Back to resultsThe Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) (PAPS)
Primary Purpose
Premature Infant
Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Installation of a naso-gastric feeding tube
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Infant focused on measuring pain, naso-gastric tube
Eligibility 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
Sites / Locations
- CHR Metz Thionville
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Skin-to-skin support
Holding
Four hands care
Containing support with equipment
Arm Description
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.
The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.
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.
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.
Outcomes
Primary Outcome Measures
Pain during insertion of the probe
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
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
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
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
Lifetime of the probe after insertion
Procedure time
Time taken to insert the naso-gatric tube
Full Information
NCT ID
NCT03939169
First Posted
April 30, 2019
Last Updated
December 1, 2022
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT03939169
Brief Title
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
Acronym
PAPS
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Suspended
Why Stopped
Pending CPP validation for an extension of the study
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant
Keywords
pain, naso-gastric tube
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skin-to-skin support
Arm Type
Other
Arm Description
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.
Arm Title
Holding
Arm Type
Other
Arm Description
The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.
Arm Title
Four hands care
Arm Type
Other
Arm Description
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.
Arm Title
Containing support with equipment
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Installation of a naso-gastric feeding tube
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain during insertion of the probe
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Evaluation of pain using the DAN scale
Description
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.
Time Frame
Day 1
Title
Maternal satisfaction
Description
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.
Time Frame
Day 1
Title
Professional's satisfaction
Description
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.
Time Frame
Day 1
Title
Duration of the Naso -gastric tube in situ
Description
Lifetime of the probe after insertion
Time Frame
Day 7
Title
Procedure time
Description
Time taken to insert the naso-gatric tube
Time Frame
Day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHR Metz Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
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