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Comparison Effectiveness of Distractions on Pain and Fear of Children

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04977323
Enrollment
150
Registered
2021-07-26
Start date
2021-07-28
Completion date
2021-10-10
Last updated
2021-08-03

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

Conditions

Peripheral Intravenous Cannulation

Brief summary

Distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. Distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (Hockenberry & Wilson, 2018). The benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (Wente, 2013). There are two main types of distraction techniques: active and passive (Mutlu & Balcı, 2015; Wohlheiter & Dahlquist, 2013). Objectives: To evaluate the roles of the TICK-B, listening music, and watching cartoon, in relieving pain and fear of school-age children during PIVC. To compare the effect of TICK-B with the effects of the listening music, and watching cartoon, on reducing pain and fear during PIVC in children. To compare the effects of three distraction groups with the control group in relieving pain and fear during PIVC.

Detailed description

Peripheral intravenous cannulation (PIVC) is an invasive technique. In this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. It is the second most painful procedure performed in hospitals. Peripheral intravenous cannulation (PICV) is a common painful procedure for children, and nearly all ill children have experience with PIVC, and up to 80% of patients receive a peripheral venous cannula in a hospital. Therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children. In order to relieve pain and fear in children undergoing PICV. Psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. Application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. These approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. For this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.

Interventions

These interventions will use as distraction techniques.

Sponsors

University of Witten/Herdecke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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 PIVC.

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 Peripheral intravenous cannulation 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 anxiety5 minutes before procedure doneTo assess the fear level of the children related to Peripheral intravenous cannulation 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 pain.0 minute during peripheral cannulation insertion procedure(time during insertion of cannula).To assess the intensity of pain related to Peripheral intravenous cannulation 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 cannulation procedure.To assess the fear level of the children related to peripheral intravenous cannulation 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 cannualtion (1-2 minutes after procedure to mask observer)Visual Analog Scale (VAS) will be used to measure pain and fear of children by parent and observer.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026