Intravenous CatheterizationNCT05747833
The Effect of Toy IV Catheter on Children's Pain, Fear and Emotional Indicators
A study testing Children Preparation With a Toy IV Catheter Before Peripheral Cannula application in people with Intravenous Catheterization, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Research was conducted to determine the effect of preparation for the procedure with a toy IV catheter before IV catheterization in children aged 6-10 years, on children's pain, fear and emotional indicators. Methods: It is a randomized controlled intervention study. The study was completed with 80 children. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Catheterization
- What is being tested?
- Children Preparation With a Toy IV Catheter Before Peripheral Cannula application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2020to 30 Dec 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Your child;
- Age between 6-10,
- To receive IV treatment upon the request of a physician,
- Being conscious and able to communicate verbally,
- Understanding and speaking Turkish,
- Having a mother and / or father with him,
Show all 9Show fewer
- After the information, the child and his parents agree to participate in the study in writing and verbally,
- Pediatric Emergency Clinic has been accepted to the Green Area,
- Not using analgesic and / or sedative drugs in the last 8 hours.
Who cannot join
- Your child;
- Being younger than 6 and over 10 years old,
- Having pain,
- Having a high fever (body temperature of 38 ° C and above) Applying to the hospital with a complaint that requires urgent intervention such as convulsion or trauma,
- Having applied to the hospital by ambulance,
- Admitted to the Yellow or Red Area of the Pediatric Emergency Clinic after triage,
Show all 10Show fewer
- Having had an IV catheter before,
- Having mental disability,
- Having a chronic and / or fatal disease, Having a diagnosis made by psychiatry,
- Communication problems with his family and / or himself (not speaking Turkish, agitation, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: The Effect of Preparation for Procedure With Toy IV Catheter Before Peripheral Cannula Administration on Children's Pain, Fear, and Emotional Indicators
Aim: Research was conducted to determine the effect of preparation for the procedure with a toy IV catheter before IV catheterization in children aged 6-10 years, on children's pain, fear and emotional indicators.
Methods: It is a randomized controlled intervention study. The study was completed with 80 children. There are two groups in the study. Before the IV catheterization, the children in the intervention group were treated with the toy IV catheter developed by the researchers on the knitted doll, and then the procedure was provided to them. Conversely, no intervention was applied to the control group other than the normal procedure of the hospital. Stratified block randomization method was used to assign children to groups. In the study; "Personal Data Collection Form", "Wong-Baker Faces Pain Scale (WBFPS)", "Child Fear Scale (CFS)" and "Child Emotional Manifestation Scale (CEMS)" were used to collect data.
Read the detailed description
Children may be sick during their normal development and may have to come to the hospital. For children, the hospital environment, especially emergency rooms, conveys uncertainty. The reason for this uncertainty; the presence of health team members that children do not know, equipment they have not seen before, and interventions. The child's sense of uncertainty and the thought that his own control is in danger may cause him to become stressed and afraid of the hospital. As a matter of fact, studies on children's hospital experience indicate that they experience negative emotions such as stress, anger, restlessness, and tension. It is known that the most common negative emotion and experience children experience in the hospital environment is anxiety due to pain and fear.
Children can experience pain in all healthcare settings. Almost all diagnostic and therapeutic applications cause pain. It is also known that children experience more fear in the hospital environment than adults. Among the biggest fears children experience in the hospital environment are; Losing body functions, having surgery can be counted as painful invasive procedures performed for diagnosis and treatment. Especially made using a needle such as an injector; Procedures such as vaccination, bloodletting, and IV catheterization may cause pain and fear in children.
More than 80% of children admitted to hospitals are administered IV catheters. Almost all children are adversely affected by this process. In reducing these negative emotions experienced, it is very important to prepare children for the procedure. Control of pain and fear; requires cooperation between physicians, nurses and other health professionals. Especially nurses have important duties in this regard, as they have the opportunity to observe the patient closely and for a longer period of time. The American Association of Pain Management Nursing (ASPMN) also reports that nurses are responsible for controlling pain using pharmacological and non-pharmacological methods before, during and after painful intervention. For this purpose, therapeutic play can be used.
