Clinical trial NCT04560374: Crochet Octopus in The Process of Heel Lance in Neonates
Official title: The Effect of Using Crochet Octopus in Reducing The Pain Developed During The Process of Heel Lance İn Neonates: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Keywords: neonate
pain
heel lance
developmental care
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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".

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonate Infant Pain Scale Score
timeFrame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
Secondary outcomes:
measure: Duration of Crying
timeFrame: Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University Women and Children's Hospital
Study officials:
affiliation: Marmara University
name: Cagri Covener Ozcelik, PhD
role: STUDY_CHAIR
affiliation: Marmara University
name: Özge Eren, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Nagihan Sabaz, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Giresun University
name: Muhammet Bulut, MD
role: PRINCIPAL_INVESTIGATOR
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