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

NCT04041635 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-02-03

No results posted yet for this study

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.

Conditions

  • Premature
  • Pain, Procedural

Interventions

PROCEDURE

Stimuli reduction

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

Usual care

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.

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Maria Bonjorn-Juarez, RN · Germans Trias i Pujol University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-07-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04041635 on ClinicalTrials.gov