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

August 30, 2023 updated by: Aynur Aytekin Ozdemir

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kadıköy
      • Istanbul, Kadıköy, Turkey, 34720
        • İstanbul medeniyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive-Behavioral Interventions Package Group
Participants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement.
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.
No Intervention: Control
The control group received the routine peripheral venous cannulation procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through painful procedure completion, an average of 10 minutes
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.
Through painful procedure completion, an average of 10 minutes
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.
Through painful procedure completion, an average of 10 minutes
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.
Through painful procedure completion, an average of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aynur Aytekin Ozdemir

Investigators

  • Principal Investigator: Aynur Aytekin Özdemir, PhD, İstanbul medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Estimated)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-3/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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