Clinical trial NCT05560074: The Effect of Two Different Non-pharmacologic Methods for Painandfear Relief During Blood Specimen Collection Inchildren
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain
children
buzzy
distractionCards
blood sample
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Child's fear
timeFrame: Before and immediately after blood draw at 3-4 months
measure: Change in the Child's fear
timeFrame: Before and immediately after blood draw at 3-4 months
measure: Change in the Child's fear
timeFrame: Before and immediately after blood draw at 3-4 months
Secondary outcomes:
measure: Child's pain
timeFrame: immediately after blood draw at 3-4 months
measure: Child's pain
timeFrame: immediately after blood draw at 3-4 months
measure: Child's pain
timeFrame: immediately after blood draw at 3-4 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
Study officials:
affiliation: University of Tübingen Nursing Science
name: Birsen Bilgen Sivri
role: PRINCIPAL_INVESTIGATOR
References:
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