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

Not Applicable

• Conditions: Pain, Procedural; Premature

• Registration Number: NCT04041635
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the Premature Infant Pain Profile (PIPP) score	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)

Secondary Outcome Measures

Name	Time	Method
Change in heart rate	From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture	Heart rate

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain