Pain and Fear During Intravenous Blood Collection in Children

NCT06044701 | Completed DMC

• 1 other identifier: EU-SBE-CO-01
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Medical procedures can cause significant stress and anxiety for children and parents, impacting their overall hospital experience. Numerous studies have demonstrated that techniques aimed at diverting attention during procedures can effectively reduce pain and fear. Considering the rapid advancements in technology and the strong connection between Generation Z children and technology, this study aims to explore the use of hologram technology through a hologram fan and the traditional method of bubble blowing as interventions to assess their impact on pain and fear levels during intravenous blood collection in children. The study design will follow a randomized controlled trial approach. The sample will consist of patients between the ages of 3 and 12 who meet the sampling criteria and receive outpatient care at the pediatric stem cell outpatient treatment unit between April 2022 and February 2024. Data will be collected using a researcher-prepared form containing introductory information and child pain, fear, and emotional indicator scales for which appropriate permissions have been obtained. The blood collection process will be performed by the unit's nurse, and the observer nurse will complete the scales. Descriptive statistics, such as mean, standard deviation (median, minimum, maximum), frequency, and percentage values, will be used for data analysis. IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) will be employed for data analysis. A significance level of 0.05 will be used for all statistical analyses. Regenerate response Keywords: Fear, pain, pediatrics, hologram, bubble-blowing, invasive procedures

Conditions

Procedural Pain

Keywords

fear; pain; pediatrics; hologram; bubble-blowing; invasive procedures

Outcome Measures

Primary Outcomes (3)

• The Child Fear Scale

  Child Fear Scale (CSS) was used. This scale is a single-item self-report measure used to measure pain-related fear in children. This single-item scale consists of five gender-neutral facets. It ranges from a fearless (neutral) face on the far left to a face showing extreme fear on the far right. The evaluator's response indicates the level of fear. It can be used by parents and researchers before and during the procedure in children aged 5-10 years. CFS was applied to the children by the researcher to evaluate their fear levels regarding blood collection before, during and after the blood collection procedure.

  an average of 6 months

• Wong Baker Pain Scale

  Wong-Baker FACES (WB-FACES) Pain Rating Scale was used. This scale is used to rate pain intensity in children ages 3 and older. This numerical rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = very painful). This scale was evaluated by the researcher during and after blood collection in this study.

  an average of 6 months

• Emotional Indicators Scale

  The Emotional Indicators Scale is used to assess the child's emotional reactions immediately after the needle enters the skin during blood collection. The scale measures emotional indicators such as crying, facial expressions, and distress, with ratings ranging from 0-5 (with 0 indicating no emotional response and 5 representing a strong emotional response). Higher scores on the scale may indicate a worse outcome in terms of emotional distress.This scale was evaluated by the researcher during blood collection in this study.

  an average of 6 months

Study Arms (3)

Hologram fan

ACTIVE COMPARATOR

Hologram fan application during blood collection process

Other: Hologram Distraction Technique

Bubble machine

ACTIVE COMPARATOR

Bubble machine application during blood collection

Other: Bubble Machine Distraction Technique

Control Group

NO INTERVENTION

Performing routine application during the blood collection process

Interventions

Hologram Distraction Technique OTHER

Hologram fan application during blood collection process

Also known as: Hologram Fan

Hologram fan

Bubble Machine Distraction Technique OTHER

Bubble machine application during blood collection

Also known as: Bubble machine

Bubble machine

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient who needs to take intravenous blood
• The participant is in the 3-12 age group

You may not qualify if:

• Failure to obtain consent
• The child has an intellectual or neurological disability
• Failure to communicate in Turkish
• Having visual and hearing impairment
• The child has complaints such as pain, nausea, vomiting, etc. that disrupt his comfort due to another reason.
• hours before the use of analgesic or sedative drugs
• Lack of healthy skin integrity
• Having repeated attempts
• Having syncope during blood collection

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35000, Turkey (Türkiye)

Location

Related Publications (31)

• Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.

  PMID: 30711327 BACKGROUND

• Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.

