The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination

NCT06312228 | Completed

• 1 other identifier: 2023/05
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023. Data Collection Form, Wong-Baker pain scale, Fear scale and Buzzy® device were used as data collection tools. Buzzy® and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection, while routine vaccine injection was applied to the children in the control group. Children's pain and fear responses were evaluated by the nurse and parents before and after vaccine injection, and physiological parameters were evaluated by the nurse before and after vaccine injection.

Conditions

Child, Only

Keywords

pain; fear; Buzzy; Helfer skin tap teknik

Outcome Measures

Primary Outcomes (3)

• Child Information Form

  The information form has been prepared by reviewing the literature on the subject (Canbulat and Bal 2015; Canbulat et al 2014) and includes the child's age, gender, height, weight, presence of other children in the family, physiological parameters before and after vaccination injection, Wong-Baker pain score, and Fear score evaluated by the nurse, parent, and child before and after the vaccination injection. There are a total of 5 questions in the data collection form.

  1 day

• Wong-Baker Scale (Pain Facial Expression Scale)

  The Wong-Baker scale consists of faces representing increasing levels of pain from zero to five, moving from left to right. The face on the far left has a smiling expression, indicating a pain-free condition, while the face on the far right has a crying expression, representing the most severe pain. Each facial expression is accompanied by a brief description explaining the pain intensity: 0 - no pain, 1 - mild pain, 2 - a bit more pain, 3 - even more pain, 4 - quite a lot of pain, 5 - the most severe pain.

  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

Study Arms (3)

Helper Skin Tap Technique Group

EXPERIMENTAL

Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn.

Other: Helfer Skin Tap

Buzzy Group

EXPERIMENTAL

Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds.

Other: Buzzy

Control Group

NO INTERVENTION

Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. MMR vaccine injection was routinely administered in the area corresponding to the left deltoid muscle without any intervention or application to the injection site.

Interventions

Helfer Skin Tap OTHER

Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn.

Helper Skin Tap Technique Group

Buzzy OTHER

The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds.

Buzzy Group

Eligibility Criteria

• Age: 4 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child being at least 4 years old,
• The administration of the DTP vaccine,
• Being at an appropriate weight for their age,
• The child not having received any analgesic medication during the day,
• The willingness of the parent to participate in the research

You may not qualify if:

• \- Having a neurological illness,
• Having a chronic illness,
• Having an allergy (egg allergy),
• Having a body temperature above 37.5 degrees Celsius

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (8)

• 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

• 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

• 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

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

  BACKGROUND

• Taddio A, McMurtry CM, Shah V, Riddell RP, Chambers CT, Noel M, MacDonald NE, Rogers J, Bucci LM, Mousmanis P, Lang E, Halperin SA, Bowles S, Halpert C, Ipp M, Asmundson GJG, Rieder MJ, Robson K, Uleryk E, Antony MM, Dubey V, Hanrahan A, Lockett D, Scott J, Bleeker EV; HELPinKids&Adults. Reducing pain during vaccine injections: clinical practice guideline. CMAJ. 2015 Sep 22;187(13):975-982. doi: 10.1503/cmaj.150391. Epub 2015 Aug 24. No abstract available.

  PMID: 26303247 BACKGROUND

• Shah V, Taddio A, McMurtry CM, Halperin SA, Noel M, Pillai Riddell R, Chambers CT; HELPinKIDS Team. Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis. Clin J Pain. 2015 Oct;31(10 Suppl):S38-63. doi: 10.1097/AJP.0000000000000281.

  PMID: 26201016 BACKGROUND

• Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. The influence of children's pain memories on subsequent pain experience. Pain. 2012 Aug;153(8):1563-1572. doi: 10.1016/j.pain.2012.02.020. Epub 2012 May 3.

  PMID: 22560288 BACKGROUND

• Koc T, Gozen D. The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2015 Oct;12(5):289-96. doi: 10.1111/wvn.12099. Epub 2015 Jul 28.

  PMID: 26220257 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

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: March 8, 2024
• First Posted: March 15, 2024
• Study Start: May 1, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

TU (1)