Blood SamplingCasaNCT02803723
"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants
A study testing Holding-cuddling and Sucrose in people with Blood Sampling, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants. Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Blood Sampling
- What is being tested?
- Holding-cuddling and Sucrose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalization at CHU de la Réunion - site sud in Neonatal Intensive Care Unit or Neonatology Unit. (Neonate reanimation, pediatric reanimation or Neonatology services)
- Informed consent from holder(s) of the parental authority
Who cannot join
- Intubated ou sedated patients
- Treated with a combined analgesic during venipuncture
- Having indications against sucrose
- For which behavorial items from DAN scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)
About this study
"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.
Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.
Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.
- Conditions
- Blood Sampling
- Being tested
- Holding-cuddling, Sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holding-cuddlingProcedure or surgery
The "Holding-cuddling" is started 5 minutes before veinipuncture.
SucroseProcedure or surgery
The sucrose adminstration is started 2 minutes before veinipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Holding-cuddling + Sucrose | Experimental | The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling. Receives: Procedure: Holding-cuddling; Procedure: Sucrose |
| Sucrose alone | Active comparator | The sucrose administration is started 2 minutes before blood sampling. Receives: Procedure: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Pain
Measure of pain by DAN scale at the time of the veinopuncture
Measured: At 0 and 30 seconds after the veinopuncture
Secondary outcomes (3)
Cardiac Frequency
Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after
Measured: At 0 and 30 seconds after veinopuncture
Oxygen saturation
Measure of the oxygen saturation at the time of the veinopuncture and 30 seconds after
Measured: At 0 and 30 seconds after veinopuncture
Pain at 1 min
Measure of pain by DAN scale 1 minute after veinopuncture
Measured: 1 min after veinopincture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SamplingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco BONSANTE, MD, Principal investigator, CHU de La RéunionSilvia IACOBELLI, MD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803723
- Sponsor's protocol ID
- 2015/CHU/08
- Acronym
- Casa
- Status last verified
- May 2016
- First submitted
- 30 May 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants
- ClinicalTrials.gov ID
- NCT02803723
- Acronym / sponsor ID
- Casa / 2015/CHU/08
- Conditions
- Blood Sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 17 Jun 2016 (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.
"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.
Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.
Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holding-cuddling + Sucrose | Experimental | Procedure: Holding-cuddling, Procedure: SucroseThe Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling. |
| Sucrose alone | Active comparator | Procedure: SucroseThe sucrose administration is started 2 minutes before blood sampling. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Hospitalization at CHU de la Réunion - site sud in Neonatal Intensive Care Unit or Neonatology Unit. (Neonate reanimation, pediatric reanimation or Neonatology services)
- Informed consent from holder(s) of the parental authority
Key exclusion criteria (4 listed)
- Intubated ou sedated patients
- Treated with a combined analgesic during venipuncture
- Having indications against sucrose
- For which behavorial items from DAN scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)
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 |
|---|---|---|
| Holding-cuddlingThe "Holding-cuddling" is started 5 minutes before veinipuncture. | Procedure or surgery | Holding-cuddling + Sucrose |
| SucroseThe sucrose adminstration is started 2 minutes before veinipuncture. | Procedure or surgery | Holding-cuddling + Sucrose, Sucrose alone |
Primary outcome
Evolution of Pain
Time frame: At 0 and 30 seconds after the veinopuncture
Measure of pain by DAN scale at the time of the veinopuncture
3 secondary outcomes
Cardiac Frequency
Time frame: At 0 and 30 seconds after veinopuncture
Oxygen saturation
Time frame: At 0 and 30 seconds after veinopuncture
Pain at 1 min
Time frame: 1 min after veinopincture
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 11 Feb 2020.
- 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.
Francesco BONSANTE, MD principal investigator
CHU de La Réunion
Silvia IACOBELLI, MD principal investigator
CHU de La Réunion
Questions about this trial
What is this clinical trial studying?
A study testing Holding-cuddling and Sucrose in people with Blood Sampling, run by Centre Hospitalier Universitaire de la Réunion.
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 2 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 11 Feb 2020. 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?
Evolution of Pain (time frame: At 0 and 30 seconds after the veinopuncture). 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 11 Feb 2020.