Cognitive-Behavioral Care for Port Needle Insertion

September 12, 2025 updated by: Birgul Erdogan

Cognitive-Behavioral Intervention Package for Port Catheter Needle Insertion: Effects on Pain, Anxiety, and Fear in Children With Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Kocaeli
      • İzmit, Kocaeli, Turkey (Türkiye)
        • Kocaeli University Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Are 6-18 years old,
  • Have a cancer diagnosis,
  • Have undergone at least one prior port catheter needle insertion,
  • Are willing to participate along with parental consent.

Exclusion Criteria:

  • Have any visual, auditory, verbal, or cognitive impairment,
  • Are in the terminal stage of the disease,
  • Have a history of sedative, analgesic, or narcotic use within 24 hours prior to enrollment,
  • Have a fever or history of infection at the time of enrollment,
  • Have a pre-procedure WB-FPRS score of 2 or higher unrelated to the procedure,
  • Do not complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive-Behavioral Intervention Package Group
Before the procedure, children's pain, anxiety, and fear were assessed by the child, parent, and researcher. In the CBIP group, preparation, briefing, and implementation stages were conducted. The researcher met with the child and parent for preparation and briefing. A volunteer parent was trained to support the child during the procedure (e.g., sitting next to the child, holding hands, talking). Port catheter needle insertion was performed according to unit routine by the same nurse with 5 years' experience, using a single attempt. After the procedure, children rated pain (WB-FPRS), fear (CFS), and anxiety (CAS); the observing parent and researcher also completed CFS and CAS.
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).
No Intervention: Control Group
In the study, children in the control group will receive the routine clinical procedure prior to the intervention, followed by port catheter needle insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic Characteristics Form (SCF)
Time Frame: At baseline, prior to intervention (Day 1)
The form was developed by the researchers based on the literature. It consists of 11 questions addressing the sociodemographic characteristics of parents and children, as well as the status of port catheter needle insertion.
At baseline, prior to intervention (Day 1)
Wong-Baker FACES Pain Rating Scale (WB-FPRS)
Time Frame: Before and after port catheter needle insertion (Day 1).
Pain will be assessed using the Wong-Baker FACES Pain Rating Scale (WB-FPRS) and completed by the child before and after the port catheter needle insertion. Scores range from 0 to 5, where 0 indicates no pain and 5 indicates unbearable pain.
Before and after port catheter needle insertion (Day 1).
Children's Fear Scale (CFS)
Time Frame: Before and after port catheter needle insertion (Day 1).
Fear will be assessed using the Children's Fear Scale (CFS) by the child, parent, and researcher before and after the port catheter needle insertion. Scores range from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear.
Before and after port catheter needle insertion (Day 1).
Children's Anxiety Scale-State (CAS-S)
Time Frame: Before and after port catheter needle insertion (Day 1).
Anxiety will be assessed using the Children's Anxiety Scale-State (CAS-S) as reported by the child, parent, and researcher before and after the port catheter needle insertion. Scores range from 0 to 5, where 0 indicates no anxiety and 5 indicates extreme anxiety.
Before and after port catheter needle insertion (Day 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birgul Erdogan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Actual)

July 18, 2025

Study Completion (Actual)

August 15, 2025

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Estimated)

September 12, 2025

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-25\04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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