The Effect of Methods Used During Blood Collection on Pain and Fear in Children

NCT06953531 | Not Yet Recruiting DMC

• 1 other identifier: University Mersin
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

The effect of three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure on pain, fear and procedure time will be investigated in pain-sensitive 6-12 age group children.

Conditions

Pain; Fear

Keywords

Blood collection process in children; Nursing

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Facial Expressions Rating Scale

  The Wong-Baker Facial Expressions Rating Scale will be used to assess the pain levels of children during the blood collection procedure and 5 minutes after the procedure. The scale includes six facial expressions representing increasing levels of pain, scored from 0 (no pain) to 5 or 10 (severe pain), depending on the version used.

  At the time of blood collection (0 minutes) and 5 minutes after the procedure

• Children's Fear Scale

  The Child Fear Scale, which is suitable for children aged 3 to 16, will be used to assess the level of fear and anxiety experienced by the child before and during the blood collection. The scale consists of five facial expressions scored from 0 (no fear and anxiety) to 4 (highest fear and anxiety), and can be administered by children, parents, or researchers.

  Immediately before and during the blood collection procedure.

Study Arms (4)

Local Skin Cooling Device Group

EXPERIMENTAL

Participants are given a cold application using a local skin cooling device just before the blood collection process.

Device: Cold Application (Local Skin Cooling Device)

Bubble Machine Group

EXPERIMENTAL

During the blood collection process, participants are entertained with the bubble machine.

Behavioral: Distraction Method (Bubble Machine)

Simulative Toy Group

EXPERIMENTAL

During the blood collection process, participants are distracted with a simulative toy.

Behavioral: Distraction Method (Simulative Toy)

Control Group

NO INTERVENTION

Participants are not subjected to any intervention during the blood collection process.

Interventions

Cold Application (Local Skin Cooling Device) DEVICE

Immediately before the blood collection procedure, cold application will be made to the area with a local skin cooling device.

Local Skin Cooling Device Group

Distraction Method (Bubble Machine) BEHAVIORAL

A bubble machine will be used to distract children during the blood collection process.

Bubble Machine Group

Distraction Method (Simulative Toy) BEHAVIORAL

A simulative toy will be used to distract children during the blood collection process.

Simulative Toy Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child must be between the ages of 6 and 12.
• The child's WB-YİDÖ score must be 0 before the blood collection procedure.
• The child must be willing to participate in the study and sign the Informed Consent Form/Written Consent Form.
• The child must be able to speak Turkish.
• The child must not have a mental disability and must be able to use their arms functionally.
• The child must not have used sedatives, analgesics, or narcotics within 6 hours prior to admission to the blood collection unit.
• The child's body temperature must be below 38 °C at the time of admission to the blood collection unit.
• The child must have undergone blood collection procedures before.
• The child must not be afraid of the simulation toy.

You may not qualify if:

• Failure to sign the Informed Consent Form/Written Consent Form.
• The child has a disease that causes chronic pain.
• The child has vision or hearing problems.
• Deterioration of skin integrity in the blood collection area or in the area where the local skin cooling device will be applied.
• Presence of nerve damage in the area where blood will be drawn.
• Having sensory motor deficit, diabetes, peripheral vascular disease (e.g., Raynaud's syndrome), neuropathy, or sickle cell anemia.
• The child has an allergy to the simulative toy.

Sponsors & Collaborators

• Hatice ŞEN: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hatice ŞEN Research Assıstant

CONTACT

+90 507 520 78 30; Haticesen3303@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 1, 2025
• Study Start: May 12, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share