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

Premature Clinical Trial

— VENOPUNCIPREM  

Official title:

Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04041635
• Other study ID #: PI-18-208
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: February 2021
• Source: Germans Trias i Pujol Hospital
• Contact: Sergio Alonso-Fernández, RN
• Phone: 0034934978437
• Email: salonso.germanstrias[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Procedural
• Premature
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundació Institut Germans Trias i Pujol

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in heart rate	Heart rate	From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture