Cognitive-Behavioral Care for Port Needle Insertion

NCT07170670 | Completed

• 1 other identifier: 2024-25\04
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Oncology; Port Catheter; Non-Pharmacological Intervention; Cognitive-Behavioral Intervention; Pain; Anxiety; Fear

Outcome Measures

Primary Outcomes (4)

• Sociodemographic Characteristics Form (SCF)

  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)

  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)

  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)

  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).

Study Arms (2)

Cognitive-Behavioral Intervention Package Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

In the study, children in the control group will receive the routine clinical procedure prior to the intervention, followed by port catheter needle insertion.

Interventions

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).

Cognitive-Behavioral Intervention Package Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birgul Erdogan: lead

Study Sites (1)

Kocaeli University Faculty of Health Sciences

İzmit, Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cancer Pain; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant, PhD

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 12, 2025
• Study Start: September 16, 2024
• Primary Completion: July 18, 2025
• Study Completion: August 15, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)