Effects of Squeezing Ball and Using Adhesive Remover on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula

NCT06371612 | Completed

• 1 other identifier: MersinU*GUGUCU_004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric nurses have a key role in reducing pain related to interventions during the hospitalisation process. In this context, according to the type of invasive intervention, the nurse determines the appropriate non-pharmacological methods for the effective management of pain, taking into account the child\'s individuality, developmental stage and clinical presentation. For children during the hospitalisation process, the removal of a peripheral venous line is a painful and stressful experience, as is the insertion of a peripheral venous line. Children experience acute pain during the removal of hypoallergenic adhesives used for fixation of the peripheral venous line. The practice guideline recommends the use of alcohol-free silicone-based aerosol sprays for the removal of medical adhesive/ fixation materials (NICU Brain Sensitive Care Committee, 2015). In this study, it was aimed to examine the effect of ball squeezing (active distraction) as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal.

Conditions

Procedural Pain; Fear of Pain

Keywords

pain; fear; children

Outcome Measures

Primary Outcomes (2)

• Pain assesed by Wong-Baker FACES

  The Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

  during the removal of the peripheral intravenous cannula

• Fear by Children's Fear Scale

  The Child Fear Scale was used.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to 4 (extreme fear). Higher scores mean a worse outcome.

  during the removal of the peripheral intravenous cannula

Secondary Outcomes (2)

• Pain assesed by Wong-Baker FACES

  at 2nd minutes after the removal of the peripheral intravenous cannula

• Fear by Children's Fear Scale

  at 2nd minutes after the removal of the peripheral intravenous cannula

Study Arms (3)

Standard Care

ACTIVE COMPARATOR

First, the physical comfort of the children will be ensured in the invasive procedure room. In standard care practice, the parental presence is supported during all invasive procedures performed on children. Two minutes before the removal of the peripheral intravenous cannula, cotton balls soaked in antiseptic solution and squeezed will be gently applied to the fixation area.

Other: Standard Care

Adhesive Remover Spray

ACTIVE COMPARATOR

First, the physical comfort of the children will be ensured in the invasive procedure room. Two minutes prior to the removal of the peripheral intravenous cannula, an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site. The children will be supported by their parents.

Other: Adhesive Remover Spray

Ball Squeezing + Adhesive Remover Spray

EXPERIMENTAL

: First, the physical comfort of the children will be ensured in the invasive procedure room. Two minutes prior to the removal of the peripheral intravenous cannula, an alcohol-free silicone-based aresol spray for medical use will be gently applied to the fixation site. At the same time, children will start squeezing the stress ball. The ball squeezing intervention will be terminated when the removal of the peripheral intravenous cannula is completed. The children will be supported by their parents.

Behavioral: Ball Squeezing + Adhesive Remover Spray

Interventions

Ball Squeezing + Adhesive Remover Spray BEHAVIORAL

Parental Presence + an alcohol-free silicone-based aresol spray for medical use + squeezing the stress ball

Ball Squeezing + Adhesive Remover Spray

Standard Care OTHER

Parental Presence

Standard Care

Adhesive Remover Spray OTHER

Parental Presence + an alcohol-free silicone-based aresol spray for medical use

Adhesive Remover Spray

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child aged 6-9 years
• Child with need or plan for the removal of the peripheral intravenous cannula (antecubital fossa of arm, superficial dorsal venous of hand)

You may not qualify if:

• Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
• Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

Related Publications (1)

• Guzel Polat O, Ugucu G, Akdeniz Uysal D, Polat N, Tuzun O, Sonmez Duzkaya D, Celebioglu A. Effects of using an adhesive remover spray and squeezing a stress ball on pain and fear of pain during peripheral intravenous cannula removal in children aged 6-9 years: A randomized controlled trial. J Pediatr Nurs. 2025 Sep-Oct;84:23-29. doi: 10.1016/j.pedn.2025.05.009. Epub 2025 May 16.

  PMID: 40381428 RESULT

MeSH Terms

Conditions

Pain, Procedural; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Guzide UGUCU, PhD, MScN

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A, B and C. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2024
• Primary Completion: July 7, 2024
• Study Completion: September 1, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)