Clinical Trials Directory

Trials / Unknown

UnknownNCT04970823

The Effect of Interactive Games on Children Receiving Intravenous Injection

The Effect of Somatosensory Interactive Games on the Pain, Fear and Negative Emotions of Children Receiving Intravenous Injection

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
202 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
2 Years – 12 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEThe somatosensory interactive game for preschool childrenThe somatosensory interactive game, an independent nursing intervention, promotes pain relief for preschool children.
DEVICEA VR (virtual reality) game for school-age childrenA VR (virtual reality) game environment promotes pain relief for school-age children.

Timeline

Start date
2021-03-08
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2021-07-21
Last updated
2021-07-21

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04970823. Inclusion in this directory is not an endorsement.