Efficacy of Manual Pressure in Infants
Condition: Pain Management
Study type: Interventional

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.
    

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.
    

Intervention name(s): Manual Pressure
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: injection; manual pressure; pain; pain management; vaccination