NCT04041635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

July 25, 2019

Last Update Submit

February 2, 2021

Conditions

PrematurePain, Procedural

Keywords

PainPrematureVisual stimuliAuditory stimuli

Outcome Measures

Primary Outcomes (1)

  • 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)

    From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture

Secondary Outcomes (1)

  • Change in heart rate

    From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture

Study Arms (2)

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.

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.

Procedure: Usual care

Interventions

Stimuli reductionPROCEDURE

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.

Stimuli Reduction
Usual carePROCEDURE

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.

Usual Care

Eligibility Criteria

Age32 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31865625DERIVED

MeSH Terms

Conditions

Premature BirthPain, ProceduralPain

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Bonjorn-Juarez, RN

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Alonso-Fernández, RN

CONTACT

0034934978437salonso.germanstrias@gencat.cat

Maria Bonjorn-Juarez, RN

CONTACT

0034678116280mariabonjornjuarez@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

August 1, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

December 1, 2022

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

ES(1)