Vaccine-Related Pain in Infants

NCT02808637 | Completed DMC

• 1 other identifier: CANKIRI KARATEKIN UNIVERSITY
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib. The study population included all the infants presenting for DTaP/IPV/Hib to two family health centers between April and August in 2015. The study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. The sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. There were 32 infants in each group. Gender was adjusted in all groups. Stratified and block randomizations were used.

Conditions

Pain

Keywords

Pain management; vaccination; manual pressure; needle aspiration

Outcome Measures

Primary Outcomes (3)

• Pain severity

  Video recordings obtained were evaluated by two pain specialists separately by using NIPS. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections. Pain severity, were expressed as the average score NIPS. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.

  6 MONTHS

• Crying time

  Video recordings taken were watched by the same researcher and crying time (sec) before, during and after vaccine injections was calculated for each infant. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.

  6 MONTHS

• Physiological Changes (heart rate and oxygen saturation)

  the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation (%) and heart rate (min) before, during and after the injections in each child. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.

  6 MONTHS

Study Arms (4)

Manual Pressure

EXPERIMENTAL

Other: Manual Pressure

Rapid Injection without Aspiration

EXPERIMENTAL

Other: Rapid Injection without Aspiration

Manual Pressure + Rapid Injection without Aspiration

EXPERIMENTAL

Other: Manual Pressure + Rapid Injection without Aspiration

Control

EXPERIMENTAL

Other: Control

Interventions

Manual Pressure OTHER

First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered in accordance with the conventional injection technique.

Manual Pressure

Rapid Injection without Aspiration OTHER

First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using rapid injection without aspiration technique.

Rapid Injection without Aspiration

Manual Pressure + Rapid Injection without Aspiration OTHER

First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered by using the rapid injection without aspiration technique.

Manual Pressure + Rapid Injection without Aspiration

Control OTHER

First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using the conventional injection technique.

Control

Eligibility Criteria

• Age: 4 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants who were aged 4-6 months, had the percentiles of 3P - 97P, were born at term and were not given any analgesics before immunization and whose mothers gave written informed consent were included.

You may not qualify if:

• Infants whose percentiles were below 3P and above 97P and who had acute infectious diseases, underwent topical anesthesia and/or took analgesics were excluded from the study.

Sponsors & Collaborators

• Çankırı Karatekin University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN, ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 22, 2016
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06