Procedural PainNCT06044701
Pain and Fear During Intravenous Blood Collection in Children
A study testing Hologram Distraction Technique and Bubble Machine Distraction Technique in people with Procedural Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Medical procedures can cause significant stress and anxiety for children and parents, impacting their overall hospital experience. Numerous studies have demonstrated that techniques aimed at diverting attention during procedures can effectively reduce pain and fear. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Hologram Distraction Technique and Bubble Machine Distraction Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2022to 20 Apr 2023
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient who needs to take intravenous blood
- The participant is in the 3-12 age group
Who cannot join
- Failure to obtain consent
- The child has an intellectual or neurological disability
- Failure to communicate in Turkish
- Having visual and hearing impairment
- The child has complaints such as pain, nausea, vomiting, etc. that disrupt his comfort due to another reason.
- 6 hours before the use of analgesic or sedative drugs
Show all 9Show fewer
- Lack of healthy skin integrity
- Having repeated attempts
- Having syncope during blood collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hologram Fan and Bubble Machine Use on Pain and Fear During Intravenous Blood Collection in Children
Medical procedures can cause significant stress and anxiety for children and parents, impacting their overall hospital experience. Numerous studies have demonstrated that techniques aimed at diverting attention during procedures can effectively reduce pain and fear. Considering the rapid advancements in technology and the strong connection between Generation Z children and technology, this study aims to explore the use of hologram technology through a hologram fan and the traditional method of bubble blowing as interventions to assess their impact on pain and fear levels during intravenous blood collection in children.
The study design will follow a randomized controlled trial approach. The sample will consist of patients between the ages of 3 and 12 who meet the sampling criteria and receive outpatient care at the pediatric stem cell outpatient treatment unit between April 2022 and February 2024. Data will be collected using a researcher-prepared form containing introductory information and child pain, fear, and emotional indicator scales for which appropriate permissions have been obtained. The blood collection process will be performed by the unit's nurse, and the observer nurse will complete the scales.
Read more
Descriptive statistics, such as mean, standard deviation (median, minimum, maximum), frequency, and percentage values, will be used for data analysis. IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) will be employed for data analysis. A significance level of 0.05 will be used for all statistical analyses.
Regenerate response Keywords: Fear, pain, pediatrics, hologram, bubble-blowing, invasive procedures
Read the detailed description
Pediatric clinics often subject infants and children to painful medical procedures. These interventions include blood collection, intramuscular and intravenous injections, which can induce pain and fear in children. The experience of pain during medical procedures has long-term effects and can shape a person's approach to healthcare in the future. While evidence-based practices exist to address interventional pain in the pediatric population, they may not always be sufficient in practice. As technology advances, there is growing interest in innovative methods to reduce pain, alongside commercially available products.
Distraction techniques have been proven effective in reducing acute pain in children during needle interventions. Distraction aims to redirect the child's attention to another stimulus, based on the understanding that the brain has limited capacity to focus on pain. Nurses and healthcare workers play a crucial role in alleviating children's fear of medical procedures, as they are often the first point of contact and provide ongoing care.
In addition to traditional methods such as watching cartoons, inflating balloons, and playing music, innovative techniques have emerged. One such method is the use of bubble machines, which produce bubbles using blowing and spraying systems. Studies have shown that bubble blowing can effectively reduce pain intensity during phlebotomy in children aged 3-6 years. Other studies have recommended using bubble blowing alongside devices like Buzzy to reduce pain severity during phlebotomy and intramuscular injections.
Considering the current pandemic situation, the use of bubble machines has gained attention as a potentially more effective distraction method than balloon blowing, as it reduces the risk of infection and provides a greater number of bubbles in the environment. Moreover, hologram technology has gained popularity in our daily lives. Holography refers to three-dimensional projections that can be seen without special equipment. It has the potential to revolutionize medicine by providing realistic and immersive experiences. However, there is a lack of studies exploring the application of hologram technology in reducing pain during medical procedures, particularly in the nursing literature. It is believed that this technology can effectively distract children during painful interventions.
