Crochet Octopus in The Process of Heel Lance in Neonates

Procedural Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560374
• Other study ID #: 90139838-000-E.20252
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: April 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Pain

Intervention

Device:
• crochet octopus
Delivering crochet octopus to the hands of the neonates

Locations

Country	Name	City	State
Turkey	Giresun University Women and Children's Hospital	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonate Infant Pain Scale Score	Neonate Infant Pain Scale score calculated before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus. It is a 6-itemed scale developed to assess the pain occuring due to interventions implemented to term and premature infants. The scoring of the scale was realized by assessing five behavioral classification (mimics, crying, movements of arms and legs, wakefulness state) and one physological parameter (type of respiration). It needs too much time and is difficult to assess intubated infants. It is suitable for painful conditions of non-intubated infants . Total score calculated. The lowest score of the scale is 0; the highest one is 7 and 3+ score shows the presence of pain.	Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)
Secondary	Duration of Crying	Duration of crying counted before, durring and after heel lance procedure whom neonates delivered crochet octopus and not delivered crochet octopus.	Before the procedure (0th minute), during the procedure, after the procedure (2nd and 10th minutes)