Skip to content

Comparison of the Effectiveness of Distraction

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04983303
Enrollment
150
Registered
2021-07-30
Start date
2021-08-01
Completion date
2021-10-01
Last updated
2021-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venipuncture

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.

Interventions

These interventions will distract the child during venipuncture

Sponsors

University of Witten/Herdecke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain5 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.
Fear5 minutes before venipuncture procedure doneTo 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

MeasureTime frameDescription
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain0 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.
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 anxiety0 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.

Other

MeasureTime frameDescription
Visual Analog Scale (VAS), to measure the pain and Fear of children by the parents and observer.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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026