Pain, Procedural, Premature
Conditions
Keywords
Pain, Premature, Visual stimuli, Auditory stimuli
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.
Interventions
PROCEDUREStimuli 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.
PROCEDUREUsual 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.
Sponsors
Fundació Institut Germans Trias i Pujol
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 36 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate | From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture | Heart rate |
Countries
Spain
Contacts
Primary ContactSergio Alonso-Fernández, RN
Backup ContactMaria Bonjorn-Juarez, RN
Outcome results
None listed