Cognitive-Behavioral Care for Port Needle Insertion

Birgul Erdogan

Status: Completed

Conditions: Cancer Associated Pain

Treatments: Behavioral: CBIP - Cognitive-Behavioral Intervention Package

Study type: Interventional

Funder types: Other

Identifiers

NCT07170670

2024-25\04

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Cognitive-Behavioral Intervention Package Group

Experimental group

Description:

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.

Treatment:

Behavioral: CBIP - Cognitive-Behavioral Intervention Package

Control Group

No Intervention group

Description:

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