  PMID: 29237632 BACKGROUND

• Ballard A, Khadra C, Adler S, Doyon-Trottier E, Le May S. Efficacy of the Buzzy(R) device for pain management of children during needle-related procedures: a systematic review protocol. Syst Rev. 2018 May 22;7(1):78. doi: 10.1186/s13643-018-0738-1.

  PMID: 29788987 BACKGROUND

• Binay S, Bilsin E, Gerceker GO, Kahraman A, Bal-Yilmaz H. Comparison of the Effectiveness of Two Different Methods of Decreasing Pain During Phlebotomy in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2019 Aug;34(4):749-756. doi: 10.1016/j.jopan.2018.11.010. Epub 2019 Feb 20.

  PMID: 30797673 BACKGROUND

• Burunsuz E.G, Köse S. (2020). The effect of butterfly patterned detection material used in intravenous catheter application on emotional and physiological indicators of children. Online Turkish Journal of Health Sciences, 5(4), (p:673-682).

  BACKGROUND

• Çalış, H., Karataş, P. (2019). Atraumatic care approach in pediatric nursing: non-pharmacological applications in reducing pain, stress and anxiety. Koç University Journal of Education and Research in Nursing, 16 (3): (p:234-245). DOI:10.5222/HEAD.2019.234

  BACKGROUND

• Çantaş Ayar, A. (2018). White noise during the process of taking blood from the heel of the foot in newborns, the effect of the position of the fetus in the lap and the fetal position given by hand on pain. Master's Thesis. Trabzon.

  BACKGROUND

• Dalley JS, McMurtry CM. Teddy and I Get a Check-Up: A Pilot Educational Intervention Teaching Children Coping Strategies for Managing Procedure-Related Pain and Fear. Pain Res Manag. 2016;2016:4383967. doi: 10.1155/2016/4383967. Epub 2016 Apr 7.

  PMID: 27445612 BACKGROUND

• Dincer, A. (2017). Fear: Language, Conceptualization, Cultural Dimension. International Journal of Turkish Literature Culture and Education, 6(2), (p:769-798).

  BACKGROUND

• Dumandag, F. (2019). Evaluation of the effect of pre-procedure education on the compliance and anxiety level of the upper gastrointestinal tract endoscopy. Biruni University Institute of Health Sciences Department of Nursing Master's Program. Istanbul.

  BACKGROUND

• Engin, M. (2020). A study to determine student opinions on the use of hologram technology in accounting education. Burdur Mehmet Akif Ersoy University, Institute of Social Sciences, Department of Accounting and Financial Management, Master's Thesis

  BACKGROUND

• Gündüz, S., Yüksel, S., Aydeniz, G.E., Aydoğan, R.N., Türksoy, H., Dikme, İ.B., Efendiler, İ.(2016). Factors affecting the fear of hospitals in children. Journal of Child Health and Diseases, 59, (p:161-168).

  BACKGROUND

• Khazar, D. (2021). Examination of the process of creating linear algebra concepts in three-dimensional hologram-assisted learning. Dokuz Eylül University, Institute of Educational Sciences, Department of Primary Education, PhD Thesis.

  BACKGROUND

• Heden L, VON Essen L, Ljungman G. Randomized interventions for needle procedures in children with cancer. Eur J Cancer Care (Engl). 2009 Jul;18(4):358-63. doi: 10.1111/j.1365-2354.2008.00939.x. Epub 2008 Nov 27.

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• Heden L, von Essen L, Ljungman G. The relationship between fear and pain levels during needle procedures in children from the parents' perspective. Eur J Pain. 2016 Feb;20(2):223-30. doi: 10.1002/ejp.711. Epub 2015 Apr 2.

  PMID: 25845466 BACKGROUND

• Helvaci, A. (2019). The role of artistic activities in overcoming children's fears of hospitals. Kocaeli University Journal of Fine Arts Faculty; 5(6), (pp. 24-30).

