Clinical trial NCT05563233: ShotBloker and Helfer Skin Tap Technique During Intramuscular Injection in Children
Official title: The Effect of ShotBloker and Helfer Skin Tap Technique on Pain and Fear During Intramuscular Injection in Children Aged 6-12 in the Pediatric Emergency Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Fear
Emergencies
Child, Only
Injection Fear
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 177
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Pain is an experience of complex perceptions that overwhelms the patient, distorts their behavior and thoughts, prompts them to perform activities that require immediate attention and aim to stop the pain, and causes behavioral reactions and automatic changes.

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.

Type of Study: It was planned as a randomized controlled experimental study to determine the effect of Helfer skin tap technique and Shot Blocker application on pain and fear experienced during intramuscular injection in children aged 6-12 years who applied to the pediatric emergency clinic.

Research Population and Sample Selection The population of the study will be children aged 6-12 years who applied to the Tarsus State Hospital, Pediatric Emergency Clinic, and the sample will be 177 children who will undergo intramuscular intervention, meeting the criteria for inclusion in the research. According to the results of the G-power analysis for the sample size, in accordance with the literature of Canbulat and Bal (2015), Canbulat et al (2014) and Mutlu (2012) to find a medium power effect size difference of 0.25 between the groups, type I error 0.05, power of the test. While 0.80 (α= 0.05, β= 0.20), the minimal sample size was 177 (n=59 for each group).

Data collection Stages of Research Stage 1: A pilot study will be conducted with 20 children in order to evaluate the appropriateness of the forms and scales used before the research.

Stage 2: The purpose of the research and how to record the data will be explained to the nurse who will administer the intramuscular injection procedure using the ventrogluoteal region and to the nurse who will observe the child's pain and fear during the procedure. The children in the sample group and their parents will be informed about the path followed in practice and the research, and their verbal and written consent will be obtained.

Stage 3: The patients who meet the sample selection criteria will be randomly and equally distributed into 3 groups through a program in the computer environment, and randomization will be provided.

(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html) (1st experimental group Helfer skin tap technique suitable group, 2nd experimental group Shot Blocker group, 3rd group control group) Children in each group will be provided with their parents.

Stage 4: The nurse observing the children in all groups before the procedure will fill in the demographic data form, measure the child's pulse, 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.

Stage 5: Intramuscular injection will be given to the ventrogluoteal region by following the procedure steps for the children in all groups. The intramuscular injection procedure will be performed by the same nurse. During the procedure, the child's pain and fear will be observed by the observing nurse and recorded in the observation form.

At this stage;

* First Experimental group; During the intramuscular injection to be applied to the ventrogluoteal region, the level of pain and fear will be examined using the Helfer skin tap technique.
* Second Experiment group; During the intramuscular injection to be applied to the ventrogluoteal region, the level of pain and fear will be examined by using Shot Blocker.
* To the control group; The level of pain and fear will be examined during intramuscular injection into the ventrogluotealregion without any intervention.

Stage 6: 5 minutes after the procedure, 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.

Stage 7: The analysis and reporting of the obtained data will be done.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Wong-Baker Scale score
timeFrame: 1 day
measure: Child Fear Scale score
timeFrame: 1 day
measure: mean arterial pressure
timeFrame: 1 day
measure: heart rate
timeFrame: 1 day
measure: saturation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus State Hospital
Study officials:
affiliation: Tarsus University
name: Duygu Sönmez Düzkaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarsus Univesity
name: Senem Andı
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Jose, R. M., Sulochana, B., & Shetty, S. (2012). Effectiveness of Skin Tap Technique in Reducing Pain Response. International Journal of Nursing Education, 4(1).
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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).
citation: 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.