Clinical trial NCT04041635: Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.
Official title: Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature
Pain, Procedural
Keywords: Pain
Premature
Visual stimuli
Auditory stimuli
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fundació Institut Germans Trias i Pujol
First posted: 2019-08-01
Enrollment: 52
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in the Premature Infant Pain Profile (PIPP) score
timeFrame: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Secondary outcomes:
measure: Change in heart rate
timeFrame: From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol University Hospital
name: Maria Bonjorn-Juarez, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.