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Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. (VENOPUNCIPREM)

Primary Purpose

Premature, Pain, Procedural

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stimuli reduction
Usual care
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature focused on measuring Pain, Premature, Visual stimuli, Auditory stimuli

Eligibility Criteria

32 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Gestational age inferior to 32 weeks.
  • Treated with intravenous or oral analgesics, sedatives or relaxants.
  • Critical status or haemodynamically unstable.
  • Requiring invasive mechanical ventilation.

Sites / Locations

  • Hospital Universitari Germans Trias i PujolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimuli Reduction

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in heart rate
Heart rate

Full Information

First Posted
July 25, 2019
Last Updated
February 2, 2021
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol
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1. Study Identification

Unique Protocol Identification Number
NCT04041635
Brief Title
Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.
Acronym
VENOPUNCIPREM
Official Title
Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Pain, Procedural
Keywords
Pain, Premature, Visual stimuli, Auditory stimuli

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimuli Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stimuli reduction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Premature Infant Pain Profile (PIPP) score
Description
Calculation of pain response using a validated instrument (Premature Infant Pain Profile-PIPP). It varies from "0" (no pain to 21 (maximum pain response)
Time Frame
From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Secondary Outcome Measure Information:
Title
Change in heart rate
Description
Heart rate
Time Frame
From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Gestational age inferior to 32 weeks. Treated with intravenous or oral analgesics, sedatives or relaxants. Critical status or haemodynamically unstable. Requiring invasive mechanical ventilation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Alonso-Fernández, RN
Phone
0034934978437
Email
salonso.germanstrias@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Bonjorn-Juarez, RN
Phone
0034678116280
Email
mariabonjornjuarez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Bonjorn-Juarez, RN
Organizational Affiliation
Germans Trias i Pujol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Alonso-Fernández, RN
Phone
0034934978437
Email
salonso.germanstrias@gencat.cat
First Name & Middle Initial & Last Name & Degree
Maria Bonjorn-Juarez, RN
Phone
0034934978926
Email
mariabonjornjuarez@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Bonjorn-Juarez, RN
First Name & Middle Initial & Last Name & Degree
Laia Grau-Alcon, RN
First Name & Middle Initial & Last Name & Degree
Meritxell Manrique-Pons, RN
First Name & Middle Initial & Last Name & Degree
Maria Antonia Martinez-Momblan, RN,MSN,PhD
First Name & Middle Initial & Last Name & Degree
Sergio Alonso-Fernández, RN,MSN,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31865625
Citation
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.
Results Reference
derived

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Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.

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