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出境医 / 临床实验 / The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) (PAPS)
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) (PAPS)
Study Description
Brief Summary:
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Premature Infant | Other: Installation of a naso-gastric feeding tube | Not Applicable |
Detailed Description:
Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain.
Several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals.
Neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure.
In cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother. |
| Actual Study Start Date : | November 15, 2019 |
| Estimated Primary Completion Date : | November 15, 2021 |
| Estimated Study Completion Date : | July 1, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Skin-to-skin support
The newborn is dressed in one layer of clothing with a hat, he is placed in the ventral position directly on the mother's chest, covered with a warm blanket and held in place with a band during the insertion of the naso-gastric feeding tube.
|
Other: Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
|
|
Holding
The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.
|
Other: Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
|
|
Four hands care
Carried out by two professionals: one health-care professional supports the child and helps stabilize the newborn whilst the other professional inserts the naso-gastric feeding tube.
|
Other: Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
|
|
Containing support with equipment
Carried out by one healthcare Professional, who places the newborn in such a manner that he will be held in the optimum position (using a soft sheet) during the insertion of the naso-gastric feeding tube.
|
Other: Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
|
Outcome Measures
Primary Outcome Measures :
- Pain during insertion of the probe [ Time Frame: Day 1 ]Evaluation of the newborn's pain during insertion of the naso-gastric tube using the Premature Infant Pain Profile (PIPP) scale. The PIPP consists of 3 behavioral (facial actions: brow bulge, eye squeeze, and nasolabial furrow) and 2 physiological (heart rate and oxygen saturation) indicators, and 2 contextual [gestational age (GA) and behavioral state] variables that modify pain. In the same time, the heart rate and oxygen saturation of the newborns were measured using a pulse oximeter.
Secondary Outcome Measures :
- Evaluation of pain using the DAN scale [ Time Frame: Day 1 ]This scale scores pain from 0 to 10, where 0 is no pain and 10 is maximum pain; it evaluates three items: facial expressions, limb movements and vocal expression.
- Maternal satisfaction [ Time Frame: Day 1 ]Mother's satisfaction with regards to her involvement in the procedure. The questions are about her sense of usefulness during the probe, her knowledge of child's reaction and her desire to repeat the experience.
- Professional's satisfaction [ Time Frame: Day 1 ]Health carers satisfaction during the procedure. The questions are about his appreciation of the effective management of the pain, the ease of installation, the benefits of the mother's presence and his desire to repeat the experience.
- Duration of the Naso -gastric tube in situ [ Time Frame: Day 7 ]Lifetime of the probe after insertion
- Procedure time [ Time Frame: Day 1 ]Time taken to insert the naso-gatric tube
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days
- Prescription of enteral nutrition via naso-gastric tube
- Naso-gastric tube in-situ
- Informed consent of both parents
Exclusion Criteria:
For the newborn
- Under respiratory assistance
- With nasal or buccal malformation
- With abnormal heart rhythm or congenital heart disease
- With hemodynamic instability
- Transfer to type 3 neonatal unit
- With a DAN score > 0 before treatment
- With an umbilical venous catheter in-situ
- Fed with thickened milk
- Prescription of analgesic medications
For the parents
- Minor
- Under legal protection
- Difficulties which do not permit the mother to carry out skin-to skin contact or holding support
Contacts and Locations
Contacts
| Contact: Maryse Chtourbine, Mrs | 387345265 ext 0033 | m.chtourbine@chr-metz-thionville.fr | |
| Contact: Patrick Pinaud, MD | 387553449 ext 0033 | p.pinaud@chr-metz-thionville.fr |
Locations
| France | |
| CHR Metz Thionville | Recruiting |
| Metz, France, 57085 | |
| Contact: Nadia OUAMARA 387557750 ext 0033 projet-recherche@chr-metz-thionville.fr | |
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 30, 2019 | ||||||||
| First Posted Date ICMJE | May 6, 2019 | ||||||||
| Last Update Posted Date | May 3, 2021 | ||||||||
| Actual Study Start Date ICMJE | November 15, 2019 | ||||||||
| Estimated Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain during insertion of the probe [ Time Frame: Day 1 ] Evaluation of the newborn's pain during insertion of the naso-gastric tube using the Premature Infant Pain Profile (PIPP) scale. The PIPP consists of 3 behavioral (facial actions: brow bulge, eye squeeze, and nasolabial furrow) and 2 physiological (heart rate and oxygen saturation) indicators, and 2 contextual [gestational age (GA) and behavioral state] variables that modify pain. In the same time, the heart rate and oxygen saturation of the newborns were measured using a pulse oximeter.
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) | ||||||||
| Official Title ICMJE | The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother. | ||||||||
| Brief Summary | Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion. | ||||||||
| Detailed Description |
Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain. Several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals. Neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure. In cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Premature Infant | ||||||||
| Intervention ICMJE | Other: Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2022 | ||||||||
| Estimated Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: For the newborn
For the parents
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03939169 | ||||||||
| Other Study ID Numbers ICMJE | 2016-07-CHRMT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Centre Hospitalier Régional Metz-Thionville | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Régional Metz-Thionville | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Centre Hospitalier Régional Metz-Thionville | ||||||||
| Verification Date | July 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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