PrematureVENOPUNCIPREMNCT04041635
Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.
A study testing Stimuli reduction in people with Premature and Pain, Procedural, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation. Read more about this study
- Who is it for?
- Ages 32 to 36 weeks
- Conditions the study is for
- Premature, Pain, Procedural
- What is being tested?
- Stimuli reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to Dec 2022
- 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 32 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature babies born between 32 and 36 weeks of gestation (both included).
- Haemodynamically stable.
- Require venipuncture and whose.
- Parents or legal guardians have signed informed consent forms.
Who cannot join
- Gestational age inferior to 32 weeks.
- Treated with intravenous or oral analgesics, sedatives or relaxants.
- Critical status or haemodynamically unstable.
- Requiring invasive mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Sergio Alonso-Fernández, RN, 0034934978437, salonso.germanstrias@gencat.cat
Maria Bonjorn-Juarez, RN, 0034934978926, mariabonjornjuarez@gmail.com
About this study
Official title: Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
Read the detailed description
Background: The evidence for the efficacy of reducing sensory stimulation and its effect on pain in minor procedures has not been studied in depth. There are no studies that evaluate the reduction of visual and auditory stimuli in a combined way.
Impact: It is easy to incorporate the reduction of visual and auditory stimuli into nursing practice.
Aims: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
Design: Open, randomized, non-blind parallel clinical trial. Methods: Study to take place at the neonatal intensive care unit at the Germans Trias i Pujol University Hospital in 2019-2021. 56 recently born babies between 32 and 36 weeks of gestation will participate. The dependent variable is level of pain determined using the Premature Infant Pain Profile (PIPP). The intervention will be assigned randomly using the random.org software. Data analysis will be carried out using the IBM SPSS v.25 software assuming a level of significance of 5%.
The results of this study could have a direct impact on clinical practice.
- Conditions
- Premature, Pain, Procedural
- Being tested
- Stimuli reduction, Usual care
- Keywords
- Pain, Premature, Visual stimuli, Auditory stimuli
- Medical subject headings
- Premature Birth, Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimuli reductionProcedure or surgery
Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure.
Usual careProcedure or surgery
Babies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced.
| Study group | Role | What they receive |
|---|---|---|
| Stimuli Reduction | Experimental | This group will receive reduced visual and auditory stimuli in addition to usual care during venipuncture. Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure. Receives: Procedure: Stimuli reduction |
| Usual Care | Active comparator | Babies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Premature Infant Pain Profile (PIPP) score
Calculation of pain response using a validated instrument (Premature Infant Pain Profile-PIPP). It varies from "0" (no pain to 21 (maximum pain response)
Measured: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Secondary outcomes (1)
Change in heart rate
Heart rate
Measured: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Jul 2019
- Primary completionJul 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
- Investigators
- Maria Bonjorn-Juarez, RN, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041635
- Sponsor's protocol ID
- PI-18-208
- Acronym
- VENOPUNCIPREM
- Status last verified
- Feb 2021
- First submitted
- 25 Jul 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonjorn Juarez M, Manrique Pons M, Grau Alcon L, Martinez-Momblan MA, Alonso-Fernandez S. Reduction of visual and auditory stimuli to reduce pain during venipuncture in premature infants. Study protocol for a randomized controlled trial. J Adv Nurs. 2020 Apr;76(4):1077-1081. doi: 10.1111/jan.14300. Epub 2020 Jan 10.
PubMed 31865625
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04041635
- Acronym / sponsor ID
- VENOPUNCIPREM / PI-18-208
- Conditions
- Premature, Pain, Procedural
- Keywords
- Pain, Premature, Visual stimuli, Auditory stimuli
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Aug 2019 (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 aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
Detailed description
Background: The evidence for the efficacy of reducing sensory stimulation and its effect on pain in minor procedures has not been studied in depth. There are no studies that evaluate the reduction of visual and auditory stimuli in a combined way.
Impact: It is easy to incorporate the reduction of visual and auditory stimuli into nursing practice.
Aims: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.
Design: Open, randomized, non-blind parallel clinical trial. Methods: Study to take place at the neonatal intensive care unit at the Germans Trias i Pujol University Hospital in 2019-2021. 56 recently born babies between 32 and 36 weeks of gestation will participate. The dependent variable is level of pain determined using the Premature Infant Pain Profile (PIPP). The intervention will be assigned randomly using the random.org software. Data analysis will be carried out using the IBM SPSS v.25 software assuming a level of significance of 5%.
The results of this study could have a direct impact on clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimuli Reduction | Experimental | Procedure: Stimuli reductionThis group will receive reduced visual and auditory stimuli in addition to usual care during venipuncture. Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure. |
| Usual Care | Active comparator | Procedure: Usual careBabies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature babies born between 32 and 36 weeks of gestation (both included).
- Haemodynamically stable.
- Require venipuncture and whose.
- Parents or legal guardians have signed informed consent forms.
Key exclusion criteria (4 listed)
- Gestational age inferior to 32 weeks.
- Treated with intravenous or oral analgesics, sedatives or relaxants.
- Critical status or haemodynamically unstable.
- Requiring invasive mechanical ventilation.
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 |
|---|---|---|
| Stimuli reductionPhototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure. | Procedure or surgery | Stimuli Reduction |
| Usual careBabies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced. | Procedure or surgery | Usual Care |
Primary outcome
Change in the Premature Infant Pain Profile (PIPP) score
Time frame: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Calculation of pain response using a validated instrument (Premature Infant Pain Profile-PIPP). It varies from "0" (no pain to 21 (maximum pain response)
1 secondary outcome
Change in heart rate
Time frame: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 31865625Bonjorn Juarez M, Manrique Pons M, Grau Alcon L, Martinez-Momblan MA, Alonso-Fernandez S. Reduction of visual and auditory stimuli to reduce pain during venipuncture in premature infants. Study protocol for a randomized controlled trial. J Adv Nurs. 2020 Apr;76(4):1077-1081. doi: 10.1111/jan.14300. Epub 2020 Jan 10.
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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.
Maria Bonjorn-Juarez, RN principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimuli reduction in people with Premature and Pain, Procedural, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. 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 Spain. 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 Sergio Alonso-Fernández, RN (0034934978437, salonso.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Premature Infant Pain Profile (PIPP) score (time frame: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041635, which also lists 1 linked publication.
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 3 Feb 2021.