Technological advancements, including hologram technology, have the potential to significantly impact the healthcare sector. By utilizing such applications, especially for diversion and comfort in pediatric pain management, healthcare professionals can improve the overall experience of children. The use of technology can also enhance efficiency and service quality in healthcare, benefiting patients of all age groups.
In this context, the present study aims to investigate the use of hologram fans and bubble machines to divert attention, reduce fear and pain levels, and improve compliance during intravenous blood collection in children. This unique study, which incorporates hologram technology, aims to contribute to the existing literature. Similar to bubble machines, bubble blowing toys have been studied and have shown attention-grabbing effects. Therefore, this study is necessary to explore the effects of hologram fans and bubble machines on children's pain and fear levels during intravenous blood collection, a highly stressful procedure for both children and parents, and to introduce new methods to the literature on this topic.
Hologram: The word hologram means "three-dimensional image recording system" in Turkish. Hologram is the name given to the picture obtained by the use of coherent laser beams. Along with the intensity of light, the hologram allows an object to be seen in three dimensions by recording the direction of the light waves.
Hologram Fan: A hologram fan is one of the industrial electronic products that creates an illusion of 3D objects circling in the air. The fan rotates too fast to be seen with the naked eye, resulting in a transparent background for the projected object.
Bubble Machine: These are the systems used in blowing sequencing by adding liquid mixtures specially prepared for bubbles to the machine chamber. Warm-up times are provided in 5-10 seconds, the machines provide use on blowing and spraying systems and the production of bubbles and their release to the space used.
Purpose of the Study: The aim of this study was to investigate the effect of hologram fan and bubble machine use on pain and fear levels during blood collection process in children who applied to Pediatric Stem Cell Transplantation Polyclinic at Ege University Children's Hospital.
Hypotheses H1: The use of a hologram fan reduces interventional pain during the blood collection process.
H2: The use of a bubble machine reduces interventional pain during the blood collection process.
H3: The use of a hologram fan reduces the fear of interference during the blood collection process.
H4: The use of a bubble machine reduces the fear of interference during the blood collection process.
H5: The use of a hologram fan affects the emotional behavior scale score during the blood collection process.
H6: The use of a bubble machine affects the emotional behavior scale score during the blood collection process.
Wong- Baker Faces Pain Scale The scale consists of six black and white faces, ranging from a smiling face to a painful face. The child is told about the pain level of the faces on the scale and told to choose the face that best expresses his or her pain.
Child Fear Scale It was adapted from the Faces Anxiety Scale by McMurty and colleagues to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a scale rated 0-4 that shows five hundred ranging from a neutral expression (0 = no worry) to a feared face (4 = serious anxiety).
Emotional Indicators Scale in Children: It is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators that children show against medical procedures.
Collection of Data Two research-independent volunteer nurses with at least 10 years of experience will assist in the data collection process. The observer nurse will be informed by the researcher about the scale forms to be used in the study process. The polyclinic nurse will perform the routine nursing intervention. Nurses do not have conflicts of interest with research.
First of all, the participants who are waiting to have blood drawn at the entrance of the polyclinic by the researcher and who meet the sample selection criteria will be informed about the research and informed consent will be obtained from the child and parent. The data will then be recorded by asking questions about the characteristics of the participant and his/her parents included in the data collection form and the processing. Children who meet the criteria will be assigned to the application groups according to the randomization list created by the researcher.
Data evaluation/statistical methods of the study Descriptive statistics of the data; mean, standard deviation (median, minimum, maximum) will be given as frequency and percentage values. The assumption of normality of the quantitative data will be checked by the Shapiro-Wilk test. Unidirectional ANOVA (Bonferroni or Tukey test for binary comparisons) will be used for variables with normal distributions, while Kruskal-Wallis test (Dunn test for binary comparisons) will be used for variables that do not provide normality assumption. The correlation of quantitative data with each other will be evaluated by Pearson or Spearman's Rho correlation coefficients. The relationships between categorical variables will be examined by the Pearson Chi-square test or Fisher's Full probability test.
