PainNCT05560074
The Effect of Two Different Non-pharmacologic Methods for Painandfear Relief During Blood Specimen Collection Inchildren
A study testing Buzzy and DistrACTION® Cards in people with Pain, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Buzzy and DistrACTION® Cards
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- 4 Aug 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 6-12 coming to the rheumatology outpatient clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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:
- 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.
- 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
- Pain
- Being tested
- Buzzy, DistrACTION® Cards
- Keywords
- Pain, children, buzzy, distractionCards, blood sample
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyDevice
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® CardsOther
In the DistrACTION® Cards group, picture cards containing various hidden pictures and patterns are used during blood collection by the PhD qualified nurse researcher
| Study group | Role | What they receive |
|---|---|---|
| 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/) Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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].
Measured: 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].
Measured: Before and immediately after blood draw at 3-4 months
Secondary outcomes (3)
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].
Measured: immediately after blood draw at 3-4 months
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].
Measured: immediately after blood draw at 3-4 months
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].
Measured: immediately after blood draw at 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start4 Aug 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birsen Bilgen Sivri, Principal investigator, University of Tübingen Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560074
- Sponsor's protocol ID
- Tübingen University
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual information of the participants (name, surname, address,..) will not be shared. A number will be given for each.
Publications
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.
PubMed 31477677Gerceker 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.
PubMed 29559294Ballard 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.
PubMed 30829735Walco GA. Needle pain in children: contextual factors. Pediatrics. 2008 Nov;122 Suppl 3:S125-9. doi: 10.1542/peds.2008-1055d.
PubMed 18978005McMurtry 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.
PubMed 21806301Birnie 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.
PubMed 24809068Bilgen 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.
PubMed 37919179
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05560074
- Acronym / sponsor ID
- Tübingen University
- Conditions
- Pain
- Keywords
- Pain, children, buzzy, distractionCards, blood sample
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buzzy | Experimental | Device: BuzzyBuzzy®: 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/) |
| DistractionCards | Experimental | Other: DistrACTION® CardsDistrACTION® 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 |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 6-12 coming to the rheumatology outpatient clinic
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuzzyIn 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 | Device | Buzzy |
| DistrACTION® CardsIn the DistrACTION® Cards group, picture cards containing various hidden pictures and patterns are used during blood collection by the PhD qualified nurse researcher | Other | DistractionCards |
Primary outcome
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].
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].
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].
3 secondary outcomes
Child's pain
Time frame: immediately after blood draw at 3-4 months
Child's pain
Time frame: immediately after blood draw at 3-4 months
Child's pain
Time frame: immediately after blood draw at 3-4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Results publication: PubMed 31477677Sivri 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.
- Results publication: PubMed 29559294Gerceker 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.
- Results publication: PubMed 30829735Ballard 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.
- Results publication: PubMed 18978005Walco GA. Needle pain in children: contextual factors. Pediatrics. 2008 Nov;122 Suppl 3:S125-9. doi: 10.1542/peds.2008-1055d.
- Results publication: PubMed 21806301McMurtry 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.
- Results publication: PubMed 24809068Birnie 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.
- Derived from this study: PubMed 37919179Bilgen 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.
- BuzzyLink provided by the sponsor.
- International Association for the Study of Pain (IASP). Pain terminology.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The individual information of the participants (name, surname, address,..) will not be shared. A number will be given for each.
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Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birsen Bilgen Sivri principal investigator
University of Tübingen Nursing Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy and DistrACTION® Cards in people with Pain, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Child's fear (time frame: Before and immediately after blood draw at 3-4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560074, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.