Clinical trial NCT04970823: The Effect of Interactive Games on Children Receiving Intravenous Injection
Official title: The Effect of Somatosensory Interactive Games on the Pain, Fear and Negative Emotions of Children Receiving Intravenous Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Fear
Emotions
Keywords: school-age children
injection
pain
Somatosensory interactive games
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 202
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. The purpose of this study is to examine the effectiveness of somatosensory interactive games on intravenous pain relief for preschool children, and to establish a VR (virtual reality) game environment for school-age children. Using a randomized experimental study, the data came from the pediatric ward. The results will show whether there is a statistically significant difference between the experimental group and the control group.

Detailed description: Pediatric intravenous injection is one of the most painful events that children may be exposed to during hospitalization or illness, and it is also the most routinely performed invasive procedure. Non-pharmaceutical techniques can be used to relieve pain associated with intravenous injections. Distraction is a non-pharmacological technique that can take child's attention away from pain. The somatosensory interactive game is an independent nursing intervention that promotes pain relief. The purpose of this study is to examine the effectiveness of somatosensory interactive games on intravenous pain relief for preschool children, and to establish a VR (virtual reality) game environment for school-age children. Using a randomized experimental study, the data came from the pediatric ward. At least qualified 132 preschool children are in this study and their caregivers signed a consent form to participate in the study. Children are divided into experimental group and control group, and each group has at least 66 children. In addition to 60 school-age children, 30 played VR games for about 3 minutes during intravenous injection, and 30 received regular intravenous injection. The preschool experimental group and the school-age experimental group each took the parents of 5 children (10 in total) to conduct semi-structured qualitative interviews to understand the differences in experience before and after the intervention. This study is expected to accept a total of 202 children and parents. Data collection tools include WBFPS (Wong-Baker Faces Scale) to measure children's pain and CFS (Children's Fear scale) to measure children's fear. CEMS continue assessment negative emotion two days. The results will show whether there is a statistically significant difference between the experimental group and the control group. Qualitative study used semi-structed interviews were conducted with selected and their parent.

Eligibility criteria: Inclusion criteria:

1. 2-7 years old, normal consciousness, preschool children who need intravenous injection.
2. 7-12 years old, normal consciousness, school-age children who need intravenous injection.
3. Parents of children need to be conscious and able to talk in Chinese.

Exclusion criteria:

1. 2-7 years old preschool children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
2. 7-12-year-old school-age children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
3. The child's parents cannot express and communicate effectively.

Primary outcomes:
measure: Changes in children's pain from baseline to after intravenous injection
timeFrame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
measure: Changes in children's fear from baseline to after intravenous injection
timeFrame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
measure: Changes in children's emotion from baseline to after intravenous injection
timeFrame: O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)
measure: semi-structed interviews
timeFrame: immediately after intravenous injection
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH Yunlin Branch
name: Hui-Mei Chen, OTHERS
role: PRINCIPAL_INVESTIGATOR
References: