PainNCT03421158
Non-pharmacological Analgesic Effects on Term Newborns
A study testing breastfeeding, oral sucrose and Skin-to-Skin contact in people with Pain and Breast Feeding, run by Stanford University.
Trial summary
The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure. Read more about this study
- Who is it for?
- Ages 24 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Pain, Breast Feeding
- What is being tested?
- breastfeeding, oral sucrose and Skin-to-Skin contact
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2014to 31 Aug 2017
- 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 24 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational Age 38-40
- 2.5-4.0kg
- 24-48hours of age
- Receiving heel lance procedure
- Apgar>7 at birth
- NPASS<3 at time of heel lance
Who cannot join
- Prior heel lance procedure
- birth trauma
- forceps or vacuum delivery
- maternal drug abuse during delivery
About this study
Official title: Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance
The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.
Read the detailed description
This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.
A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.
The average pain score from two research nurses were used for statistical analysis.
- Conditions
- Pain, Breast Feeding
- Being tested
- breastfeeding, oral sucrose, Skin-to-Skin contact, Non-nutritive sucking
- Keywords
- neonates, Non-pharmacological
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeedingBehavioural
Newborns were breastfed during the procedure
oral sucroseDietary supplement
Newborns were given oral sucrose during the procedure
Skin-to-Skin contactBehavioural
Newborns were placed in direct contact with their mothers during the procedure
Non-nutritive suckingBehavioural
Also called Pacifier
newborns were given a pacifier to suck on during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Newborns received no pain interventions during the procedure |
| Breastfeeding | Experimental | Newborns were breastfed during the procedure Receives: Behavioral: breastfeeding |
| Oral Sucrose | Experimental | Newborns were given oral sucrose during the procedure Receives: Dietary Supplement: oral sucrose |
| Skin to skin contact | Experimental | Newborns were placed in direct contact with their mothers during the procedure Receives: Behavioral: Skin-to-Skin contact |
| Non-nutritive sucking | Experimental | Newborns were given a pacifier to suck on during the procedure Receives: Behavioral: Non-nutritive sucking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start7 Nov 2014
- Primary completion30 Sep 2015
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annette Nasr, Stanford University
- Investigators
- Jie Chang, BSN,MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421158
- Sponsor's protocol ID
- 31216
- Status last verified
- Dec 2017
- First submitted
- 29 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance
- ClinicalTrials.gov ID
- NCT03421158
- Acronym / sponsor ID
- 31216
- Conditions
- Pain, Breast Feeding
- Keywords
- neonates, Non-pharmacological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 5 Feb 2018 (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 purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.
Detailed description
This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.
A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.
The average pain score from two research nurses were used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Newborns received no pain interventions during the procedure |
| Breastfeeding | Experimental | Behavioral: breastfeedingNewborns were breastfed during the procedure |
| Oral Sucrose | Experimental | Dietary Supplement: oral sucroseNewborns were given oral sucrose during the procedure |
| Skin to skin contact | Experimental | Behavioral: Skin-to-Skin contactNewborns were placed in direct contact with their mothers during the procedure |
| Non-nutritive sucking | Experimental | Behavioral: Non-nutritive suckingNewborns were given a pacifier to suck on during the procedure |
Who may qualify
- Ages
- 24 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational Age 38-40
- 2.5-4.0kg
- 24-48hours of age
- Receiving heel lance procedure
- Apgar>7 at birth
Key exclusion criteria (4 listed)
- Prior heel lance procedure
- birth trauma
- forceps or vacuum delivery
- maternal drug abuse during delivery
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 |
|---|---|---|
| breastfeedingNewborns were breastfed during the procedure | Behavioural | Breastfeeding |
| oral sucroseNewborns were given oral sucrose during the procedure | Dietary supplement | Oral Sucrose |
| Skin-to-Skin contactNewborns were placed in direct contact with their mothers during the procedure | Behavioural | Skin to skin contact |
| Non-nutritive suckingAlso: Pacifiernewborns were given a pacifier to suck on during the procedure | Behavioural | Non-nutritive sucking |
Primary outcome
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
Time frame: 12 month
Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.
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 5 Feb 2018.
- Individual participant dataSharing planned: Yes
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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.
Jie Chang, BSN,MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding, oral sucrose and Skin-to-Skin contact in people with Pain and Breast Feeding, run by Stanford University.
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 6 inclusion and 4 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 5 Feb 2018. 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?
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?
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.