Cognitive-Behavioral Care for Port Needle Insertion

NCT ID: NCT07170670

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2025-08-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CBIP - Cognitive-Behavioral Intervention Package

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Birgul Erdogan

OTHER

Sponsor Role: lead

Responsible Party

Birgul Erdogan

Principal Investigator, Research Assistant, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kocaeli University Faculty of Health Sciences

İzmit, Kocaeli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-25\04

Identifier Type: -

Identifier Source: org_study_id