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Cognitive-Behavioral Care for Port Needle Insertion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07170670
Enrollment
54
Registered
2025-09-12
Start date
2024-09-16
Completion date
2025-08-15
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Associated Pain

Keywords

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

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.

Interventions

BEHAVIORALCBIP - 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

Birgul Erdogan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sociodemographic Characteristics Form (SCF)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.
Wong-Baker FACES Pain Rating Scale (WB-FPRS)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.
Children's Fear Scale (CFS)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.
Children's Anxiety Scale-State (CAS-S)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026