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

Pain Clinical Trial

Official title:

The Effect of Two Different Non-pharmacologic Methods (Buzzy® and DistrACTION® Cards) for Pain and Fear Relief During Blood Specimen Collection in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05560074
• Other study ID #: Tübingen University
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The study will be carried out with the children and their parents who come to the rheumatology outpatient clinic at the University Hospital Tuebingen with their parents and met the sampling selection criteria.

An information letter describing the research study will be sent to the addresses of children and their families who meet the criteria before they come to the outpatient department.

When the child and parent come to the outpatient appointment:

• The study will begin after a doctor's examination, whose blood is decided to be drawn. Blood collection will be done in a separate room.

• The researcher will explain the study herself to the child (6-12 years old) and parents. First of all, the parents and children will be informed about the research via the "Information and Consent Form" (Appendix-2,3,4,5) and will be included in the study if they wish to participate. All participants will be informed about the possibility to withdraw their participation. Only participants who have received written and verbal consent to participate in the study will be included.

• According to the computer program (from 1 to 99), blood collection from the children will be done by the researcher herself, according to the order determined by the randomization.

Course of the study control and intervention group and examination methods:

1. All groups:

Before the venous blood collection: The parents and their children are informed about the procedures and their written and verbal consent are received. Randomization is performed. Socio-demographic information form is filled in. The children, parents, and researcher are asked to evaluate the child's level of fear using the CFS.

2. Intervention and Control:

During the venous blood collection: The blood collection procedure of all children participating in the study is performed by a PhD qualified nurse researcher experienced in blood collection using a 21-G vacuum blood collection tube needle tip from the arm. To avoid bias which can affect pain sensation or fear of the child a standardized procedure is performed during the study so that environmental bias can be excluded. The blood of the children in all groups will be taken by the same PhD qualified nurse researcher herself in the blood collection room. She will approach the children and parents in the same way and take care that the childrens perception of pain and fear is not affected by external factors.

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.

Intervention group 1: In the DistrACTION® Cards group, picture cards containing various hidden pictures and patterns are used during blood collection by the PhD qualified nurse researcher.

Intervention group 2: 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

Data Collection Tools:

• Information form containing socio-demographics and further characteristics of the child and his family and questions on previous and current experience of the blood drawing process

• Child's pain " Faces Pain Scale-Revised (FPS-R)"

• Child's fear "Children's Fear Scale" and

• "Application Registration Form" to save the measurements made after the procedure Information form; It consists of six open and closed-ended questions about the introductory characteristics of the child and his family (parents' education level, age, gender), the blood specimen collection process (past experience), and the blood child's body mass index (BMI). In this study, the form will be filled before the blood specimen collection.

Faces Pain Scale-Revised (FPS-R) consists of six facial expressions rated from 0 to 10 according to the presence and level of pain. This scale is based on a valid and reliable personal expression in children during painful situations. In school-aged children (aged 4~12 years), the FPS-R is felt to be the most valid and reliable measure of acute pain because an understanding of words or numeric values is not needed. In the study, FPS-R are used to evaluate the children's pain after the procedure (by the children, parents, 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]. In the study, CFS are used to evaluate the children's fear before and after the procedure (by the children, parents, researcher).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Buzzy
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

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

Locations

Country	Name	City	State
Germany	University of Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

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. Epub 2014 May 7. — View Citation

Gerçeker GÖ, 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: 10.10 — View Citation

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. — View Citation

Sivri Bilgen B, Balci S. The Effect on Pain of Buzzy® and ShotBlocker® 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Child's pain	After blood draw will be assessed with Faces Pain Scale-Revised (FPS-R) (parent); Faces Pain Scale-Revised (FPS-R) consists of six facial expressions rated from 0 to 10 according to the presence and level of pain.This face [the left-most face] is not pain at all, right up to the most pain possible [the last face on the right].	immediately after blood draw at 3-4 months
Secondary	Child's pain	After blood draw will be assessed with Faces Pain Scale-Revised (FPS-R) (child); Faces Pain Scale-Revised (FPS-R) consists of six facial expressions rated from 0 to 10 according to the presence and level of pain.This face [the left-most face] is not pain at all, right up to the most pain possible [the last face on the right].	immediately after blood draw at 3-4 months
Secondary	Child's pain	After blood draw will be assessed with Faces Pain Scale-Revised (FPS-R)(researcher); Faces Pain Scale-Revised (FPS-R) consists of six facial expressions rated from 0 to 10 according to the presence and level of pain.This face [the left-most face] is not pain at all, right up to the most pain possible [the last face on the right].	immediately after blood draw at 3-4 months

External Links

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