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Cognitive-Behavioral Care for Port Needle Insertion

NCT07170670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-09-18

No results posted yet for this study

Summary

This study aims to determine the effect of the Cognitive-Behavioral Intervention Package (CBIP) applied during port catheter needle insertion on pain, anxiety, and fear levels in children aged 6-18 years diagnosed with oncology.

Research Hypotheses

Between the Cognitive-Behavioral Intervention Package group (G1) and the control group (G2):

H1: There is a difference in the mean scores of the Wong-Baker FACES Pain Rating Scale (WB-FPRS) between the groups.

H2: There is a difference in the mean scores of the Children's Anxiety Scale between the groups.

H3: There is a difference in the mean scores of the Children's Fear Scale between the groups.

Prior to the intervention, researchers will administer the scales to the intervention group, followed by the implementation of the CBIP. After the port catheter needle insertion, the scales will be re-administered to evaluate the final levels of pain, anxiety, and fear.

Conditions

  • Cancer Associated Pain

Interventions

BEHAVIORAL

CBIP - Cognitive-Behavioral Intervention Package

Before the procedure, the researcher initiated social interaction with the child (cognitive distraction). Next, suggestions regarding the procedure were provided (guidance). A volunteer parent sat beside the child, providing support by holding the child's non-procedural hand. While the nurse performed the port catheter insertion, the researcher applied one of the behavioral distraction techniques chosen by the child during the pre-procedure phase, such as counting, singing, reading a poem, or answering questions (behavioral distraction). Upon completion of the procedure, the researcher provided positive reinforcement by praising the child ("Well done!" and "You were very brave!") and rewarding the child with a star and smiley face sticker on the collar (positive reinforcement).

Sponsors & Collaborators

  • Birgul Erdogan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2025-07-18
Completion
2025-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170670 on ClinicalTrials.gov