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

Sponsor

Aynur Aytekin Ozdemir (Other)

Overall Status

Completed

CT.gov ID

NCT06018909

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Procedural Anxiety Procedural Pain	Behavioral: Cognitive-Behavioral Interventions Package	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 29, 2018

Actual Primary Completion Date :

Oct 31, 2018

Actual Study Completion Date :

Jun 28, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Visual Analog Scale: VAS [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.
Wong-Baker FACES Pain Rating Scale: WB-FACES [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.
Children's Fear Scale: CFS [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.
State-Trait Anxiety Inventory for Children-State Form (STAIC-State) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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