The Effect of Two Different Non-pharmacologic Methods for Painandfear Relief During Blood Specimen Collection Inchildren

NCT05560074 | Unknown

• 1 other identifier: Tübingen University
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Pain is defined as an unpleasant emotional and sensorial feeling that arises from any part of the body progresses with possible tissue damage and covers all past experiences of individuals. The aim of this randomized-controlled study is to compare the effect of two methods (Buzzy® and DistrACTION® Cards) used to reduce pain and anxiety during blood specimen collection in children. Material and Methods: Children between the ages of 6 and 12 who come to the Tübingen University Rheumatology outpatient clinic will be included in the study. Keywords: Pain, children, blood sample Research Hypotheses Hypothesis 0 (H0):There is no difference in terms of procedural pain and anxiety between children in the control group and interventions groups (Buzzy®, DistraCTION® Cards). Hypothesis 1 (H1): Children who received Buzzy® during venous blood specimen collection have less pain and anxiety than children in the control group. Hypothesis 2 (H2): Children who received DistrACTION® Cards during venous blood specimen collection have less pain and anxiety than children in the control group. Hypothesis 3 (H3): Children who received Buzzy® during venous blood specimen collection have less pain and anxiety than children in the DistrACTION® Cards group. In the study, we will use an information form that involves questions about the descriptive characteristics of the children and their families (parents' educational level, age, gender) and the blood specimen collection process (past and present experience), child's body mass index (BMI), the Children's Fear Scale (CFS) to determine the anxiety of the children and Faces Pain Scale-Revised (FPS-R) to evaluate pain. A pilot will be used to test whether the questions are understood before the questionnaires are administered. Keywords: Pain, children, blood sample, buzzy, distractionCards

Conditions

Pain

Keywords

Pain; children; buzzy; distractionCards; blood sample

Outcome Measures

Primary Outcomes (3)

• Change in the Child's fear

  Befor and immediately after blood draw will be assessed with Children's Fear Scale (CFS) (parent) The Children's Fear Scale (CFS) was adapted from the Faces Anxiety Scale to measure fear in children undergoing painful medical procedures. Fear facial expressions are seen from 0 to 4. These faces are showing different amounts of being scared. This face \[the left-most face\] is not scared at all, this face is a little bit more scared \[second face from left\], a bit more scared \[sweep finger along scale\], right up to the most scared possible \[the last face on the right\].

  Before and immediately after blood draw at 3-4 months

• Change in the Child's fear

  Befor and immediately after blood draw will be assessed with Children's Fear Scale (CFS) (child) The Children's Fear Scale (CFS) was adapted from the Faces Anxiety Scale to measure fear in children undergoing painful medical procedures. Fear facial expressions are seen from 0 to 4. These faces are showing different amounts of being scared. This face \[the left-most face\] is not scared at all, this face is a little bit more scared \[second face from left\], a bit more scared \[sweep finger along scale\], right up to the most scared possible \[the last face on the right\].

  Before and immediately after blood draw at 3-4 months

• Change in the Child's fear

  Befor and immediately after blood draw will be assessed with Children's Fear Scale (CFS) (researcher) The Children's Fear Scale (CFS) was adapted from the Faces Anxiety Scale to measure fear in children undergoing painful medical procedures. Fear facial expressions are seen from 0 to 4. These faces are showing different amounts of being scared. This face \[the left-most face\] is not scared at all, this face is a little bit more scared \[second face from left\], a bit more scared \[sweep finger along scale\], right up to the most scared possible \[the last face on the right\].

  Before and immediately after blood draw at 3-4 months

Secondary Outcomes (3)

• Child's pain

  immediately after blood draw at 3-4 months

• Child's pain

  immediately after blood draw at 3-4 months

• Child's pain

  immediately after blood draw at 3-4 months

Study Arms (3)

Buzzy

EXPERIMENTAL

Buzzy®: It is a 8x5x2.5 cm sized, noninvasive device used for pain control in adults and children, developed by the pediatrician Ammy Baxter, with a plastic battery and vibration motor. A cold ice pack is placed under Buzzy. It has a local cold application and vibration effect. It is placed 3\~5 cm above the injection site for 15\~30 sec before and during the procedure, making local cold application and vibrations. One should be sure about the definite contact of Buzzy® with the skin. The ice pack is kept in a deep freezer and placed in the device before the procedure. After the procedure is completed, the ice pack is wiped with 70% alcohol, and kept and chilled again in the deep freezer. http://www.buzzy4shots.com/)

Device: Buzzy

DistractionCards

EXPERIMENTAL

DistrACTION® Cards consisted of visual cards of 5 cm × 8 cm, covered with various pictures and shapes. In this method, the children first carefully examine the cards. Then, the PhD-qualified nurse researcher asks some questions about those cards to be answered by the children, such as "How many ladybugs are there in the picture?" "How many apes are there in the picture?" or "Can you see the comet?" The distraction procedure via distraction cards begin just before the venous blood specimen collection and continue until the end of the blood specimen collection

Other: DistrACTION® Cards

Control

NO INTERVENTION

Controll group: Venous blood will be taken as usual on the blood collection room without applying an intervention to the children in the Control group. Children will follow the standard blood draw procedure.

Interventions

Buzzy DEVICE

In the Buzzy® group, 30 seconds before the blood collection procedure and during the procedure, the Buzzy® device ist placed 3-5 cm above the area from where the blood would be taken by the PhD qualified nurse researcher

Buzzy

DistrACTION® Cards OTHER

In the DistrACTION® Cards group, picture cards containing various hidden pictures and patterns are used during blood collection by the PhD qualified nurse researcher

DistractionCards

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Children between the ages of 6-12 coming to the rheumatology outpatient clinic

You may not qualify if:

• having a disease that causes chronic pain,
• having a mental or neurologic disability,
• have received analgesics within the last 6 hours,
• history of fainting during blood collection,
• with cold urticaria

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tübingen

Tübingen, 72070, Germany

Location

Related Publications (7)

• 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 RESULT

• Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.

  PMID: 29559294 RESULT

• Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.

  PMID: 30829735 RESULT

• Walco GA. Needle pain in children: contextual factors. Pediatrics. 2008 Nov;122 Suppl 3:S125-9. doi: 10.1542/peds.2008-1055d.

  PMID: 18978005 RESULT

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 RESULT

• Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.

  PMID: 24809068 RESULT

• Bilgen Sivri B, Feng YS, Michler C, Kuemmerle-Deschner J, Mahler C. The effect of buzzy(R), DistrACTION(R) cards on reducing pediatric pain and fear during blood collection in the rheumatology polyclinic: A randomized controlled trial. J Pediatr Nurs. 2023 Nov-Dec;73:e446-e454. doi: 10.1016/j.pedn.2023.10.013. Epub 2023 Oct 31.

  PMID: 37919179 DERIVED

Related Links

• Buzzy
• International Association for the Study of Pain (IASP). Pain terminology.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Birsen Bilgen Sivri

  University of Tübingen Nursing Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 29, 2022
• Study Start: August 4, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)