Infant
Conditions
Interventions
The study will consist on a sample of 30 infants – 10 in each group – with their respective guardians, as recommended by Whitehead et al (2016), in their study where they estimate the sample needed fo
E02.880.130
Sponsors
Faculdade de Ciências da Saúde do Trairí (FACISA) - Universidade Federal do Rio Grande do Norte (UFRN)
Faculdade de Ciências da Saúde do Trairí (FACISA) - Universidade Federal do Rio Grande do Norte (UFRN)
Eligibility
Age
3 Months to 6 Months
Inclusion criteria
Inclusion criteria: Infants from 3 to 6 months old, with one of their guardians; of both sexes; born full term; without health conditions diagnoses or reflux complaints; without respiratory symptoms; which parents or guardians, greater 18 years old, authorize their participation
Exclusion criteria
Exclusion criteria: Participants (infant and guardian) who do not attend three scheduled evaluation attempts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It will be assessed the infant's sleep/wake status, presence or absence of pain using the Children and Infant's Postoperative Pain Scale (CHIPPS) and perception of comfort and acceptance of the equipment by infants and guardians through a questionnaire designed for this purpose, where there are items related to handling the equipment, observation of the infant's comfort after 5, 10 and 15 minutes during use, evaluation of the benefit of the equipment and degree of general satisfaction with the device, in addition to the perception of comfort by their guardians who will be using the equipment with the infant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Respiratory rate (RR), heart rate (HR), peripheral oxygen saturation (SpO2) and pulmonary auscultation (PA) will be observed, with the RR obtained by counting the respiratory incursions for 1 minute, the HR and SpO2 will be obtained using a pulse oximeter and the pulmonary auscultation using a stethoscope positioned on the infant's chest. These measurements will be performed before, during (0, 5, 10 and 15min) and after (5, 10, 15 and 20min) the use of the equipment. | — |
Countries
Brazil
Contacts
Public ContactKarolinne Monteiro
Faculdade de Ciências da Saúde do Trairí (FACISA) - Universidade Federal do Rio Grande do Norte (UFRN)
Outcome results
None listed