The Effect of Cognitive-Behavioral Intervention Package on Procedural Pain and Anxiety in Children

Procedural Pain Clinical Trial

Official title:

The Effect of Cognitive-Behavioral Intervention Package on Peripheral Venous Cannulation Pain and Anxiety in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06018909
• Other study ID #: 2018-3/20
• Status: Completed
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2023
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 28, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• being between the ages of 7 to 12 years

• be literate

• requiring peripheral venous cannulation procedure

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Pain, Procedural
• Procedural Anxiety
• Procedural Pain

Intervention

Behavioral:
• Cognitive-Behavioral Interventions Package
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	Istanbul	Kadiköy

Sponsors (1)

Lead Sponsor	Collaborator
Aynur Aytekin Ozdemir

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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: 10.1002/1465185 — View Citation

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 Ps — View Citation

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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.	Through painful procedure completion, an average of 10 minutes