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Effect of Buzzy® cooling and vibration on pain perception and success of peripheral venipuncture in hospitalized children clinical trial

Effect of vibration and cryotherapy with Buzzy® on pain perception and success of peripheral intravenous catheterization in hospitalized children parallel and open clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3cf3zj3
Enrollment
Unknown
Registered
2024-06-13
Start date
2024-04-01
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

Pain

Interventions

Participants in this subproject will be randomly allocated into two groups, called the intervention group, formed by children who will receive the Buzzy® 60 seconds before Peripheral Intravenous Cathe
E02.258

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Laboratório de Estudos e Pesquisas em Inovação e Segurança no Cuidado em Saúde - Universidade Estadual de Feira de Santana
Collaborator

Eligibility

Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Age between 4 to 12 years incomplete; elective indication for peripheral intravenous catheterization with catheter over needle; peripheral intravenous catheterization performed regardless of shift; stable clinical or surgical conditions; first peripheral intravenous catheterization performed at the hospital

Exclusion criteria

Exclusion criteria: Being hospitalized in wards that require the use of some specific contact or respiratory precautionary measure; be in the preoperative period that requires peripheral intravenous catheterization immediately before being transferred to the operating room; have a medical request to collect a blood sample for laboratory tests during the peripheral intravenous catheterization; having a skin lesion near the catheter insertion site, which will prevent Buzzy from positioning; Having previous nerve damage in areas close to the region to be catheterized or any report of limited sensitivity in the extremity listed for insertion of the intravenous catheter; Have peripheral neuropathy; being diagnosed with a disease associated with hypersensitivity to cold such as Raynaud's Syndrome or sickle cell disease; having used topical, enteral or parenteral analgesics between four to eight hours before catheterization; presence of cognitive impairment or inability to verbally report pain

Design outcomes

Primary

MeasureTime frame
Evaluate the presence of children's perception of pain during Peripheral Intravenous Catheterization, verified through the use of a vibration and cryotherapy device, based on the verification of an effectiveness variance of 5% between the groups that used the intervention

Secondary

MeasureTime frame
Evaluate the level of pain (mild, moderate and severe) of children during the performance of Peripheral Intravenous Catheterization, verified through the use of a vibration and cryotherapy device, based on the verification of a variance of effectiveness of pain reduction of 5 % among groups that used the intervention

Countries

Brazil

Contacts

Public ContactUliana Catapano

Universidade Federal de São Paulo

ulicatapano@hotmail.com+55(75)991176976

Outcome results

None listed

Source: REBEC (via WHO ICTRP)