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NCT Number: NCT07170670

Cognitive-Behavioral Care for Port Needle Insertion

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.

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Key information

Conditions

Cancer Associated Pain Anxiety Disorders Cancer Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Faculty of Health Sciences

İzmit, Kocaeli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBIP - Cognitive-Behavioral Intervention Package

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Birgul Erdogan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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