Procedural AnxietyNCT06018909
The Effect of Cognitive-Behavioral Intervention Package on Procedural Pain and Anxiety in Children
A study testing Cognitive-Behavioral Interventions Package in people with Procedural Anxiety and Procedural Pain, run by Aynur Aytekin Ozdemir at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the effect of cognitive-behavioral interventions package (CBIP) on pain and anxiety related to peripheral venous cannulation (PVC) in children aged 7-12 years. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Anxiety, Procedural Pain
- What is being tested?
- Cognitive-Behavioral Interventions Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2018to 28 Jun 2019
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being between the ages of 7 to 12 years
- be literate
- requiring peripheral venous cannulation procedure
Who cannot join
- had chronic diseases
- had neuro-developmentally delayed
- had visual, audio, or speech impairments
- were hospital stay for treatment in the past three years
- had a history of sedative, analgesic or narcotic use within 24 hours before procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Kadıköy, 34720
About this study
Official title: The Effect of Cognitive-Behavioral Intervention Package on Peripheral Venous Cannulation Pain and Anxiety in Children: A Randomized Controlled Trial
This study investigated the effect of cognitive-behavioral interventions package (CBIP) on pain and anxiety related to peripheral venous cannulation (PVC) in children aged 7-12 years.
Read the detailed description
The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods can be used especially in acute settings. Cognitive-behavioral interventions, one of the non-pharmacological methods used to minimize pain and anxiety related to painful medical procedures in children are promising.
- Conditions
- Procedural Anxiety, Procedural Pain
- Being tested
- Cognitive-Behavioral Interventions Package
- Keywords
- Anxiety, Children, Procedural pain, Cognitive-behavioral interventions
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Interventions PackageBehavioural
CBIP was developed by researchers in line with the relevant literature according to the developmental characteristics of children. Opinions were obtained from experts in the field of pediatrics or psychiatric nursing regarding CBIP. CBIP consisted of cognitive and behavioral practices to prevent/reduce procedural pain and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Interventions Package Group | Experimental | Participants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement. Receives: Behavioral: Cognitive-Behavioral Interventions Package |
| Control | No intervention | The control group received the routine peripheral venous cannulation procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale: VAS
The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over.
Measured: Through painful procedure completion, an average of 10 minutes
Wong-Baker FACES Pain Rating Scale: WB-FACES
The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.
Measured: Through painful procedure completion, an average of 10 minutes
Children's Fear Scale: CFS
The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures.
Measured: Through painful procedure completion, an average of 10 minutes
State-Trait Anxiety Inventory for Children-State Form (STAIC-State)
STAIC was designed as a research tool for the study of anxiety in 9- to 12-year-old children as well as in younger or older children depending on their reading ability. The widely used STAIC-State Form includes 20-item self-report scale situational variation. In the STAIC-State Form, the children were asked to evaluate how they felt "that moment" and mark one of the relevant choices. When the presence of these feelings is stated as "much" by the child, the highest score is 3; and when it is not stated, the lowest score is 1.
Measured: Through painful procedure completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start29 Mar 2018
- Primary completion31 Oct 2018
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies 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
- Model description
- Participants were randomized into the experimental and control groups using a block randomization method. The variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aynur Aytekin Ozdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Özdemir, PhD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018909
- Sponsor's protocol ID
- 2018-3/20
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Hsieh YC, Cheng SF, Tsay PK, Su WJ, Cho YH, Chen CW. Effectiveness of Cognitive-behavioral Program on Pain and Fear in School-aged Children Undergoing Intravenous Placement. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec;11(4):261-267. doi: 10.1016/j.anr.2017.10.002. Epub 2017 Oct 26.
PubMed 29290273McCarthy AM, Cool VA, Hanrahan K. Cognitive behavioral interventions for children during painful procedures: research challenges and program development. J Pediatr Nurs. 1998 Feb;13(1):55-63. doi: 10.1016/S0882-5963(98)80069-9.
PubMed 9503767Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.
PubMed 24108531Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
PubMed 18387963Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 Oct 15.
PubMed 31628067Demir Imamoglu Z, Aytekin Ozdemir A. The effect of a cognitive behavioural intervention package on peripheral venous cannulation pain, fear and anxiety in Paediatric patients: A randomised controlled trial. J Pediatr Nurs. 2024 May-Jun;76:192-198. doi: 10.1016/j.pedn.2024.02.003. Epub 2024 Feb 28.
