Comparison of the Effectiveness of Distraction

July 27, 2021 updated by: Sherzad Khudeida Suleman, University of Witten/Herdecke

Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Active Distractions on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial

Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients.

No randomized studies have compared the effectiveness of balloon inflation, cough trick, and TICK-B on reducing pain in children between 6 and 12 years old during the drawing of venous blood samples. The research hypothesis was that children who draw and color a picture, inflate a balloon, or perform the cough trick while having their blood taken would experience less pain and anxiety than children who did not undergo a pain-reducing intervention.

Objectives:

To evaluate the roles of the TICK-B, balloon inflation, and cough trick in relieving pain and fear of school-age children during venipuncture.

To compare the effect of TICK-B with the effects of the cough trick, balloon inflation, on reducing pain and anxiety during venipuncture in children.

To compare the effects of three distraction groups with the control group in relieving pain and anxiety during venipuncture.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients. Approximately 83% of young children aged 2.5-6 years, 51% of youngsters aged 7-12 years, and 28% of adolescents (aged more than 12 years) who underwent venipuncture stated high levels of distress during the painful procedure. However, < 10% of venipuncture performing are given pain management.

To relieve pain, fear, and anxiety in children undergoing venipuncture or venous cannulation, both pharmacological and non-pharmacological approaches are used to help control pediatric patients' discomfort. Pain management includes pharmacologic and non-pharmacologic approaches. The most commonly used pharmacological approach to decrease medical procedure-related pain is the application of topical anesthetic creams. Non-pharmacological methods include distraction actions like blowing bubbles, reading, or playing a game.

Balloon inflation causes a reduction in venous return with increased intrathoracic pressure. It has been speculated that this increase in pressure induces baroreceptor activation with contraction of the pulmonary vessels and that the activation of cardiopulmonary and sinoaortic baroreceptor reflex arcs has an antinociceptive effect, resulting in pain relief.

Coughing increases intrathoracic pressure and stimulation to the autonomic nervous system, causing an increase in heart rate and blood pressure, a higher level of pressure in the subarachnoid space, and baroreceptor activation. The increase in pressure in the subarachnoid space activates the segmental pain inhibiting pathways; thus, the increase in blood pressure and baroreceptor activation appears to be efficacious in reducing the perception of pain.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • School-aged 6-12 years old.
  • Children who require venipuncture.

Exclusion Criteria:

  1. Respiratory chronic diseases,
  2. Physical impairment,
  3. Disability contributing to difficult communication,
  4. Children of unsatisfied parents,
  5. Children with neurodevelopment delay,
  6. Cognitive impairment, hearing impairment or a visual impairment,
  7. Taking an analgesic within 6 hours, or for those with a syncope history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TICK-B group as intervention group
TICK-B group: The children will receive a picture as they want. They will be asked to trace and color the pictures that need coloring. After the procedure, the child will take his or her picture which he colored during the procedure.
Other: TICK-B group
These interventions will distract the child during venipuncture
Other Names:
  • Coughing trick group
  • Balloon inflation group
  • Control group or no intervention
Experimental: Coughing trick
Coughing trick: Children in this group will be taught how to cough during the procedure. coughs with start moderate force and then coughs again which coincides with a needle procedure, such as venipuncture for example.
Other: TICK-B group
These interventions will distract the child during venipuncture
Other Names:
  • Coughing trick group
  • Balloon inflation group
  • Control group or no intervention
Experimental: Balloon inflation group as intervention group
Balloon inflation group: In this group, the children will receive a balloon colored as their favorite, and they will be asked to inflate the balloon before starting the venipuncture procedure.
Other: TICK-B group
These interventions will distract the child during venipuncture
Other Names:
  • Coughing trick group
  • Balloon inflation group
  • Control group or no intervention
No Intervention: Standard care provided group as control group
Standard care provided group as the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
Time Frame: 5 minutes before procedure done.

To assess the intensity of pain related to the venipuncture procedure in children.

Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
5 minutes before procedure done.
Fear
Time Frame: 5 minutes before venipuncture procedure done

To assess the fear level of the children related to the venipuncture procedure.

Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
5 minutes before venipuncture procedure done

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain
Time Frame: 0 minute during venipuncture procedure (time during insertion of cannula).

To assess the intensity of pain related to venipuncture procedure in children:

Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
0 minute during venipuncture procedure (time during insertion of cannula).
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.
Time Frame: 1-2 minute after venipuncture procedure done.

To assess the intensity of pain related to the venipuncture procedure in children.

Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.
1-2 minute after venipuncture procedure done.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time Frame: 0 minute during venipuncture procedure.

To assess the fear level of the children related to venipuncture procedure:

-Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
0 minute during venipuncture procedure.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety
Time Frame: 1-2 minute after venipuncture procedure done.

To assess the fear level of the children related to the venipuncture procedure:

-Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.
1-2 minute after venipuncture procedure done.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS), to measure the pain and Fear of children by the parents and observer.
Time Frame: Immediately after venipuncture (1-2 min.)
Visual Analog Scale (VAS) will be used to measure pain and fear of children during venipuncture by parent and observer
Immediately after venipuncture (1-2 min.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Witten/Herdecke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SRS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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