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Completed

NCT Number: NCT04558086

The Effects of Using an Interactive Game With Virtual Reality for Children During Intravenous Placement

To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.

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Key information

Conditions

Pian Bacterial Infections Bacterial Infections and Mycoses Fear Gram-Negative Bacterial Infections Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Spirochaetales Infections Treponemal Infections Yaws

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei County, 112, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children ages 6-12.
  • Children who where clearly conscious.
  • Children who agreed and were required to receive intravenous injections after physicians' diagnoses.
  • Children and their primary caregivers who could communicate in Mandarin or Taiwanese
  • Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

Exclusion criteria

  • Children with developmental delay, epilepsy, or heart diseases
  • Children undergoing chemotherapy; children who were visually or hearing impaired
  • Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters.
  • Children who had sustained head trauma in the past month
  • Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
  • Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
  • Children who received two or more intravenous injections and had their blood drawn only one time

Treatment and study plan

Virtual reality

Device

To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.

Photo book

Device

To develop the intervention strategies of hospitalized school-age children with IV placement, using Photo book to further examine the effectiveness of reducing IV pain and fear.

Primary outcomes

  1. The degrees of pain experienced by the children.

    Time frame: The posttests 8 min after the tourniquets were worn.

    Measurement of pin using the Wong-Baker Faces Pain Rating Scale (WBFPS). The scale contains six cartoon faces shwing pain ratings of 0~10, which are, from left to right, no pain(0), a little pain (2), mild pain (4), average pain (6), severe pain (8), and excruciating pain (10).The children, primary caregivers, and nurses were asked to select the faces that best described the pain levels experienced by the children receiving intravenous injections; the pain levels were subsequently converted into numerical values .

  2. The degrees of fear experienced by the children.

    Time frame: The posttests 8 min after the tourniquets were worn.

    Measurement of fear using the Choldren Fear Scale(CFS).The scale consists of five cartoon faces showing fear ratings of 0-4, which were no fear (0), a little fear (1), some fear (2), very fear(3) and extreme fear (4). The children, primary caregivers, and nurses were asked to select the faces that best described the fear levels of the children receiving intravenous injections. The pain levels were subsequently converted into numerical values.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

The Effects of Using an Interactive Game With Virtual Reality to Reduce the Pain and Fear for Children During an Intravenous Placement

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 22, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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