Absence of at least 1 legal representative of the minor child
- French not understood
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 |
|---|---|---|
| HypnosisA hypnosis session takes place in 3 stages: * An induction stage, where we move from an ordinary state of consciousness to a modified state of consciousness through dissociation. * A work phase to deepen the hypnotic trance. This phase is fueled by the construction of suggestions and metaphors, analogous to those of the patient in pain. * Finally, a return to the ordinary state of consciousness through re-association with the patient. | Other | Hypnosis |
| Conventional medications used for sedation-analgesiaMEOPA + intravenous ketamine (0.5 mg/kg) + intraveinous midazolam (50µg/kg) | Drug | Conventional sedation-analgesia |
| Medications used in addition to hypnosisMEOPA + intravenous ketamine (0.3 mg/kg) | Drug | Hypnosis |
Primary outcome
Primary Outcome : Pain evaluation by VAS self-assessment
Time frame: VAS will be measured 5 minutes before the start of the procedure (T0) and at the end of the procedure (T1) to assess the average pain intensity during drain removal.
The use of therapeutic hypnosis in addition to a minimal effective dose of intravenous and inhaled sedation-analgesia does not change level of pain generated by conventional sedation-analgesia during intrathoracic drain removal in children aged 6 to 18 years with congenital heart disease, self-assessed by VAS.
5 secondary outcomes
Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal
Time frame: Scoring of the FLACC scale by the evaluator through study completion (up to1 year), blinded to the allocation arm, based on the video recorded during the procedure.
Maximum heart rate
Time frame: The maximum heart rate is measured during the intrathoracic drain removal, through the beginning to the end of procedure
Cumulative doses of intravenous analgesics
Time frame: Cumulative doses of intravenous analgesics refer to drugs administered from the beginning to the end of the procedure.
Respiratory depression
Time frame: The number of respiratory depression is measured during the intrathoracic drain removal, through the beginning to the end of procedure.
Parental satisfaction using Visual Analogic Scale (VAS)
Time frame: Parents evaluate their satisfaction the day after the procedure (D+1), with a minimal value of 0/10 (e.g no satisfaction), and a maximal value of 10/10 (maximal satisfaction)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 29912070Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B. The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615.
- Background: PubMed 16517277Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5.
- Background: PubMed 30284240Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.
- Background: PubMed 19255840Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.
- Background: PubMed 36448690Geagea D, Tyack Z, Kimble R, Polito V, Ayoub B, Terhune DB, Griffin B. Clinical Hypnosis for Procedural Pain and Distress in Children: A Scoping Review. Pain Med. 2023 Jun 1;24(6):661-702. doi: 10.1093/pm/pnac186.
- Background: PubMed 27129580Chester SJ, Stockton K, De Young A, Kipping B, Tyack Z, Griffin B, Chester RL, Kimble RM. Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):223. doi: 10.1186/s13063-016-1346-9.
- Background: PubMed 16777328Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.
- Background: PubMed 32412090Rodrigues VBM, Costa LR, Correa de Faria P. Parents' satisfaction with paediatric dental treatment under sedation: A cross-sectional study. Int J Paediatr Dent. 2021 May;31(3):337-343. doi: 10.1111/ipd.12661. Epub 2020 Jun 21.
- Background: PubMed 26207651Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015 Nov;156(11):2132-2151. doi: 10.1097/j.pain.0000000000000305.
- Background: PubMed 33833566Crellin D, Harrison D, Santamaria N, Babl FE. Comparison of the Psychometric Properties of the FLACC Scale, the MBPS and the Observer Applied Visual Analogue Scale Used to Assess Procedural Pain. J Pain Res. 2021 Mar 31;14:881-892. doi: 10.2147/JPR.S267839. eCollection 2021.
- Background: PubMed 27928474Abdolkarimi B, Zareifar S, Golestani Eraghi M, Saleh F. Comparison Effect of Intravenous Ketamine with Pethidine for Analgesia and Sedation during Bone Marrow Procedures in Oncologic Children: A Randomized, Double-Blinded, Crossover Trial. Int J Hematol Oncol Stem Cell Res. 2016 Oct 1;10(4):206-211.
- Background: PubMed 21584935Chiaretti A, Ruggiero A, Barbi E, Pierri F, Maurizi P, Fantacci C, Bersani G, Riccardi R. Comparison of propofol versus propofol-ketamine combination in pediatric oncologic procedures performed by non-anesthesiologists. Pediatr Blood Cancer. 2011 Dec 15;57(7):1163-7. doi: 10.1002/pbc.23170. Epub 2011 May 16.
- Individual participant dataSharing planned: No
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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.
Edouard CHAMBON principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis, Conventional medications used for sedation-analgesia and Medications used in addition to hypnosis in people with Procedural Pain and Congenital Heart Disease, run by Fondation Hôpital Saint-Joseph.
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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie GERARD (0672510756, mariegerard@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome : Pain evaluation by VAS self-assessment (time frame: VAS will be measured 5 minutes before the start of the procedure (T0) and at the end of the procedure (T1) to assess the average pain intensity during drain removal.). 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 NCT06373627, which also lists 19 linked publications.
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 18 Apr 2024.