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

NCT ID: NCT06018909

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2019-06-28

Brief Summary

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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

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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.

Conditions

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Procedural Anxiety Procedural Pain

Keywords

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Anxiety Children Procedural pain Cognitive-behavioral interventions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cognitive-Behavioral Interventions Package Group

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

Group Type EXPERIMENTAL

Cognitive-Behavioral Interventions Package

Intervention Type 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.

Control

The control group received the routine peripheral venous cannulation procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aynur Aytekin Ozdemir

OTHER

Sponsor Role lead

Responsible Party

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Aynur Aytekin Ozdemir

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aynur Aytekin Özdemir, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Locations

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Istanbul Medeniyet University

Istanbul, Kadıköy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 29290273 (View on PubMed)

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.

Reference Type RESULT
PMID: 9503767 (View on PubMed)

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.

Reference Type RESULT
PMID: 24108531 (View on PubMed)

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.

Reference Type RESULT
PMID: 18387963 (View on PubMed)

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.

Reference Type RESULT
PMID: 31628067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38417207 (View on PubMed)

Other Identifiers

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2018-3/20

Identifier Type: -

Identifier Source: org_study_id