- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143450
Efficacy of Manual Pressure in Infants
The Effect of Applying Manual Pressure Before Vaccination on Pain and Crying Time in Infants
Study Overview
Detailed Description
Vaccine injection is one of the most common causes of pain in healthy infants and children. Parents may avoid or delay vaccination to avoid the pain their child experiences repeatedly with vaccination. Avoiding or delaying vaccination by parents may lead to disruption of vaccination programs, and thus an increase in infectious diseases that can be prevented by vaccination. Therefore, the management of pain due to vaccine injection in children is very important. Many non-pharmacological methods are used to control vaccine-related pain in children. Manual pressure, which is one of these methods, is applied to the injection area with the thumb for 10 seconds before the injection. The pain control effect of manual pressure is explained by the gate control theory. According to this theory, the presence and severity of pain depend on the transmission of neurological stimuli. In summary, if the door is open, the warnings reach the level of consciousness and pain is felt, if it is closed, the warnings do not reach the consciousness and pain is not felt. Applications such as rubbing the pain area, pressing with a finger, massage provide closing the door to painful stimuli. The aim of the study is to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the DTaP-IPV-Hib vaccine (5-in-1) in 2-month-old infants.The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies which have been conducted using a similar research method. The sample size was found to be a total of 66 children including minimum of 33 children for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 70 children including 35 children in two groups. Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) Scale, and chronometer will use for data collection. Children's parents who applied to the Kumkapi Family Health Center will be given information about the study. Information about children and their parents included in the study will ask by the researcher through face-to-face interviews and these data will record in 'Information Form' five minutes before the procedure.
Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants in the experimental group. No non-pharmacological method will be used before vaccination to the infants in the control group. The latero-femoral region (vastus lateralis muscle) will be used as the injection site for vaccination. All infants in the intervention and control groups will be accompanied by their parents throughout the procedure. In addition, the chronometer will be started when the baby starts to cry, and the chronometer will be stopped when the crying stops. Total crying time will be recorded on the Information Form. Before, during, and after vaccination children's pain will evaluate with the FLACC Scale by the healthcare provider who performs the injection. Before and during venipuncture children's pain will evaluate with the FLACC Scale and their emotional status will evaluate with the Children's Emotional Manifestation Scale by the healthcare provider who performs the venipuncture procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Kumkapi Family Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being a healthy baby born at term
- Being 4 months old
- Having no chronic disease,
- Having no neurological disease.
- Not taking an analgesic drug within 24 hours before vaccination.
Exclusion Criteria:
- Being an unhealthy baby born at preterm or post-term,
- Being younger or older than 4 months old,
- Having a chronic disease,
- Having a neurological disease,
- Taking an analgesic drug within 24 hours before vaccination.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Experimental Group
Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher.
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In the experimental group manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher before the procedure.
Manual pressure reduces pain within the framework of the gate control theory.
According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated.
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NO_INTERVENTION: Control Group
No intervention will perform to reduce pain in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain
Time Frame: Before vaccine injection, when the vaccine starts to be injected and immediately after the injector was removed.
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Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale.
This scale was developed to evaluate the pain of children aged 2 months to 7 years.
The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain.
These five behaviors are rated with 0, 1, or 2 points.
The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain.
'0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.
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Before vaccine injection, when the vaccine starts to be injected and immediately after the injector was removed.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crying time
Time Frame: During vaccine injection and immediately after injection
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Crying time throughout vaccine injections will be calculated for each infant using a chronometer.
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During vaccine injection and immediately after injection
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-KAEK-53-21-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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