Comparison of the Effectiveness of Distraction

University of Witten/Herdecke

Status: Unknown

Conditions: Venipuncture

Treatments: Other: TICK-B group

Study type: Interventional

Funder types: Other

Identifiers

NCT04983303

SRS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 4 patient groups

TICK-B group as intervention group

Experimental group

Description:

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.

Treatment:

Other: TICK-B group

Coughing trick

Experimental group

Description:

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.

Treatment:

Other: TICK-B group

Balloon inflation group as intervention group

Experimental group

Description:

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.

Treatment:

Other: TICK-B group

Standard care provided group as control group

No Intervention group

Description:

Standard care provided group as the control group