The data were analyzed using SPSS (22.0) software. The significance level was determined as 0.05 in all analyzes.
- Conditions
- Procedural Pain
- Being tested
- Hologram Distraction Technique, Bubble Machine Distraction Technique
- Keywords
- fear, pain, pediatrics, hologram, bubble-blowing, invasive procedures
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hologram Distraction TechniqueOther
Also called Hologram Fan
Hologram fan application during blood collection process
Bubble Machine Distraction TechniqueOther
Also called Bubble machine
Bubble machine application during blood collection
| Study group | Role | What they receive |
|---|---|---|
| Hologram fan | Active comparator | Hologram fan application during blood collection process Receives: Other: Hologram Distraction Technique |
| Bubble machine | Active comparator | Bubble machine application during blood collection Receives: Other: Bubble Machine Distraction Technique |
| Control Group | No intervention | Performing routine application during the blood collection process |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Child Fear Scale
Child Fear Scale (CSS) was used. This scale is a single-item self-report measure used to measure pain-related fear in children. This single-item scale consists of five gender-neutral facets. It ranges from a fearless (neutral) face on the far left to a face showing extreme fear on the far right. The evaluator's response indicates the level of fear. It can be used by parents and researchers before and during the procedure in children aged 5-10 years. CFS was applied to the children by the researcher to evaluate their fear levels regarding blood collection before, during and after the blood collection procedure.
Measured: an average of 6 months
Wong Baker Pain Scale
Wong-Baker FACES (WB-FACES) Pain Rating Scale was used. This scale is used to rate pain intensity in children ages 3 and older. This numerical rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = very painful). This scale was evaluated by the researcher during and after blood collection in this study.
Measured: an average of 6 months
Emotional Indicators Scale
The Emotional Indicators Scale is used to assess the child's emotional reactions immediately after the needle enters the skin during blood collection. The scale measures emotional indicators such as crying, facial expressions, and distress, with ratings ranging from 0-5 (with 0 indicating no emotional response and 5 representing a strong emotional response). Higher scores on the scale may indicate a worse outcome in terms of emotional distress.This scale was evaluated by the researcher during blood collection in this study.
Measured: an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start13 May 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The randomization method: Children who meet the sample selection criteria will be randomly assigned to three groups: bubble machine group (n=55), hologram fan group (n=55) and control group (n=55). The assignment of individuals to the study groups will be carried out by block randomization method and the blocks will be formed according to age groups (3-7 years / 8-12 years: 2 blocks). The confidentiality of assigning to groups will be ensured by a table of numbers created on the computer by a person independent of the research.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANSU OZTURK, Ege University
- Investigators
- Ülkü Güneş, Study director, Faculty of Nursing Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044701
- Sponsor's protocol ID
- EU-SBE-CO-01
- Status last verified
- Sep 2023
- First submitted
- 5 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.
PubMed 30711327Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
PubMed 29237632Ballard A, Khadra C, Adler S, Doyon-Trottier E, Le May S. Efficacy of the Buzzy(R) device for pain management of children during needle-related procedures: a systematic review protocol. Syst Rev. 2018 May 22;7(1):78. doi: 10.1186/s13643-018-0738-1.
PubMed 29788987Binay S, Bilsin E, Gerceker GO, Kahraman A, Bal-Yilmaz H. Comparison of the Effectiveness of Two Different Methods of Decreasing Pain During Phlebotomy in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2019 Aug;34(4):749-756. doi: 10.1016/j.jopan.2018.11.010. Epub 2019 Feb 20.
PubMed 30797673Burunsuz E.G, Köse S. (2020). The effect of butterfly patterned detection material used in intravenous catheter application on emotional and physiological indicators of children. Online Turkish Journal of Health Sciences, 5(4), (p:673-682).
