The Effect of Interactive Games on Children Receiving Intravenous Injection

NCT04970823 | Unknown DMC

• 1 other identifier: 202012054RINC
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Fear; Emotions

Keywords

school-age children; injection; pain; Somatosensory interactive games

Outcome Measures

Primary Outcomes (4)

• Changes in children's pain from baseline to after intravenous injection

  Using Wong-Baker Faces Pain Rating Scale to measure pain. There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst." Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the pain levels experienced by the children receiving intravenous injections.

  O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)

• Changes in children's fear from baseline to after intravenous injection

  Using Children's Fear scale to measure the fear level. Score the chosen face from 0 (the left-most face) to 4 (the last face). This face \[point to the left-most face\] shows no anxiety at all, this faces shows a little bit more \[point to second face from left\], a bit more \[sweep finger along scale\], right up to extreme anxiety \[point to the last face on the right\]. Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the fear levels experienced by the children receiving intravenous injections.

  O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)

• Changes in children's emotion from baseline to after intravenous injection

  Using Children's Emotional Management Scales to measure the emotion level. The scale includes five observed emotional behavior categories, facial expression, vocalization, activity, interaction, and level of cooperation. Each category is scored from 1-5 points, the lowest total score is 5 points, and the highest score is 25 points. The higher the score, the more negative emotional behavior. Nurses, pre-school children by the assistance of caregivers, and school-age children were asked to evaluate the emotion levels experienced by the children receiving intravenous injections.

  O1 (before intervention); O2 (immediately after intravenous injection); O3 (1 day after intravenous injection)

• semi-structed interviews

  After intravenous injection, a semi-structured qualitative interview was conducted with selected and their parent to understand the differences in experience before and after intervention.

  immediately after intravenous injection

Study Arms (2)

The somatosensory interactive game

EXPERIMENTAL

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

Device: The somatosensory interactive game for preschool children

A VR (virtual reality) game

EXPERIMENTAL

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

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

Interventions

The somatosensory interactive game for preschool children DEVICE

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

The somatosensory interactive game

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

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

A VR (virtual reality) game

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• years old preschool children with developmental delay, epilepsy, heart disease, chemotherapy, visual and hearing impaired, obese, and have received more than 2 intravenous injections.
• 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.
• The child's parents cannot express and communicate effectively.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 640, Taiwan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Mei Chen, OTHERS

  NTUH Yunlin Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 21, 2021
• Study Start: March 8, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-01

Locations

TW (1)