PainNCT00547807
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial
A study testing Non-nutritive sucking and Swaddling in people with Pain, run by Sociedade Hospital Samaritano at 1 site in Brazil.
Trial summary
Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. Read more about this study
- Who is it for?
- Ages 2 to 5 days
- Conditions the study is for
- Pain
- What is being tested?
- Non-nutritive sucking and Swaddling
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Feb 2009
- 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 2 to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term healthy neonates
Who cannot join
- NICU admission
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Sociedade Hospital Samaritano
São Paulo, São Paulo, 01232-010
Eliseth R Leão, PhD, 55 11 38215891, eliseth.leao@samaritano.org.br
About this study
Official title: Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial
Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. The hypothesis of the study is that association between non-nutritive sucking and swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking alone.
- Conditions
- Pain
- Being tested
- Non-nutritive sucking, Swaddling
- Keywords
- Pain, neonate, nursing care
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-nutritive suckingOther
Also called complementary therapy
Non-nutritive sucking is applied by using a gloved finger
SwaddlingOther
Swaddling is an age-old practice of wrapping infants snugly in swaddling cloths, blankets or similar cloth so that movement of the limbs is tightly restricted
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Measured: pre painfull procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2009
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.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedade Hospital Samaritano
- Sponsor type
- University, hospital or other
- Investigators
- Mariana Bueno, MSN, Principal investigator, Sociedade Hospital SamaritanoEdna A Bussotti, RN, Principal investigator, Sociedade Hospital SamaritanoAndréia Silva, RN, Principal investigator, Sociedade Hospital Samaritano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547807
- Sponsor's protocol ID
- SHS 52/06
- Status last verified
- Feb 2009
- First submitted
- 22 Oct 2007
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00547807
- Acronym / sponsor ID
- SHS 52/06
- Conditions
- Pain
- Keywords
- Pain, neonate, nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sociedade Hospital SamaritanoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- First posted
- 23 Oct 2007 (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.
Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. The hypothesis of the study is that association between non-nutritive sucking and swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Term healthy neonates
Key exclusion criteria (1 listed)
- NICU admission
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 |
|---|---|---|
| Non-nutritive suckingAlso: complementary therapyNon-nutritive sucking is applied by using a gloved finger | Other | – |
| SwaddlingSwaddling is an age-old practice of wrapping infants snugly in swaddling cloths, blankets or similar cloth so that movement of the limbs is tightly restricted | Other | – |
Primary outcome
pain score
Time frame: pre painfull procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
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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.
Mariana Bueno, MSN principal investigator
Sociedade Hospital Samaritano
Edna A Bussotti, RN principal investigator
Sociedade Hospital Samaritano
Andréia Silva, RN principal investigator
Sociedade Hospital Samaritano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-nutritive sucking and Swaddling in people with Pain, run by Sociedade Hospital Samaritano at 1 site in Brazil.
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 1 inclusion and 1 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 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Eliseth R Leão, PhD (55 11 38215891, eliseth.leao@samaritano.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: pre painfull procedure). 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 26 Feb 2009.