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

NCT ID: NCT06953531

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2025-12-31

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.

Detailed Description

Children are usually admitted to the hospital for diagnosis, treatment or follow-up at an early stage of their lives and are subjected to various invasive procedures during this process. Blood collection is one of the interventions that are repeated many times by children during diagnosis and treatment, causing a feeling of pain and fear. Although bloodletting may seem like a minor procedure, it is considered a source of great fear by children and therefore turns into an unpleasant experience by both children and their families.

Pain management is both an ethical obligation and a child's right, which should be done by focusing on the needs and preferences of children and their parents, requires accurate and effective planning. Nonpharmacological treatment methods used in pain management in children are classified into three groups: physical, supportive and cognitive-behavioral methods. The use of Coolsense, a local skin cooling device, is a method that can be used in this sense in terms of its rapid effect. Coolsense; it is a hand-held device that has an effect in as little as five seconds, does not contain chemicals, has a temperature-controlled head, can be stored in the freezer of refrigerators and used repeatedly. Among the advantages of the device are that it is easy to use, it is applied to a small area and it is easy to Decipher whether it is at the right temperature from the light burning on it. The most preferred method among cognitive-behavioral methods is the method of diverting attention Decently. The method of diverting attention is divided into two as active and passive methods. One of the methods of attracting active attention is the use of toys. One of these toys is a bubble machine. The bubble machine is a toy with the ability to produce a large number of bubbles at the same time with its multi-hole design. With this toy, the child focuses on the bubbles that come out through the bubble machine, and not on the painful process, so his attention is diverted from the blood collection process. Another one of the toys is a simulative toy. Simulative toy; it is a toy that can show realistic and vivid features, contains sensors sensitive to touch and movement, breathes, can open and close its eyes, can move its head and body, and at the same time make sounds as if it were real. With these features, it can be effective in reducing pain and fear by ensuring that children's attention is diverted from the painful procedure. It is thought that three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure in pain-sensitive 6-12 age group children may have a positive effect on pain, fear and procedure time.

Conditions

Pain; Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Local Skin Cooling Device Group

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

Group Type: EXPERIMENTAL

Cold Application (Local Skin Cooling Device)

Intervention Type: DEVICE

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

Bubble Machine Group

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

Group Type: EXPERIMENTAL

Distraction Method (Bubble Machine)

Intervention Type: BEHAVIORAL

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

Simulative Toy Group

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

Group Type: EXPERIMENTAL

Distraction Method (Simulative Toy)

Intervention Type: BEHAVIORAL

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cold Application (Local Skin Cooling Device)

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

Intervention Type: DEVICE

Distraction Method (Bubble Machine)

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

Intervention Type: BEHAVIORAL

Distraction Method (Simulative Toy)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hatice ŞEN

OTHER

Sponsor Role: lead

Responsible Party

Hatice ŞEN

Research Assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hatice ŞEN Research Assıstant

Role: CONTACT

Haticesen3303@gmail.com

+90 507 520 78 30

Other Identifiers

University Mersin

Identifier Type: -

Identifier Source: org_study_id