Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.

Pain Clinical Trial

Official title:

Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436185
• Other study ID #: interventional
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2020
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.

Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

Inclusion Criteria:

• Born at full term

• No infection, redness, deteriorated skin integrity, or nerve damage in the area of application

• Had not undergone any clinical injection.

Exclusion Criteria:

• Infants who have applied analgesics before the vaccination

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Comparisons of procedural pain
This randomized experimental study with placebo and control groups

Locations

Country	Name	City	State
Turkey	Inonu Üniversity	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Infant Pain Scale (NIPS)	NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83	10 minutes