The Effect of Two Different Non-pharmacologic Methods for Painandfear Relief During Blood Specimen Collection Inchildren
NCT ID: NCT05560074
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
99 participants
INTERVENTIONAL
2022-08-04
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tablet Distraction for Pain Control During Venipuncture
NCT02614391
Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
NCT03004456
Hypnoanalgesia for Dermatological Surgery in Children
NCT04707014
Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
NCT06373627
Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
NCT01394718
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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/)
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
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
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
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* having a mental or neurologic disability,
* have received analgesics within the last 6 hours,
* history of fainting during blood collection,
* with cold urticaria
6 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Birsen Bilgen Sivri
Role: PRINCIPAL_INVESTIGATOR
University of Tübingen Nursing Science
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Tübingen
Tübingen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Walco GA. Needle pain in children: contextual factors. Pediatrics. 2008 Nov;122 Suppl 3:S125-9. doi: 10.1542/peds.2008-1055d.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
International Association for the Study of Pain (IASP). Pain terminology.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Tübingen University
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.