To assess the effectiveness of using a pictorial story in reducing the immunization pain in children and the anxiety of mothers between 3-6 years of age when compared to a group receiving a general story and one receiving no intervention.
- Conditions
- Pain during routine immunization
- Registration Number
- CTRI/2020/02/023112
- Lead Sponsor
- Fluid Research Grant of Christian Medical College Vellore
- Brief Summary
Children undergo unpredictable and procedure- related pain in hospitals that have negative emotional implications. These medical procedures cause anxiety, fear and distress not only in the children, but also the families, which further intensifies pain- interfering with the procedure.Maternal psychological symptoms and behaviors influence children’s pain. Even subtle display of parental anxiety can convey powerful messages regarding pain to children.
Medical procedures involving needles are the most feared experiences as reported by children. If this fear is not addressed, pain can lead to long term consequences such as pre procedural anxiety, health care avoidance behaviors and non adherence to vaccination schedules. Interventions to reduce vaccination pain include: Positioning involving sitting upright rather than lying supine, local anesthetics containing gels, creams and patches. Competency of clinicians administering vaccinations was found to mitigate vaccination pain.
Strong evidence supports educating parents on the effects of pain and its management before and on the day of immunization so that learning happens ahead of time. Education of children three years and older on the day of immunization by providing information of what will happen (procedural information), how it would feel (sensory information) and how to cope (strategies to mitigate pain and fear) have been found to mitigate pain response.
Social stories (Carol Gray) is an intervention based on providing procedural information by means of pictures. It is a positive, child-focused intervention designed to bridge the gap of a child’s social understanding and promote positive social behaviors.
The primary objective of this study is to develop a social story related to the immunization visit and to assess its effectiveness on pain perception. A story will prepare the child in advance for the immunization procedure in order to reduce pain perception in the age group of 3-6 years and maternal anxiety. Outcome with be compared with two control groups one receiving a placebo intervention involving a general story and one group receiving no intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
- Mothers having knowledge of Tamil or English.
- Child accompanied by mother.
- Hospitalization within the past year.
- Admission to the NICU in the neonatal period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain perception will be assessed using 3 scales, namely Sound, Eye and Motor (SEM) Scale; Observation Scale of Behavioral Distress and The Wong Baker FACES Pain Rating Scale. Anxiety will be assessed by General Anxiety- Visual Analog Scale (GA-VAS). Pain perception of the child will be assessed before and after the immunization using the Wong Bakers FACES Pain Rating Scale and during the immunization using the Observational Scale of Behavioral Distress. Anxiety in the mothers will be assessed after the intervention using the General anxiety- Visual Analog Scale (GA-VAS).
- Secondary Outcome Measures
Name Time Method Demographic characteristics of the mother will be assessed. The number and type of distraction techniques will also be noted.
Trial Locations
- Locations (1)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaAddlin Sarah APrincipal investigator9894269780addlinsarah2@gmail.com