Nonpharmacological Methods for Children

NCT05070325 | Completed

• 1 other identifier: BANU-D-YILMAZ-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of the methods of cold application and Shotblocker on the pain and anxiety level of the children in reducing the pain associated with the intramuscular injection. The hypotheses of the study: Hypothesis 0. Shotblocker and the cold application to the injection site prior to the injection are not effective in reducing the pain associated with the intramuscular injection in children. Hypothesis 1. Using ShotBlocker during the intramuscular injection reduces the pain and anxiety experienced by the child. Hypothesis 2. Applying cold to the injection site prior to the intramuscular injection reduces the pain and anxiety experienced by the child. This research was designed as a randomized controlled experimental study in a university hospital in Çorum. The sample of the study comprised 150 children aged 7 to 12 years who were brought to the pediatric injection room in a university hospital and had intramuscular injection. The children were randomized into the Shotblocker (n=50), cold application (n=50) and control (n=50) groups. In addition to Wong-Baker Pain Scale and Child Anxiety Scale, the Child Information Form was used in the study to determine the introductory characteristics of the children and their family.

Conditions

Child; Procedural Anxiety; Procedural Pain

Keywords

Cold application; Intramuscular injection; Pediatric nurse; Shotblocker

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES® Scale

  The WB-FACES was developed by Wong and Baker in 1981 and revised in 1983. 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 (0 = very happy/no pain, 5 = the worst pain imaginable). 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

  The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral (0) to extreme fear (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

Study Arms (3)

Cold application group (Group 1)

EXPERIMENTAL

In the children in this group, the injection site was cleaned before the injection using antiseptic cotton and then the gel pad was placed on the injection site. In line with the literature, the cold gel pad was applied to the intramuscular injection site for 30-45 seconds before the injection and then the injection was delivered. The children were told to breathe deeply and not to tense up during the injection.

Other: Cold application group

Shotblocker group (Group 2)

EXPERIMENTAL

The injection site was cleaned using antiseptic cotton. The surface of the Shotblocker with the contact points was placed on the site just before the injection in a way not to contaminate the injection point. Injection was carried out through the opening in the middle of ShotBlocker. The children were told to breathe deeply and not to tense up during the injection. After the injection was completed, ShotBlocker was removed from the skin.

Other: Shotblocker group

Control Group (Group 3)

EXPERIMENTAL

The routine IM injection was applied to the children in this group. The injection site was cleaned using antiseptic cotton. The children were told to breathe deeply and not to tense up during the injection.

Other: Control Group

Interventions

Cold application group OTHER

Cold application group (Group 1): In the children in this group, the injection site was cleaned before the injection using antiseptic cotton and then the gel pad was placed on the injection site. In line with the literature, the cold gel pad was applied to the intramuscular injection site for 30-45 seconds before the injection and then the injection was delivered. The children were told to breathe deeply and not to tense up during the injection.

Cold application group (Group 1)

Shotblocker group OTHER

Shotblocker group (Group 2): The injection site was cleaned using antiseptic cotton. The surface of the Shotblocker with the contact points was placed on the site just before the injection in a way not to contaminate the injection point. Injection was carried out through the opening in the middle of ShotBlocker. The children were told to breathe deeply and not to tense up during the injection. After the injection was completed, ShotBlocker was removed from the skin.

Shotblocker group (Group 2)

Control Group OTHER

Control Group (Group 3): The routine IM injection was applied to the children in this group. The injection site was cleaned using antiseptic cotton. The children were told to breathe deeply and not to tense up during the injection.

Control Group (Group 3)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• were in the age group of 7-12 years
• due to IM injection (penicilline (procaine penicilline)

You may not qualify if:

• had developmental retardation/disability
• had communication difficulty
• had no chronic disease
• had a history of analgesic drug within the last 6 hours

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Hitit University- Hitit Medical Faculty Hospital Pediatrics Clinic

Çorum, 19040, Turkey (Türkiye)

Location

Related Publications (13)

• Hunseler C, Roth B, Pothmann R, Reinhold P. [Intramuscular injections in children]. Schmerz. 2005 Apr;19(2):140-3. doi: 10.1007/s00482-004-0318-2. German.

