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Effectiveness of hot tub bath in pain of hospitalized children

Effectiveness of hot immersion bath in pain management of hospitalized children: Randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5cjpz86
Enrollment
Unknown
Registered
2022-10-05
Start date
2022-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Criança Hospitalizada

Interventions

This is a two-arm, open-label, randomized controlled clinical trial.The sample will be composed of two groups: 1) Control Group (CG), which will be composed of 42 children with respiratory problems un
T1-Checking the pain 15 minutes after the medication has been administered
T2- Pain verification after 30 minutes of medication having been performed, and T3- Pain verification after 60 minutes of medication being performed.

Sponsors

Escola de Enfermagem da Universidade de São Paulo
Lead Sponsor
Hospital Universitário da Universidade de São Paulo
Collaborator

Eligibility

Age
28 Days to 2 Years

Inclusion criteria

Inclusion criteria: Children who meet the following criteria will be included in the study: Children between 28 days and 2 years old, hospitalized in the Pediatric Inpatient Unit/Ward for respiratory problems; Children with pain, evaluated by validated scales: Neonatal Infant Pain Scale (NIPS), whether it is: severe, moderate or mild pain; or Face, Legs, Activity, Cry, Consolability (FLACC), be it: severe, moderate or mild pain; Have the permission of their parents or guardians to participate in this study. In addition to these criteria, the inclusion of the same child within 12 hours of the last inclusion in the study will also be allowed if the child is not under the influence of pain management medications and the last medication for this purpose was taken within 6 hours, considering the time of action of the most used drugs.

Exclusion criteria

Exclusion criteria: Exclusion criteria will be: Children over 2 years of age; Children using positive pressure ventilation (CPAP); Children awaiting transfer to the Intensive Care Unit (ICU) due to worsening respiratory distress, since the immersion bath can cause crying and irritability and the condition worsens; Children who have taken any medication for pain management within 6 hours of pain detection using the validated scales; Children with a previous diagnosis of chronic pain. It is worth mentioning that there are medications that are used both for pain management and for other conditions, for example dipyrone, which in addition to being an analgesic also has antipyretic properties, and can be used in the management of fever. Thus, the researcher at the time of collection will pay attention to the medications that were previously administered to the child and whether they have analgesic properties, in order to avoid inclusion bias. If they also act in pain management, the medication must have been administered within a 6-hour interval prior to the moment of pain detection.

Design outcomes

Primary

MeasureTime frame
It is expected to find that the hot immersion bath in hospitalized children provides, together with the medication, a reduction in the intensity of pain. Verified through inferential analysis with the presentation of pain scores by the FLACC scale (Face, Legs, Activity, Cry, Consolability), which we will observe each parameter of the scale.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactDanton Souza

Hospital Universitário da Universidade de São Paulo

danton_souza@usp.br+55-11984592342

Outcome results

None listed

Source: REBEC (via WHO ICTRP)