The Effect of Watching Video and Blowing Paper Pinwheels in Children

NCT06489353 | Recruiting

• 1 other identifier: CF24157B
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate if watching videos and blowing paper pinwheels can reduce pain and fear in children undergoing venipuncture. The participant population includes hospitalized children aged 3-6 years old undergoing venipuncture for the first time. The main questions it aims to answer are:

• Watch their preferred cartoons on an iPad during the venipuncture process.
• Blow paper pinwheels to distract themselves during the venipuncture process.
• Be accompanied by a family member who will help in holding the child and providing comfort.

Conditions

Pain; Fear

Outcome Measures

Primary Outcomes (3)

• Wong-Baker Faces Pain Scale (WBFPS) for Children's Self-Reported Pain

  The Wong-Baker Faces Pain Scale (WBFPS) is used to measure children's self-reported pain levels. It consists of a series of facial expressions ranging from a smiling face (0) indicating "no pain" to a crying face (10) indicating "worst pain." The child points to the face that best describes their pain.

  Assessed immediately before and after the venipuncture.

• FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Assessment Scale

  The FLACC scale is used to measure pain in children by evaluating five criteria: Face (facial expressions), Legs (movement and positioning), Activity (overall movement and muscle tone), Cry (verbal expressions of pain), and Consolability (the child's ability to be comforted). Each criterion is scored from 0 to 2, with a total score ranging from 0 to 10. Higher scores indicate greater pain severity.

  Assessed immediately before and after the venipuncture procedure.

• Children's Fear Scale (CFS)

  The Children's Fear Scale (CFS) is used to evaluate the level of fear experienced by children during venipuncture. The scale consists of five facial expressions ranging from a neutral face (0) indicating "no fear" to a very frightened face (4) indicating "high fear." The nurse observes the child's facial expressions and assigns a score based on the child's appearance and behavior during the procedure.

  Assessed immediately before and after the venipuncture procedure.

Secondary Outcomes (2)

• Parental State Anxiety Scale (PSAS)

  Assessed immediately after the child's venipuncture procedure.

• Satisfaction of parents

  Assessed immediately after the child's venipuncture procedure.

Study Arms (3)

Video-watching group

EXPERIMENTAL

Participants will watch age-appropriate and engaging videos during the venipuncture procedure to distract them from pain and fear.

Behavioral: Video-watching

Blowing Pinwheels

EXPERIMENTAL

Participants will blow pinwheels during the venipuncture procedure, using breathing control and distraction to reduce pain and fear.

Behavioral: Blowing Pinwheels

routine care group

NO INTERVENTION

Participants will receive standard routine care during the venipuncture procedure without additional interventions, serving as the control group.

Interventions

Video-watching BEHAVIORAL

Participants will watch age-appropriate and engaging videos.

Video-watching group

Blowing Pinwheels BEHAVIORAL

Participants will blow pinwheels during the venipuncture procedure

Blowing Pinwheels

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 3-6 years.
• undergoing intravenous infusion or blood draw during the hospital stay.

You may not qualify if:

• chronic diseases.
• developmental delays or epilepsy.
• difficulty speaking.
• hearing or visual impairments.
• use sedatives within the past 6 hours.
• history of fainting during intravenous infusion or blood draw.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans' General Hospital

Taichung, 407219, Taiwan

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Hui-Ming Hou, MD

  Taichung Veterans' General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HuiMing Hou, MD

CONTACT

0933252727; hmjj6x@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 1. Randomization and Allocation: Participants are randomly assigned to one of three groups using a computer-generated table. Group assignments are sealed in opaque envelopes and revealed by a research coordinator not involved in assessments. 2. Blinding Care Providers: The nurse is unaware of the group assignment. The coordinator informs the parent and child of the intervention just before the procedure. 3. Blinding outcomes assessor: Outcome assessors and data analysts are kept blind to group assignments and only receive anonymized data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Nurse, Department of Nursing

Model Details: Participants will: * Be randomly assigned to one of three groups in parallel for the duration of the study: * Watch their preferred cartoons on an iPad during the venipuncture process. * Blow paper pinwheels to distract themselves during the venipuncture process. * Receive standard care without any additional distractions.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: July 5, 2024
• Study Start: July 18, 2024
• Primary Completion: May 16, 2025
• Study Completion: December 30, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)