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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature, Pain, Procedural

Intervention / Treatment
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* Procedure: Stimuli reduction
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimuli Reduction<br>This group will receive reduced visual and auditory stimuli in addition to usual care during venipuncture. 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: Stimuli reduction<br>* 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.<br>|
| Active Comparator: Usual Care<br>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. | Procedure: Usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Heart rate | From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Premature, Visual stimuli, Auditory stimuli