Cancer Associated PainNCT07170670
Cognitive-Behavioral Care for Port Needle Insertion
A study testing CBIP - Cognitive-Behavioral Intervention Package in people with Cancer Associated Pain, run by Birgul Erdogan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cancer Associated Pain
- What is being tested?
- CBIP - Cognitive-Behavioral Intervention Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Health Sciences
İzmit, Kocaeli
About this study
Official title: Cognitive-Behavioral Intervention Package for Port Catheter Needle Insertion: Effects on Pain, Anxiety, and Fear in Children With Cancer
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
Read more
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
- Being tested
- CBIP - Cognitive-Behavioral Intervention Package
- Keywords
- Pediatric Oncology, Port Catheter, Non-Pharmacological Intervention, Cognitive-Behavioral Intervention, Pain, Anxiety, Fear
- Medical subject headings
- Cancer Pain, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBIP - Cognitive-Behavioral Intervention PackageBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after port catheter needle insertion (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start16 Sep 2024
- Primary completion18 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Associated PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birgul Erdogan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Birgul Erdogan, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170670
- Sponsor's protocol ID
- 2024-25\04
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Intervention Package for Port Catheter Needle Insertion: Effects on Pain, Anxiety, and Fear in Children With Cancer
- ClinicalTrials.gov ID
- NCT07170670
- Acronym / sponsor ID
- 2024-25\04
- Conditions
- Cancer Associated Pain
- Keywords
- Pediatric Oncology, Port Catheter, Non-Pharmacological Intervention, Cognitive-Behavioral Intervention, Pain, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Birgul ErdoganUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Intervention Package Group | Experimental | Behavioral: CBIP - Cognitive-Behavioral Intervention PackageBefore 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. |
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBIP - Cognitive-Behavioral Intervention PackageBefore 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). | Behavioural | Cognitive-Behavioral Intervention Package Group |
Primary outcome
Sociodemographic Characteristics Form (SCF)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBIP - Cognitive-Behavioral Intervention Package in people with Cancer Associated Pain, run by Birgul Erdogan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic Characteristics Form (SCF) (time frame: At baseline, prior to intervention (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.