Crochet Octopus in The Process of Heel Lance in Neonates

Marmara University

Status: Completed

Conditions: Procedural Pain

Treatments: Device: crochet octopus

Study type: Interventional

Funder types: Other

Identifiers

NCT04560374

90139838-000-E.20252

Details and patient eligibility

About

The main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates.

The hypothesis of the study was "Crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates".

Full description

The study was conducted as randomized controlled. It included term neonates born between May 2020 and August 2020 at a training and research hospital. The study was completed with 100 neonates in total as 50 for experiment and 50 for control groups. During the process of heel lance, experiment group neonates were delivered crochet octopus 10 minutes before the process and let them touch the octopus 10 minutes more after the process. Control group neonates experienced the process without any intervention. As for the data collection, "Newborn Identification Form", "Neonatal-Infant Pain Scale (NIPS)" and "Observation Form" were utilized. The whole process was video-recorded.

Enrollment: 100 patients

Sex: All

Ages: 5 to 15 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• being a healthy term neonates,
• being 5-15 days,
• taking of blood sample for Guthrie test routinely.

Exclusion criteria

• admitted to the neonatal intensive care units
• his/her being taken any analgesics prior to the intervention,
• having any congenital anomalies

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Crochet octopus was delivered to the hands of the neonates in the experimental group 10 minutes before heel lance process and they were contacted with the crochet octopus up to 10 minutes after the procedure.

Treatment:

Device: crochet octopus

Control Group

No Intervention group

Description:

Control group neonates were performed all the process without delivering them any crochet octopus.