Çalış, H., Karataş, P. (2019). Atraumatic care approach in pediatric nursing: non-pharmacological applications in reducing pain, stress and anxiety. Koç University Journal of Education and Research in Nursing, 16 (3): (p:234-245). DOI:10.5222/HEAD.2019.234
Çantaş Ayar, A. (2018). White noise during the process of taking blood from the heel of the foot in newborns, the effect of the position of the fetus in the lap and the fetal position given by hand on pain. Master's Thesis. Trabzon.
Dalley JS, McMurtry CM. Teddy and I Get a Check-Up: A Pilot Educational Intervention Teaching Children Coping Strategies for Managing Procedure-Related Pain and Fear. Pain Res Manag. 2016;2016:4383967. doi: 10.1155/2016/4383967. Epub 2016 Apr 7.
PubMed 27445612Dincer, A. (2017). Fear: Language, Conceptualization, Cultural Dimension. International Journal of Turkish Literature Culture and Education, 6(2), (p:769-798).
Dumandag, F. (2019). Evaluation of the effect of pre-procedure education on the compliance and anxiety level of the upper gastrointestinal tract endoscopy. Biruni University Institute of Health Sciences Department of Nursing Master's Program. Istanbul.
Engin, M. (2020). A study to determine student opinions on the use of hologram technology in accounting education. Burdur Mehmet Akif Ersoy University, Institute of Social Sciences, Department of Accounting and Financial Management, Master's Thesis
Gündüz, S., Yüksel, S., Aydeniz, G.E., Aydoğan, R.N., Türksoy, H., Dikme, İ.B., Efendiler, İ.(2016). Factors affecting the fear of hospitals in children. Journal of Child Health and Diseases, 59, (p:161-168).
Khazar, D. (2021). Examination of the process of creating linear algebra concepts in three-dimensional hologram-assisted learning. Dokuz Eylül University, Institute of Educational Sciences, Department of Primary Education, PhD Thesis.
Heden L, VON Essen L, Ljungman G. Randomized interventions for needle procedures in children with cancer. Eur J Cancer Care (Engl). 2009 Jul;18(4):358-63. doi: 10.1111/j.1365-2354.2008.00939.x. Epub 2008 Nov 27.
PubMed 19040458Heden L, von Essen L, Ljungman G. The relationship between fear and pain levels during needle procedures in children from the parents' perspective. Eur J Pain. 2016 Feb;20(2):223-30. doi: 10.1002/ejp.711. Epub 2015 Apr 2.
PubMed 25845466
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hologram Fan and Bubble Machine Use on Pain and Fear During Intravenous Blood Collection in Children
- ClinicalTrials.gov ID
- NCT06044701
- Acronym / sponsor ID
- EU-SBE-CO-01
- Conditions
- Procedural Pain
- Keywords
- fear, pain, pediatrics, hologram, bubble-blowing, invasive procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 21 Sep 2023 (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.
Medical procedures can cause significant stress and anxiety for children and parents, impacting their overall hospital experience. Numerous studies have demonstrated that techniques aimed at diverting attention during procedures can effectively reduce pain and fear. Considering the rapid advancements in technology and the strong connection between Generation Z children and technology, this study aims to explore the use of hologram technology through a hologram fan and the traditional method of bubble blowing as interventions to assess their impact on pain and fear levels during intravenous blood collection in children.
The study design will follow a randomized controlled trial approach. The sample will consist of patients between the ages of 3 and 12 who meet the sampling criteria and receive outpatient care at the pediatric stem cell outpatient treatment unit between April 2022 and February 2024. Data will be collected using a researcher-prepared form containing introductory information and child pain, fear, and emotional indicator scales for which appropriate permissions have been obtained. The blood collection process will be performed by the unit's nurse, and the observer nurse will complete the scales.
Descriptive statistics, such as mean, standard deviation (median, minimum, maximum), frequency, and percentage values, will be used for data analysis. IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) will be employed for data analysis. A significance level of 0.05 will be used for all statistical analyses.
