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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Interventions Package Group | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Interventions Package | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aynur Aytekin Özdemir, PhD | Istanbul Medeniyet University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medeniyet University | Istanbul | Kadıköy | 34720 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29290273 | Result | 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. | |
| 9503767 | Result | McCarthy 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. |
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It will be shared after the article is published.
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Through painful procedure completion, an average of 10 minutes |
| 24108531 | Result | Uman 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. |
| 18387963 | Result | Uman 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. |
| 31628067 | Result | Yilmaz 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. |
| 38417207 | Derived | Demir 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. |
| D001523 | Mental Disorders |