  BACKGROUND

• Hologram technology? In which sector is it used? (2022, February 20). Access address:https://teknoloji.org/hologram-teknoloji-nedir-which-sektorlarda-kullaniyor/

  BACKGROUND

• Inal, S., Canbulat, N. (2015). Use of Attention-Diverting Methods in Transactional Pain Management in Children. Current Journal of Pediatrics, 13(2), (p:116-121). Access address:https://doi.org/10.4274/jcp.29292

  BACKGROUND

• İnci, R., Günay, U. (2019). Knowledge, Opinions and Applications of Pediatric Nurses for Therapeutic Play. Acıbadem University Journal of Health Sciences.10(3), (p:547-551. URL: https://doi.org/10.31067/0.2019.187

  BACKGROUND

• Kayıkçı, Ş.,Yürekli, A. (2020). The use of hologram technology in video mobile communication. European Journal of Science and Technology, (p:94-99) . DOI: 10.31590/ejosat.779097

  BACKGROUND

• Marashuna, O.(2011). Fears of medical procedures of secondary school students and influencing factors. Institute of Health Sciences, Near East University of the Turkish Republic of Northern Cyprus. Master's Thesis in Nursing. Cyprus.

  BACKGROUND

• Ozel A, Cetin H. [Effects of vibrating tourniquet application on the pain felt for blood drawing in pediatric patients]. Agri. 2020 Jan;32(1):25-30. doi: 10.14744/agri.2019.04900. Turkish.

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• Pancekauskaite G, Jankauskaite L. Paediatric Pain Medicine: Pain Differences, Recognition and Coping Acute Procedural Pain in Paediatric Emergency Room. Medicina (Kaunas). 2018 Nov 27;54(6):94. doi: 10.3390/medicina54060094.

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• Sarman A, Sarman S, Tuncay S. (2021). Quantitative and content review of graduate theses made using virtual reality in nursing and published in YÖK Thesis. BUSAD; 2(2), (pp. 71 - 82).

  BACKGROUND

• Semerci R, Kocaaslan EN, Akgun Kostak M, Akin N. [Reduction of pain during intravenous cannulation in children: Buzzy application]. Agri. 2020 Nov;32(4):177-185. doi: 10.14744/agri.2020.02223. Turkish.

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• Susam V, Friedel M, Basile P, Ferri P, Bonetti L. Efficacy of the Buzzy System for pain relief during venipuncture in children: a randomized controlled trial. Acta Biomed. 2018 Jul 18;89(6-S):6-16. doi: 10.23750/abm.v89i6-S.7378.

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• Sülü Uğurlu E.(2017). Nonpharmacological methods of pain relief in interventional procedures in children. Acıbadem University Journal of Health Sciences, 8(4),(p.198-201).

  BACKGROUND

• Trost MJ, Chrysilla G, Gold JI, Mataric M. Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children. Pain Res Manag. 2020 Apr 9;2020:7935215. doi: 10.1155/2020/7935215. eCollection 2020.

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• Ye W, Zhang X, Li T, Luo C, Yang L. Mixed-reality hologram for diagnosis and surgical planning of double outlet of the right ventricle: a pilot study. Clin Radiol. 2021 Mar;76(3):237.e1-237.e7. doi: 10.1016/j.crad.2020.10.017. Epub 2020 Dec 9.

  PMID: 33309030 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

• Ozturk C, Gunes U. Reducing procedural pain and fear in children using a hologram fan and bubble machine: A randomized controlled trial of passive distraction techniques. J Pediatr Nurs. 2025 Dec 16;86:559-567. doi: 10.1016/j.pedn.2025.12.004. Online ahead of print.

  PMID: 41406684 DERIVED

Related Links

• Wong-Baker Faces Pain Scale image, (2022, February 20)
• Hologram fan image, (2022, February 21st).
• How does holography work? ( 2022, February 10 ).

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ülkü Güneş

  Faculty of Nursing Lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The randomization method: Children who meet the sample selection criteria will be randomly assigned to three groups: bubble machine group (n=55), hologram fan group (n=55) and control group (n=55). The assignment of individuals to the study groups will be carried out by block randomization method and the blocks will be formed according to age groups (3-7 years / 8-12 years: 2 blocks). The confidentiality of assigning to groups will be ensured by a table of numbers created on the computer by a person independent of the research.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: September 21, 2023
• Study Start: May 13, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

TU (1)