The Effect of Interactive Games on Children Receiving Intravenous Injection

NCT ID: NCT04970823

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2021-12-31

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.

Conditions

Pain; Fear; Emotions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The somatosensory interactive game

The somatosensory interactive game, an independent nursing intervention, promotes pain relief on the experimental group.

Group Type: EXPERIMENTAL

The somatosensory interactive game for preschool children

Intervention Type: DEVICE

The somatosensory interactive game, an independent nursing intervention, promotes pain relief for preschool children.

A VR (virtual reality) game

A VR (virtual reality) game promotes pain relief on the experimental group.

Group Type: EXPERIMENTAL

A VR (virtual reality) game for school-age children

Intervention Type: DEVICE

A VR (virtual reality) game environment promotes pain relief for school-age children.

Interventions

The somatosensory interactive game for preschool children

The somatosensory interactive game, an independent nursing intervention, promotes pain relief for preschool children.

Intervention Type: DEVICE

A VR (virtual reality) game for school-age children

A VR (virtual reality) game environment promotes pain relief for school-age children.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui-Mei Chen, OTHERS

Role: PRINCIPAL_INVESTIGATOR

NTUH Yunlin Branch

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202012054RINC

Identifier Type: -

Identifier Source: org_study_id