PubMed 38417207
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive-Behavioral Intervention Package on Peripheral Venous Cannulation Pain and Anxiety in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06018909
- Acronym / sponsor ID
- 2018-3/20
- Conditions
- Procedural Anxiety, Procedural Pain
- Keywords
- Anxiety, Children, Procedural pain, Cognitive-behavioral interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aynur Aytekin OzdemirUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 31 Aug 2023 (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 investigated the effect of cognitive-behavioral interventions package (CBIP) on pain and anxiety related to peripheral venous cannulation (PVC) in children aged 7-12 years.
Detailed description
The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods can be used especially in acute settings. Cognitive-behavioral interventions, one of the non-pharmacological methods used to minimize pain and anxiety related to painful medical procedures in children are promising.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants were randomized into the experimental and control groups using a block randomization method. The variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization.
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Interventions Package Group | Experimental | Behavioral: Cognitive-Behavioral Interventions PackageParticipants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement. |
| Control | No intervention | –The control group received the routine peripheral venous cannulation procedure. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being between the ages of 7 to 12 years
- be literate
- requiring peripheral venous cannulation procedure
Key exclusion criteria (5 listed)
- had chronic diseases
- had neuro-developmentally delayed
- had visual, audio, or speech impairments
- were hospital stay for treatment in the past three years
- had a history of sedative, analgesic or narcotic use within 24 hours before 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 |
|---|---|---|
| Cognitive-Behavioral Interventions PackageCBIP was developed by researchers in line with the relevant literature according to the developmental characteristics of children. Opinions were obtained from experts in the field of pediatrics or psychiatric nursing regarding CBIP. CBIP consisted of cognitive and behavioral practices to prevent/reduce procedural pain and anxiety. | Behavioural | Cognitive-Behavioral Interventions Package Group |
Primary outcome
Visual Analog Scale: VAS
Time frame: Through painful procedure completion, an average of 10 minutes
The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over.
Wong-Baker FACES Pain Rating Scale: WB-FACES
Time frame: Through painful procedure completion, an average of 10 minutes
The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.
Children's Fear Scale: CFS
Time frame: Through painful procedure completion, an average of 10 minutes
The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures.
State-Trait Anxiety Inventory for Children-State Form (STAIC-State)
Time frame: Through painful procedure completion, an average of 10 minutes
STAIC was designed as a research tool for the study of anxiety in 9- to 12-year-old children as well as in younger or older children depending on their reading ability. The widely used STAIC-State Form includes 20-item self-report scale situational variation. In the STAIC-State Form, the children were asked to evaluate how they felt "that moment" and mark one of the relevant choices. When the presence of these feelings is stated as "much" by the child, the highest score is 3; and when it is not stated, the lowest score is 1.
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 31 Aug 2023.
- Results publication: PubMed 29290273Hsieh YC, Cheng SF, Tsay PK, Su WJ, Cho YH, Chen CW. Effectiveness of Cognitive-behavioral Program on Pain and Fear in School-aged Children Undergoing Intravenous Placement. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec;11(4):261-267. doi: 10.1016/j.anr.2017.10.002. Epub 2017 Oct 26.
- Results publication: PubMed 9503767McCarthy AM, Cool VA, Hanrahan K. Cognitive behavioral interventions for children during painful procedures: research challenges and program development. J Pediatr Nurs. 1998 Feb;13(1):55-63. doi: 10.1016/S0882-5963(98)80069-9.
- Results publication: PubMed 24108531Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.
- Results publication: PubMed 18387963Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
- Results publication: PubMed 31628067Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 Oct 15.
- Derived from this study: PubMed 38417207Demir Imamoglu Z, Aytekin Ozdemir A. The effect of a cognitive behavioural intervention package on peripheral venous cannulation pain, fear and anxiety in Paediatric patients: A randomised controlled trial. J Pediatr Nurs. 2024 May-Jun;76:192-198. doi: 10.1016/j.pedn.2024.02.003. Epub 2024 Feb 28.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
Aynur Aytekin Özdemir, PhD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Interventions Package in people with Procedural Anxiety and Procedural Pain, run by Aynur Aytekin Ozdemir 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 3 inclusion and 5 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 31 Aug 2023. 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?
Visual Analog Scale: VAS (time frame: Through painful procedure completion, an average of 10 minutes). 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?
On the ClinicalTrials.gov record for NCT06018909, which also lists 6 linked publications.
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 31 Aug 2023.