  PMID: 15004746 BACKGROUND

• Aydin E, Avsar G. Examining the effect of "Shotblocker" in relieving pain associated with intramuscular injection. Complement Ther Med. 2019 Dec;47:102192. doi: 10.1016/j.ctim.2019.09.001. Epub 2019 Sep 3.

  PMID: 31779992 BACKGROUND

• Sanlialp Zeyrek A, Takmak S, Kurban NK, Arslan S. Systematic review and meta-analysis: Physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019 Dec;75(12):3346-3361. doi: 10.1111/jan.14183. Epub 2019 Sep 13.

  PMID: 31452229 BACKGROUND

• Bilge S, Aydin A, Gun C, Aldinc H, Acar YA, Yaylaci S, Cinar O, Balci V. Comparison of the efficacy of ShotBlocker and cold spray in reducing intramuscular injection-related pain in adults. A prospective, randomized, controlled trial. Saudi Med J. 2019 Oct;40(10):996-1002. doi: 10.15537/smj.2019.10.24322.

  PMID: 31588477 BACKGROUND

• Canbulat Sahiner N, Turkmen AS. The Effect of Distraction Cards on Reducing Pain and Anxiety During Intramuscular Injection in Children. Worldviews Evid Based Nurs. 2019 Jun;16(3):230-235. doi: 10.1111/wvn.12359. Epub 2019 Apr 17.

  PMID: 30997744 BACKGROUND

• Yilmaz G, Alemdar DK. Using Buzzy, Shotblocker, and Bubble Blowing in a Pediatric Emergency Department to Reduce the Pain and Fear Caused by Intramuscular Injection: A Randomized Controlled Trial. J Emerg Nurs. 2019 Sep;45(5):502-511. doi: 10.1016/j.jen.2019.04.003. Epub 2019 Jun 27.

  PMID: 31257044 BACKGROUND

• Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.

  PMID: 30284240 BACKGROUND

• Gad RF, Dowling DA, Abusaad FE, Bassiouny MR, Abd El Aziz MA. Oral Sucrose Versus Breastfeeding in Managing Infants' Immunization-Related Pain: A Randomized Controlled Trial. MCN Am J Matern Child Nurs. 2019 Mar/Apr;44(2):108-114. doi: 10.1097/NMC.0000000000000512.

  PMID: 30807328 BACKGROUND

• Canbulat Sahiner N, Turkmen AS, Acikgoz A, Simsek E, Kirel B. Effectiveness of Two Different Methods for Pain Reduction During Insulin Injection in Children With Type 1 Diabetes: Buzzy and ShotBlocker. Worldviews Evid Based Nurs. 2018 Dec;15(6):464-470. doi: 10.1111/wvn.12325. Epub 2018 Oct 11.

  PMID: 30307692 BACKGROUND

• Sivri Bilgen B, Balci S. The Effect on Pain of Buzzy(R) and ShotBlocker(R) during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. J Korean Acad Nurs. 2019 Aug;49(4):486-494. doi: 10.4040/jkan.2019.49.4.486.

  PMID: 31477677 BACKGROUND

• ENA Clinical Practice Guideline Committee; ENA Board of Directors Liaisons:; Methodologist:; Staff Liaisons:; Administrative Staff:. Clinical Practice Guideline: Needle-Related or Minor Procedural Pain in Pediatric Patients. J Emerg Nurs. 2019 Jul;45(4):437.e1-437.e32. doi: 10.1016/j.jen.2019.05.015. No abstract available.

  PMID: 31280767 BACKGROUND

• Cobb JE, Cohen LL. A randomized controlled trial of the ShotBlocker for children's immunization distress. Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.

  PMID: 19851160 BACKGROUND

• Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.

  PMID: 28437308 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Selen OZAKAR AKÇA, PhD, RN, Associate Professor

  Hitit University

  STUDY CHAIR

• Havva Nur PELTEK KENDİRCİ, PhD, MD, Associate Professor

  Hitit University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Associate Professor

Model Details: Prospective, randomized controlled trial

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 7, 2021
• Study Start: November 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 20, 2018
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

TU (1)