The Effect of Cold Spray and Ice Applied During Intravenous Access on Pain and Fear i in Pediatric Emergency Unit

NCT06109298 | Completed

• 1 other identifier: 347
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Many strategies have been developed for the prevention of to prevent procedural pain in pediatric emergency units where nurses play a vital role in patient comfort.Easy-to-use and inexpensive nonpharmacologic analgesic methods are important in emergency units.This study was conducted to determine the effect of cold spray and ice applied during venipuncture on the level of fear and pain in children ages 7-15. This randomized, controlled experimental study was conducted in the Pediatric Emergency Clinic of Istanbul Gaziosmanpaşa Training and Research Hospital between November 2021 7 and April 2022. The study was conducted with 96 children between the ages of 7 and 15 (cold spray group, ice group, and control group) who were scheduled to have venous access in the pediatric emergency clinic and met the sampling criteria. The Pediatric Emergency Clinic consists of 10 beds. Patients with complaints such as fever, vomiting, diarrhea, and seizures comprise the majority of those admitted to the clinic. In the Pediatric Emergency Clinic, intravenous interventions were performed in the injection room.

Conditions

Children, Only; Pain; Emergencies

Keywords

ıce pack; cold spray; fear; pain

Outcome Measures

Primary Outcomes (3)

• Data Collection Form

  The data collection form was prepared by reviewing the literature on the subject. It consisted of a total of 15 questions, including questions about the child's and family's descriptive characteristics (such as age and gender), the reason for going to the emergency room, and complaints, such as previous emergency room visits

  1 day

• Child Fear Scale

  The Child Fear Scale is used to assess the anxiety levels of children with five face shapes scored between 0-4: 0 = no anxiety, and 4 = severe anxiety. The scale can be evaluated by both the child and the researcher before, during, and after the intervention.

  1 day

• Visual Analog Scale

  The VAS is the most frequently used scale in pain studies. In children over 7 years of age, it is frequently used because it is common and easy. The VAS is a pain scale with numbers from 1 to 10, equally spaced on a 10 cm horizontal ruler. Children being assessed are asked to choose a pain value between 1 and 10 on this ruler.

  1 day

Study Arms (3)

First study group

EXPERIMENTAL

Before performing intravenous intervention, cold spray was applied for 5 seconds at a distance of 15 cm to an area of approximately 5 cm2 at the site of the procedure. After tourniquet fixation and subsequent skin disinfection for 60 seconds, the nurse researcher performed intravenous administration.

Other: Cold spray

Second study group

EXPERIMENTAL

Before the intravenous intervention, refrigerated gel ice was applied for 5 minutes at 2 cm above the area to be treated. After that, the nurse removed the gel ice from the procedure area, a tourniquet was applied, and skin disinfection was performed for 60 seconds. The nurse researcher performed intravenous administration.

Other: Refrigerated gel ice

Control group

NO INTERVENTION

No pharmacologic or nonpharmacologic application was performed. The researcher performed intravenous access after skin disinfection by the nurse.

Interventions

Cold spray OTHER

Cold spray was applied for 5 seconds at a distance of 15 cm to an area of approximately 5 cm2 at the site of the procedu

First study group

Refrigerated gel ice OTHER

Refrigerated gel ice was applied for 5 minutes at 2 cm above the area to be treated.

Second study group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children included in the study were 7-15 years old
• volunteered to participate
• Had no chronic diseases, mental or neurological disabilities, neurodevelopmental impairments, or life threatening conditions (sepsis, shock, respiratory/cardiogenic arrest, etc.).

You may not qualify if:

• Children who had taken any analgesic medication before presentation to the emergency department
• had undergone multiple attempts for vascular access

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (9)

• Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.

  PMID: 33939726 BACKGROUND

• Su HC, Hsieh CW, Lai NM, Chou PY, Lin PH, Chen KH. Using Vibrating and Cold Device for Pain Relieves in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Pediatr Nurs. 2021 Nov-Dec;61:23-33. doi: 10.1016/j.pedn.2021.02.027. Epub 2021 Mar 16.

  PMID: 33735633 BACKGROUND

• Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.

  PMID: 29728296 BACKGROUND

• Canbulat Sahiner N, Inal S, Sevim Akbay A. The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety levels in children. J Perianesth Nurs. 2015 Jun;30(3):228-35. doi: 10.1016/j.jopan.2014.05.011.

  PMID: 26003770 BACKGROUND

• Inal S, Kelleci M. The Effect of External Thermomechanical Stimulation and Distraction on Reducing Pain Experienced by Children During Blood Drawing. Pediatr Emerg Care. 2020 Feb;36(2):66-69. doi: 10.1097/PEC.0000000000001264.

  PMID: 28885392 BACKGROUND

• Potts DA, Davis KF, Elci OU, Fein JA. A Vibrating Cold Device to Reduce Pain in the Pediatric Emergency Department: A Randomized Clinical Trial. Pediatr Emerg Care. 2019 Jun;35(6):419-425. doi: 10.1097/PEC.0000000000001041.

  PMID: 28121978 BACKGROUND

• Redfern RE, Micham J, Sievert D, Chen JT. Effects of Thermomechanical Stimulation During Intravenous Catheter Insertion in Adults: A Prospective Randomized Study. J Infus Nurs. 2018 Sep/Oct;41(5):294-300. doi: 10.1097/NAN.0000000000000294.

  PMID: 30188451 BACKGROUND

• Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.

  PMID: 30253890 BACKGROUND

• Mu Y, Wang L. Standardized post-catheter nursing intervention reduces incidence of catheter complications in the disabled elderly and improves their quality of life. Am J Transl Res. 2021 Nov 15;13(11):12957-12964. eCollection 2021.

  PMID: 34956511 BACKGROUND

MeSH Terms

Conditions

Pain; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)