Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06018909
Other study ID # 2018-3/20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2018
Est. completion date June 28, 2019

Study information

Verified date August 2023
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 28, 2019
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Istanbul Medeniyet University Istanbul Kadiköy

Sponsors (1)

Lead Sponsor Collaborator
Aynur Aytekin Ozdemir

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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: 10.1002/1465185 — View 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 Ps — View 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 O — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Completed NCT00694174 - Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants Phase 4
Completed NCT06264960 - The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography N/A
Recruiting NCT06354608 - The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children N/A
Completed NCT05073497 - Efficacy of Finger Puppet as a Distraction Method N/A
Recruiting NCT05275881 - Impact of Virtual Reality in Pediatric Hematology and Oncology N/A
Completed NCT05656677 - Parental Involvement in Pain Reducing Measures N/A
Completed NCT04257019 - Pain, Anxiety During Interventional Spine Procedures N/A
Completed NCT05166551 - Effect of Acupressure on Interventional Pain in Infants N/A
Completed NCT04421430 - Nonpharmacological Methods for Children in Procedural Pain N/A
Completed NCT06380556 - The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates N/A
Not yet recruiting NCT05555498 - Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment N/A
Completed NCT03985930 - Non-immersive Virtual Reality for Pediatric Pain Management N/A
Completed NCT05179291 - Efficacy of VR and Buzzy on Pain and Anxiety N/A
Completed NCT05070325 - Nonpharmacological Methods for Children N/A
Completed NCT00150189 - Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations N/A
Completed NCT04254081 - Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion Phase 4
Recruiting NCT05895383 - Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy Phase 4
Not yet recruiting NCT06373627 - Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease N/A
Recruiting NCT04967118 - Neonatal Pain Management and Pain Monitoring Using New Methods N/A