ShotBloker and Helfer Skin Tap Technique During Intramuscular Injection in Children

NCT05563233 | Completed

• 1 other identifier: 1824
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the effect of the Helfer skin tap technique and ShotBloker application on pain and fear experienced during intramuscular injection in children aged 6-12 in the pediatric emergency unit. It was planned as a randomized controlled experimental study to determine its effect on fear. The population of the study will be children aged 6-12 years who applied to the Tarsus State Hospital, and Pediatric Emergency Clinic and the sample will be 177 children who will undergo intramuscular intervention and meet the criteria for inclusion in the study. In data collection; Data collection form, Wong-Baker Scale, and Child fear scale will be used. In order to examine the mean scores of pain and fear according to intramuscular administration techniques in children, appropriate tests will be used by making an analysis of conformity to normal distribution.

Conditions

Pain, Acute; Fear; Emergencies; Child, Only; Injection Fear

Outcome Measures

Primary Outcomes (5)

• Wong-Baker Scale score

  Wong-Baker Scale (Pain Face Rating Scale): In the Wong-Baker scale, there are faces representing increasing pain severity from left to right, ranging from zero to five. The leftmost face has a smiling expression, indicating a pain-free state, while the right-most face has a crying expression, corresponding to the most severe pain. Below each facial expression is a short description describing the severity of pain: 0 - no pain, 1- a little pain, 2- a little more pain, 3- even more pain, 4- a lot of pain, 5- the most severe pain. Before, during, and 5 minutes after the injection, the pain level of the children in all groups will be re-evaluated.

  1 day

• Child Fear Scale score

  Child Fear Scale: The Child Fear Scale is a scale used to assess the anxiety level of children with 5 face shapes scored between 0-4. 0 = no anxiety, 4 = severe anxiety. Before, during, and 5 minutes after the injection, the fear level of the children in all groups will be re-evaluated.

  1 day

• mean arterial pressure

  The mean arterial pressureof the child was evaluated and recorded before during, and 5 minutes after the injection

  1 day

• heart rate

  The heart rate of the child was evaluated and recorded before during, and 5 minutes after the injection

  1 day

• saturation

  The saturation of the child was evaluated and recorded before during, and 5 minutes after the injection

  1 day

Study Arms (3)

Helfer Skin Tap

EXPERIMENTAL

Helfer Skin Tap (rhythmic tapping of the skin at the injection site to relax the muscles during injection) is an effective method in reducing pain in intramuscular applications in studies performed with the injection technique. Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. During the intramuscular injection to be applied to the ventrogluteal region, the level of pain and fear will be examined using the Helfer skin tap technique. 5 minutes after the injection, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.

Other: Helfer skin tap technique

Shotblocker

EXPERIMENTAL

Shotblocker is a flat, horseshoe-shaped device with short, non-sharp 2 mm thick blunt protrusions that connect with the skin, and a hole in the middle to expose the injection site used to reduce pain during subcutaneous or intramuscular injection applications. Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. During the intramuscular injection to be applied to the ventrogluteal region, the level of pain and fear will be examined by using Shot Blocker. 5 minutes after the injection, the pain and fear levels of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.

Device: Shot Blocker

control group

NO INTERVENTION

Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. The level of pain and fear will be examined during intramuscular injection into the ventrogluteal region without any intervention. 5 minutes after the injection, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.

Interventions

Helfer skin tap technique OTHER

Using the Helfer skin tap technique during intramuscular injection to the ventrogluteal region.

Helfer Skin Tap

Shot Blocker DEVICE

Shot Blocker will be used during intramuscular injection to be applied to the ventrogluteal region.

Shotblocker

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To be 6-12 years old,
• Volunteering to participate in the research,
• Not having a chronic disease, not having a mental or neurological disability,
• Being able to communicate verbally,
• Not taking any medication that has an analgesic effect at least 6 hours before applying to the emergency room.
• Not have a life-threatening (sepsis, shock, respiratory/cardiogenic arrest, etc.) disease

You may not qualify if:

• Not to be between the ages of 6-12,
• Not volunteering to participate in the research,
• Having a chronic disease, mental or neurological disability,
• Taking any analgesic medication at least 6 hours before applying to the emergency room
• Having a life-threatening (sepsis, shock, respiratory/cardiogenic arrest, etc.) disease

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (16)

• 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

• 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

• Aykanat Girgin, B., Aktaş E., Kılınç, D., Gözen, D. (2020). Let's Prefer the Pain Reducing Intervention, Buzzy or ShotBlocker: A Randomized Controlled Trial. Journal of Behçet Uz Children's Hospital, 10(3),290-298.

  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

• 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

• 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

• Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105.

  PMID: 26263287 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

• Emel, T., Nese, C., & Leyla, K. (2017). Effects of ShotBlocker on relief of pain due to Hepatitis B vaccine injection into deltoid muscle. International Journal of Caring Sciences, 10(3), 1669-75

  BACKGROUND

• Jose, R. M., Sulochana, B., & Shetty, S. (2012). Effectiveness of Skin Tap Technique in Reducing Pain Response. International Journal of Nursing Education, 4(1).

  BACKGROUND

• Khanra, S., & Lenka, A. (2018). Helfer Skin Tap Technique on Pain Associated With Intramuscular Injection among Adult Patients. International Journal of Nursing Education, 10(3), 12-17.

  BACKGROUND

• Mahato, E. (2019). Effectiveness of Helfer's Skin Tap Technique Versus Routine Technique on Pain Reduction among Patients Receiving Intramuscular Injections. International Journal of Nursing Education, 11(1),41-44.

  BACKGROUND

• Serena S. Rhythmic skin tapping: an effective measure to reduce procedural pain during IM injection. Nurs J India. 2010 Aug;101(8):178-80. No abstract available.

  PMID: 23520823 BACKGROUND

• Soliman, H. M. M., & Hassnein, A. A. (2016). Efficacy of Helfer skin tapping technique on pain intensity as perceived by the patients receiving intramuscular injection. International Journal of Nursing Didactics, 6(2), 12-22.

  BACKGROUND

• Therese, A. M., & Devi, S. (2014). Effectiveness of Helfer skin tap technique and . routine technique on pain reduction among patients receiving intramuscular injection at Government General Hospital, Puducherry. Int J Sci Res, 3(10).

  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

MeSH Terms

Conditions

Acute Pain; Emergencies; Iatrophobia

Condition Hierarchy (Ancestors)

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

Study Officials

• Duygu Sönmez Düzkaya

  Tarsus University

  PRINCIPAL INVESTIGATOR

• Senem Andı

  Tarsus Univesity

  PRINCIPAL INVESTIGATOR

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: September 6, 2022
• First Posted: October 3, 2022
• Study Start: April 10, 2022
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)