Two Different Distraction Methods on Pain and Fear During Venipuncture in Children

NCT03645213 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E.40485
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common source of pain and fear, and generally experienced in childhood for the first time. This study was designed to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods. Method: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.

Conditions

Venipuncture Site Reaction; Procedural Complication; Nursing Caries

Keywords

School-age children; pain; fear; venipuncture; distraction

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measure

  Used for the pain intensity during the procedure was the Wong-Baker FACES Pain Rating Scale (WB-FBRS) which is represented by six animated faces arranged side by side from the worst pain to the mildest one (0-5). The range of painfulness from the smiling "no pain" (0 points) to the crying face of "the worst pain" (5 points) translated into the Turkish language

  Immediately after venipuncture

Secondary Outcomes (1)

• Fear Measure

  Immediately after venipuncture

Study Arms (3)

Virtual Reality (VR)

EXPERIMENTAL

Children were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. The display was a head-mounted VR box in the VR group.

Device: Virtual Reality Box

Non- Virtual Reality (VR)

EXPERIMENTAL

Children were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's. The display was a computer tablet in the non-VR group. The computer tablet was the 10 centimeters far from the child.

Device: Tablet Computer

Control

NO INTERVENTION

There was no additional intervention in the control group. Venipuncture procedures was the same other groups. The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's.

Interventions

Virtual Reality Box DEVICE

Virtual Reality box, a head-mounted display with stereo earphones transmits the cartoon image onto screens in front of the child's eyes. It was showed on Samsung Galaxy Note5 phone and Samsung Gear VR box /SM-R323N.

Virtual Reality (VR)

Tablet Computer DEVICE

The tablet computer is a device that children watch on a 7-inch screen.

Non- Virtual Reality (VR)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• being between 7-12 years old,
• a physician order was placed for blood sample,
• no current acute pain,
• no cognitive or severe physical disability,
• no communication difficult,

You may not qualify if:

• the blood sample cannot be taken in the first attempt
• no consent of the parents for the child to take part in the research

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (2)

• Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.

  PMID: 25817062 RESULT

• Karakaya A, Gozen D. The Effect of Distraction on Pain Level Felt by School-age Children During Venipuncture Procedure--Randomized Controlled Trial. Pain Manag Nurs. 2016 Feb;17(1):47-53. doi: 10.1016/j.pmn.2015.08.005. Epub 2015 Oct 12.

  PMID: 26459008 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Merdiye Şendir, Proffessor

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 24, 2018
• Study Start: September 18, 2017
• Primary Completion: April 2, 2018
• Study Completion: August 10, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)