Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer Associated Pain

Keywords

Pediatric OncologyPort CatheterNon-Pharmacological InterventionCognitive-Behavioral InterventionPainAnxietyFear

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).

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 PackageBehavioral

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Are 6-18 years old,
Have a cancer diagnosis,

Sponsors & Collaborators

Birgul Erdogan
Otherlead

Study Sites (1)

Kocaeli University Faculty of Health Sciences

İzmit, Kocaeli, Turkey (Türkiye)

MeSH Terms

Conditions

Cancer PainPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Enrollment

54 participants (actual enrollment reported by the registry).

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

Actual (reported)

Cognitive-Behavioral Care for Port Needle Insertion

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

Cognitive-Behavioral Intervention Package Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

Cognitive-Behavioral Intervention Package Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations