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

September 28, 2022 updated by: University Hospital Tuebingen

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72070
        • University of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buzzy
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
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
Experimental: DistractionCards
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
In the DistrACTION® Cards group, picture cards containing various hidden pictures and patterns are used during blood collection by the PhD qualified nurse researcher
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Child's fear
Time Frame: Before and immediately after blood draw at 3-4 months

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
Time Frame: Before and immediately after blood draw at 3-4 months

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
Time Frame: Before and immediately after blood draw at 3-4 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's pain
Time Frame: immediately after blood draw at 3-4 months

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
Child's pain
Time Frame: immediately after blood draw at 3-4 months

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
Child's pain
Time Frame: immediately after blood draw at 3-4 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Birsen Bilgen Sivri, University of Tübingen Nursing Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Tübingen University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individual information of the participants (name, surname, address,..) will not be shared. A number will be given for each.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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