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

NCT06018909 | Completed

• 1 other identifier: 2018-3/20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Procedural Anxiety; Procedural Pain

Keywords

Anxiety; Children; Procedural pain; Cognitive-behavioral interventions

Outcome Measures

Primary Outcomes (4)

• 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.

  Through painful procedure completion, an average of 10 minutes

Study Arms (2)

Cognitive-Behavioral Interventions Package Group

EXPERIMENTAL

Participants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement.

Behavioral: Cognitive-Behavioral Interventions Package

Control

NO INTERVENTION

The control group received the routine peripheral venous cannulation procedure.

Interventions

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.

Cognitive-Behavioral Interventions Package Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• being between the ages of 7 to 12 years
• be literate
• requiring peripheral venous cannulation procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Aynur Aytekin Ozdemir: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 29290273 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.

  PMID: 9503767 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.

  PMID: 24108531 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.

  PMID: 18387963 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.

  PMID: 31628067 RESULT

• 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.

  PMID: 38417207 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 31, 2023
• Study Start: March 29, 2018
• Primary Completion: October 31, 2018
• Study Completion: June 28, 2019
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)