Regenerate response Keywords: Fear, pain, pediatrics, hologram, bubble-blowing, invasive procedures
Detailed description
Pediatric clinics often subject infants and children to painful medical procedures. These interventions include blood collection, intramuscular and intravenous injections, which can induce pain and fear in children. The experience of pain during medical procedures has long-term effects and can shape a person's approach to healthcare in the future. While evidence-based practices exist to address interventional pain in the pediatric population, they may not always be sufficient in practice. As technology advances, there is growing interest in innovative methods to reduce pain, alongside commercially available products.
Distraction techniques have been proven effective in reducing acute pain in children during needle interventions. Distraction aims to redirect the child's attention to another stimulus, based on the understanding that the brain has limited capacity to focus on pain. Nurses and healthcare workers play a crucial role in alleviating children's fear of medical procedures, as they are often the first point of contact and provide ongoing care.
In addition to traditional methods such as watching cartoons, inflating balloons, and playing music, innovative techniques have emerged. One such method is the use of bubble machines, which produce bubbles using blowing and spraying systems. Studies have shown that bubble blowing can effectively reduce pain intensity during phlebotomy in children aged 3-6 years. Other studies have recommended using bubble blowing alongside devices like Buzzy to reduce pain severity during phlebotomy and intramuscular injections.
Considering the current pandemic situation, the use of bubble machines has gained attention as a potentially more effective distraction method than balloon blowing, as it reduces the risk of infection and provides a greater number of bubbles in the environment. Moreover, hologram technology has gained popularity in our daily lives. Holography refers to three-dimensional projections that can be seen without special equipment. It has the potential to revolutionize medicine by providing realistic and immersive experiences. However, there is a lack of studies exploring the application of hologram technology in reducing pain during medical procedures, particularly in the nursing literature. It is believed that this technology can effectively distract children during painful interventions.
Technological advancements, including hologram technology, have the potential to significantly impact the healthcare sector. By utilizing such applications, especially for diversion and comfort in pediatric pain management, healthcare professionals can improve the overall experience of children. The use of technology can also enhance efficiency and service quality in healthcare, benefiting patients of all age groups.
In this context, the present study aims to investigate the use of hologram fans and bubble machines to divert attention, reduce fear and pain levels, and improve compliance during intravenous blood collection in children. This unique study, which incorporates hologram technology, aims to contribute to the existing literature. Similar to bubble machines, bubble blowing toys have been studied and have shown attention-grabbing effects. Therefore, this study is necessary to explore the effects of hologram fans and bubble machines on children's pain and fear levels during intravenous blood collection, a highly stressful procedure for both children and parents, and to introduce new methods to the literature on this topic.
Hologram: The word hologram means "three-dimensional image recording system" in Turkish. Hologram is the name given to the picture obtained by the use of coherent laser beams. Along with the intensity of light, the hologram allows an object to be seen in three dimensions by recording the direction of the light waves.
Hologram Fan: A hologram fan is one of the industrial electronic products that creates an illusion of 3D objects circling in the air. The fan rotates too fast to be seen with the naked eye, resulting in a transparent background for the projected object.
Bubble Machine: These are the systems used in blowing sequencing by adding liquid mixtures specially prepared for bubbles to the machine chamber. Warm-up times are provided in 5-10 seconds, the machines provide use on blowing and spraying systems and the production of bubbles and their release to the space used.
Purpose of the Study: The aim of this study was to investigate the effect of hologram fan and bubble machine use on pain and fear levels during blood collection process in children who applied to Pediatric Stem Cell Transplantation Polyclinic at Ege University Children's Hospital.
Hypotheses H1: The use of a hologram fan reduces interventional pain during the blood collection process.
H2: The use of a bubble machine reduces interventional pain during the blood collection process.
H3: The use of a hologram fan reduces the fear of interference during the blood collection process.
H4: The use of a bubble machine reduces the fear of interference during the blood collection process.
H5: The use of a hologram fan affects the emotional behavior scale score during the blood collection process.
H6: The use of a bubble machine affects the emotional behavior scale score during the blood collection process.
