Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature
- Sponsor
- Germans Trias i Pujol Hospital
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in the Premature Infant Pain Profile (PIPP) score
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change in the Premature Infant Pain Profile (PIPP) score
Time Frame: 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 Outcomes
- Change in heart rate(From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture)