The Effect of Two Different Structured Balls on Pain and Fear Levels During Venous Blood Collection in Children

NCT04631094 | Completed

• 1 other identifier: Pediatric Nursing
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

Pain causes many physiological and psychological changes in the body, increases the level of anxiety in children, and prolongs examination and other procedures. Pain should be evaluated individually for each child, taking into account individual differences in pain level and response to pain. From the moment of birth, human beings have been exposed to many invasive interventions throughout their lives and experience pain and anxiety as a result. Experiences with childhood pain shape children's future pain responses. This study, which was planned to stimulate the touch receptors of two different balls used during venous blood collection, is a randomized controlled study in order to determine the effect on the pain and fear levels of children aged 6-12 years. A total of 310 children were included in the study. The experimental groups included in the study were asked to hold the balls with their hands according to their groups, no attempt was made to the control group. The research data were obtained with the Wong-Baker Faces Pain Rating Scale and Child Fear Scale, which will be used in the evaluation. In addition, oxygen saturation and heart rate were evaluated immediately before and after removal of the tourniquet.

Conditions

Nurse's Role

Keywords

child, fear, nursing, pain, venipuncture

Outcome Measures

Primary Outcomes (2)

• Pain level as assessed with Wong-Baker Faces Pain Rating Scale

  This scale to be used to assess pain in our study was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. The scale is widely used to measure pain intensity in children over the age of three. Pain is scored according to numerical values assigned to faces that show an expression spectrum; smiling face represents no pain (0 points), crying face represents severe pain (10 points). The scale is a valid and reliable tool for measuring procedural pain severity. Permission for the scale was obtained from the official website of the Wong-Baker Faces Foundation. The Turkish translation of the scale was sent by Nick Baker, official site official of the Wong-Baker Faces Foundation.

  during the procedure

• Fear as assessed using the Child Fear Scale

  It is used to determine the child's fear and anxiety level. Fear and anxiety are assessed on a five-point scale. The single-item scale consists of five facial expressions regardless of gender. The first facial expression of the scale is neutral and has a value of zero. The last facial expression is worth four points expressing extreme fear. In this study, Child Fear Scale will be used to evaluate the fear levels of children in the experimental and control groups before and after the bloodletting procedure. The scale was introduced into the Turkish language by Gerçeker et al. (2018). Test-retest reliability of the Child Fear Scale was found to be quite high, and its content validity index was determined as 0.89. Since the scale is in the form of scoring, item-total correlation and Cronbach alpha coefficient could not be calculated.

  during the procedure

Study Arms (5)

Group 1

EXPERIMENTAL

The group holding the serrated ball in the hand on the extremity from which venous blood will be taken

Other: The group holding the serrated ball in the hand on the extremity from which venous blood will be taken

Group 2

EXPERIMENTAL

The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken.

Other: The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken.

Group 3

EXPERIMENTAL

The group holding a smooth ball in the hand on the extremity from which venous blood will be taken

Other: The group holding a smooth ball in the hand on the extremity from which venous blood will be taken

Group 4

EXPERIMENTAL

The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.

Other: The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.

Group 5

NO INTERVENTION

The group that will undergo standard hospital blood collection procedure.

Interventions

The group holding the serrated ball in the hand on the extremity from which venous blood will be taken OTHER

Children in the experimental groups will squeeze the serrated ball during the blood draw.

Also known as: serrated ball

Group 1

The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. OTHER

Children in the experimental groups will squeeze the serrated ball during the blood draw.

Also known as: serrated ball

Group 2

The group holding a smooth ball in the hand on the extremity from which venous blood will be taken OTHER

Children in the experimental groups will squeeze the smooth ball during the blood draw.

Also known as: smooth ball

Group 3

The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken. OTHER

Children in the experimental groups will squeeze the smooth ball during the blood draw.

Also known as: smooth ball

Group 4

Eligibility Criteria

• Age: 6 Years - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- The volunteerism of the child and the parent to participate in the research,
• The child is between the ages of 5-12,
• The child and the parent speaks Turkish, Taking blood from the cephalic vein,
• Turnstile not being tied for more than 30 seconds,
• Not taking any analgesic (systemic or topical), antipyretic, anti-inflammatory drugs in the last 12 hours,
• Body temperature between 36.5-37.2 ⁰C,
• Not having a disease that can cause chronic pain,
• No acute pain or anxiety during the procedure,
• Absence of skin integrity problems,
• No obstacle to grip the balls in hand,
• Children who do not have regular invasive interventions (no chronic diseases that require blood control such as cancer, diabetes),
• Blood collection was performed at the first attempt,
• The child does not have any auditory, mental or neurological disability that will affect his participation in the research.

You may not qualify if:

• \- The child and the parents are not willing to participate in the research,
• The child is not between the ages of 5-12,
• The child and the parent do not speak Turkish, Inability to take blood from the cephalic vein,
• Turnstile remaining tied for more than 30 seconds,
• Taking any medication with analgesic (systemic or topical), antipyretic or anti-inflammatory effects in the last 12 hours,
• Body temperature lower than 36.5 C-37.2 ⁰C,
• Having a disease that can cause chronic pain,
• Children who undergo regular invasive interventions (having chronic diseases that require blood control such as cancer, diabetes), Failure to take blood at the first attempt,
• Any acute pain or anxiety during the procedure,
• Problems with skin integrity,
• It has an obstacle to grip the balls,
• Having an auditory, mental or neurological disability that will affect the child's participation in the research,
• Children in the control group want or involuntarily hold their parent's hand or something else during the procedure.

Sponsors & Collaborators

• Zeynep Yurdakul: lead

Study Sites (1)

Ankara University

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Figen Işık ESENAY

  assistant professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The results were planned by the statistician as the evaluator and the experts who will score the video recording, blindly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: November 17, 2020
• Study Start: January 4, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 30, 2021
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: always
• Access Criteria: Considering that repeated attempts may increase pain and anxiety in children, blood sampling cannot be performed in the first attempt, * Children in the control group wanting or involuntarily holding their parents' hand or anything during the procedure, * Failure to enter the vein within 20 seconds of grasping the ball, * Failure to take blood from the cephalic vein, * The children in the experimental group let go of the ball in their hands during the procedure.

Locations

TU (1)