Wong- Baker Faces Pain Scale The scale consists of six black and white faces, ranging from a smiling face to a painful face. The child is told about the pain level of the faces on the scale and told to choose the face that best expresses his or her pain.
Child Fear Scale It was adapted from the Faces Anxiety Scale by McMurty and colleagues to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a scale rated 0-4 that shows five hundred ranging from a neutral expression (0 = no worry) to a feared face (4 = serious anxiety).
Emotional Indicators Scale in Children: It is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators that children show against medical procedures.
Collection of Data Two research-independent volunteer nurses with at least 10 years of experience will assist in the data collection process. The observer nurse will be informed by the researcher about the scale forms to be used in the study process. The polyclinic nurse will perform the routine nursing intervention. Nurses do not have conflicts of interest with research.
First of all, the participants who are waiting to have blood drawn at the entrance of the polyclinic by the researcher and who meet the sample selection criteria will be informed about the research and informed consent will be obtained from the child and parent. The data will then be recorded by asking questions about the characteristics of the participant and his/her parents included in the data collection form and the processing. Children who meet the criteria will be assigned to the application groups according to the randomization list created by the researcher.
Data evaluation/statistical methods of the study Descriptive statistics of the data; mean, standard deviation (median, minimum, maximum) will be given as frequency and percentage values. The assumption of normality of the quantitative data will be checked by the Shapiro-Wilk test. Unidirectional ANOVA (Bonferroni or Tukey test for binary comparisons) will be used for variables with normal distributions, while Kruskal-Wallis test (Dunn test for binary comparisons) will be used for variables that do not provide normality assumption. The correlation of quantitative data with each other will be evaluated by Pearson or Spearman's Rho correlation coefficients. The relationships between categorical variables will be examined by the Pearson Chi-square test or Fisher's Full probability test.
The data were analyzed using SPSS (22.0) software. The significance level was determined as 0.05 in all analyzes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The randomization method: Children who meet the sample selection criteria will be randomly assigned to three groups: bubble machine group (n=55), hologram fan group (n=55) and control group (n=55). The assignment of individuals to the study groups will be carried out by block randomization method and the blocks will be formed according to age groups (3-7 years / 8-12 years: 2 blocks). The confidentiality of assigning to groups will be ensured by a table of numbers created on the computer by a person independent of the research.
| Arm | Type | Receives |
|---|---|---|
| Hologram fan | Active comparator | Other: Hologram Distraction TechniqueHologram fan application during blood collection process |
| Bubble machine | Active comparator | Other: Bubble Machine Distraction TechniqueBubble machine application during blood collection |
| Control Group | No intervention | –Performing routine application during the blood collection process |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient who needs to take intravenous blood
- The participant is in the 3-12 age group
Key exclusion criteria (9 listed)
- Failure to obtain consent
- The child has an intellectual or neurological disability
- Failure to communicate in Turkish
- Having visual and hearing impairment
- The child has complaints such as pain, nausea, vomiting, etc. that disrupt his comfort due to another reason.
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 |
|---|---|---|
| Hologram Distraction TechniqueAlso: Hologram FanHologram fan application during blood collection process | Other | Hologram fan |
| Bubble Machine Distraction TechniqueAlso: Bubble machineBubble machine application during blood collection | Other | Bubble machine |
Primary outcome
The Child Fear Scale
Time frame: an average of 6 months
Child Fear Scale (CSS) was used. This scale is a single-item self-report measure used to measure pain-related fear in children. This single-item scale consists of five gender-neutral facets. It ranges from a fearless (neutral) face on the far left to a face showing extreme fear on the far right. The evaluator's response indicates the level of fear. It can be used by parents and researchers before and during the procedure in children aged 5-10 years. CFS was applied to the children by the researcher to evaluate their fear levels regarding blood collection before, during and after the blood collection procedure.
