Comparison of the Effectiveness of Distraction

Not Applicable

• Conditions: Venipuncture
• Interventions: Other: TICK-B group

• Registration Number: NCT04983303
• Lead Sponsor: University of Witten/Herdecke

Brief Summary

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.

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 Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Study First Posted: 2021-07-30
• Last Update Posted: 2021-07-30
• Study Start: 2021-08-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TICK-B group as intervention group	TICK-B 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.
Coughing trick	TICK-B group	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.
Balloon inflation group as intervention group	TICK-B 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.

Primary Outcome Measures

Name	Time	Method
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain	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.
Fear	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.

Secondary Outcome Measures

Name	Time	Method
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.	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.
Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety	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.
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain	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.