Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05143450 |
| Other study ID # |
2015-KAEK-53-21-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2021 |
| Est. completion date |
June 2, 2022 |
Study information
| Verified date |
November 2021 |
| Source |
Biruni University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Manual pressure is an effective, easy-to-apply, no preparation, and cost-effective method of
reducing pain associated with the injection. This study will be carried out 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 Diphtheria-Tetanus-Acellular Pertussis Vaccine
(DTaP), Inactivated Polio Vaccine (IPV), and Haemophilus Influenzae Type b Vaccine (Hib)
(5-in-1) in 2-month-old infants. The study will be conducted with the randomized controlled
experimental method. 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. Pain scores of infants in the intervention and control groups will be evaluated
before, during, and after vaccination. In addition, the total crying times of the babies will
be calculated and recorded with a stopwatch.
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.
