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

Primary Purpose

Procedural Anxiety, Procedural Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive-Behavioral Interventions Package
Sponsored by
Aynur Aytekin Ozdemir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Anxiety focused on measuring Anxiety, Children, Procedural pain, Cognitive-behavioral interventions

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medeniyet University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive-Behavioral Interventions Package Group

Control

Arm Description

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

The control group received the routine peripheral venous cannulation procedure.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2023
Last Updated
August 30, 2023
Sponsor
Aynur Aytekin Ozdemir
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1. Study Identification

Unique Protocol Identification Number
NCT06018909
Brief Title
The Effect of Cognitive-Behavioral Intervention Package on Procedural Pain and Anxiety in Children
Official Title
The Effect of Cognitive-Behavioral Intervention Package on Peripheral Venous Cannulation Pain and Anxiety in Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aynur Aytekin Ozdemir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Anxiety, Procedural Pain
Keywords
Anxiety, Children, Procedural pain, Cognitive-behavioral interventions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Interventions Package Group
Arm Type
Experimental
Arm Description
Participants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group received the routine peripheral venous cannulation procedure.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Interventions Package
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale: VAS
Description
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.
Time Frame
Through painful procedure completion, an average of 10 minutes
Title
Wong-Baker FACES Pain Rating Scale: WB-FACES
Description
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.
Time Frame
Through painful procedure completion, an average of 10 minutes
Title
Children's Fear Scale: CFS
Description
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.
Time Frame
Through painful procedure completion, an average of 10 minutes
Title
State-Trait Anxiety Inventory for Children-State Form (STAIC-State)
Description
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.
Time Frame
Through painful procedure completion, an average of 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aynur Aytekin Özdemir, PhD
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
State/Province
Kadıköy
ZIP/Postal Code
34720
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
29290273
Citation
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.
Results Reference
result
PubMed Identifier
9503767
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.
Results Reference
result
PubMed Identifier
24108531
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: 10.1002/14651858.CD005179.pub3.
Results Reference
result
PubMed Identifier
18387963
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 Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
Results Reference
result
PubMed Identifier
31628067
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 Oct 15.
Results Reference
result

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

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