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

NCT04558086 | Completed DMC

• 1 other identifier: 108163-F
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pian; Fear

Keywords

Therapeutic play,virtual reality, intravenous placement, school-age, pain, fear

Outcome Measures

Primary Outcomes (2)

• The degrees of pain experienced by the children.

  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 .

  The posttests 8 min after the tourniquets were worn.

• The degrees of fear experienced by the children.

  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.

  The posttests 8 min after the tourniquets were worn.

Study Arms (2)

Reduce pain and fear

EXPERIMENTAL

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.

Device: Virtual reality

control group

EXPERIMENTAL

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.

Device: Photo book

Interventions

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.

Reduce 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.

control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei County, 112, Taiwan

Location

MeSH Terms

Conditions

Yaws; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: June 5, 2020
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

TW (1)