Wong Baker Pain Scale
Time frame: an average of 6 months
Wong-Baker FACES (WB-FACES) Pain Rating Scale was used. This scale is used to rate pain intensity in children ages 3 and older. This numerical rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/no pain) to crying (10 = very painful). This scale was evaluated by the researcher during and after blood collection in this study.
Emotional Indicators Scale
Time frame: an average of 6 months
The Emotional Indicators Scale is used to assess the child's emotional reactions immediately after the needle enters the skin during blood collection. The scale measures emotional indicators such as crying, facial expressions, and distress, with ratings ranging from 0-5 (with 0 indicating no emotional response and 5 representing a strong emotional response). Higher scores on the scale may indicate a worse outcome in terms of emotional distress.This scale was evaluated by the researcher during blood collection in this study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 30711327Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.
- Background: PubMed 29237632Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
- Background: PubMed 29788987Ballard A, Khadra C, Adler S, Doyon-Trottier E, Le May S. Efficacy of the Buzzy(R) device for pain management of children during needle-related procedures: a systematic review protocol. Syst Rev. 2018 May 22;7(1):78. doi: 10.1186/s13643-018-0738-1.
- Background: PubMed 30797673Binay S, Bilsin E, Gerceker GO, Kahraman A, Bal-Yilmaz H. Comparison of the Effectiveness of Two Different Methods of Decreasing Pain During Phlebotomy in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2019 Aug;34(4):749-756. doi: 10.1016/j.jopan.2018.11.010. Epub 2019 Feb 20.
- BackgroundBurunsuz E.G, Köse S. (2020). The effect of butterfly patterned detection material used in intravenous catheter application on emotional and physiological indicators of children. Online Turkish Journal of Health Sciences, 5(4), (p:673-682).
- BackgroundÇalış, H., Karataş, P. (2019). Atraumatic care approach in pediatric nursing: non-pharmacological applications in reducing pain, stress and anxiety. Koç University Journal of Education and Research in Nursing, 16 (3): (p:234-245). DOI:10.5222/HEAD.2019.234
- BackgroundÇantaş Ayar, A. (2018). White noise during the process of taking blood from the heel of the foot in newborns, the effect of the position of the fetus in the lap and the fetal position given by hand on pain. Master's Thesis. Trabzon.
- Background: PubMed 27445612Dalley JS, McMurtry CM. Teddy and I Get a Check-Up: A Pilot Educational Intervention Teaching Children Coping Strategies for Managing Procedure-Related Pain and Fear. Pain Res Manag. 2016;2016:4383967. doi: 10.1155/2016/4383967. Epub 2016 Apr 7.
- BackgroundDincer, A. (2017). Fear: Language, Conceptualization, Cultural Dimension. International Journal of Turkish Literature Culture and Education, 6(2), (p:769-798).
- BackgroundDumandag, F. (2019). Evaluation of the effect of pre-procedure education on the compliance and anxiety level of the upper gastrointestinal tract endoscopy. Biruni University Institute of Health Sciences Department of Nursing Master's Program. Istanbul.
- BackgroundEngin, M. (2020). A study to determine student opinions on the use of hologram technology in accounting education. Burdur Mehmet Akif Ersoy University, Institute of Social Sciences, Department of Accounting and Financial Management, Master's Thesis
- BackgroundGündüz, S., Yüksel, S., Aydeniz, G.E., Aydoğan, R.N., Türksoy, H., Dikme, İ.B., Efendiler, İ.(2016). Factors affecting the fear of hospitals in children. Journal of Child Health and Diseases, 59, (p:161-168).
- Wong-Baker Faces Pain Scale image, (2022, February 20)Link provided by the sponsor.
- Hologram fan image, (2022, February 21st).Link provided by the sponsor.
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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.
Ülkü Güneş study director
Faculty of Nursing Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hologram Distraction Technique and Bubble Machine Distraction Technique in people with Procedural Pain, run by Ege University at 1 site in Turkey (Türkiye).
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Child Fear Scale (time frame: an average of 6 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 NCT06044701, which also lists 31 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 21 Sep 2023.