Therapeutic play is a type of play used to reduce the child's fear and stress towards the hospital, to alleviate the feeling of uncertainty, to evaluate misunderstandings about the hospital environment and the interventions applied in the hospital, to teach clinical procedures and to reduce pain in painful procedures. Ensuring that the child touches the tools and equipment to be used in the treatment during the game played in the hospital allows him to recognize them and perceive them as less threatening. At the same time, it improves the feeling of trust towards the health professional. Particularly, when preparation for play-based treatment is combined with treatment, the child can better tolerate painful procedures by developing positive coping methods. As a matter of fact, in the experimental study of Uluışık (2019) with 60 children aged 5-6 years, it was seen that the information provided with the play dough consisting of a dentist set reduced dental fear. In a randomized controlled study conducted by Miller et al. (2016) with 98 children aged 3-12, using an electronic device called Ditto (Diversionary Therapy Technologies, Brisbane, Australia) that provides procedural preparation and distraction during the vascular access procedure, significantly reduced stress. In another study conducted by Tunç Tuna and Açikgoz (2015) on 60 children aged 9-12, it was found that pre-procedural information on preparation for the peripheral venous cannula application in children and performing the procedure by showing it on the toy reduced the child's pain and anxiety. In the study conducted by Tunç Tuna and Açikgöz, real IV catheters were used in preparation for the procedure before the peripheral cannula application of the children. However, giving such tools and equipment to the hands of especially small children and having them applied can be dangerous and harmful for them. Instead, alternative methods should be developed.For example, the process can be explained through pictures and/or the toys/models of the tools to be used in the process can be given to children and practice can be made. In the literature review, no study could be found on the preparation of the child for the procedure with realistic toys before the IV catheterization procedure.
- Conditions
- Intravenous Catheterization
- Being tested
- Children Preparation With a Toy IV Catheter Before Peripheral Cannula application
- Keywords
- Toy, Therapeutic play, Preparation, Pain, Fear
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children Preparation With a Toy IV Catheter Before Peripheral Cannula applicationOther
THE EFFECT OF PROCESSING PREPARATION WITH A TOY IV CATHETER BEFORE PERIPHERAL CANNULA APPLICATION ON CHILDREN'S PAIN, FEAR and EMOTIONAL INDICATORS
| Study group | Role | What they receive |
|---|---|---|
| Toy IV Catheter Before Peripheral Cannula application | Experimental | Intervention Group: Child Fear Scale will be applied to the children who will meet the inclusion criteria. The data collection form will be filled in by the researcher according to the information received from the patient file and parents. Children in the intervention group will be shown the procedure on the doll with the IV Catheter developed by the researchers, and then it will be applied to it. Receives: Other: Children Preparation With a Toy IV Catheter Before Peripheral Cannula application |
| Standard of care | No intervention | Control group will not be aplied other than the normal procedure of the hospital. In both groups, at the end of the procedure, the child's reactions will be observed during the procedure and the Wong-Baker Faces Pain Scale, the Child Anxiety Scale and the Child Emotional Indicators Scale will be filled independently by the researcher and the parent in line with the child's reactions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal data collection form
The data collection form was prepared by the researchers in line with the literature (Başkaya, 2019; Gültekin, 2019; Szeszak et al., 2016; Tunç Tuna \& Açıkgoz 2015). In this form, 3 including the personal characteristics of the child, 9 questioning the illness and hospital experiences; There are 22 questions in total, 10 of which include parent and family characteristics.
Measured: 1.5 month
Wong-Baker faces pain scale
The scale is based on measuring the level of pain by scoring facial expressions of children aged 3-18. There is a numerical value for each facial expression in the scale. This numerical value gives us information about the child's pain level. The lowest numerical value is "0" and the highest numerical value is "5". A high score on the scale indicates a high level of pain. The application of the scale is quite simple. Faces and numbers are explained to the child and asked to choose the face that best expresses his or her pain. This scale was used by the researcher to evaluate the pain of children before the procedure. In addition, in order to determine the pain felt by the child during the procedure after the procedure, it was filled out independently by the child, parent and researcher.
Measured: 1.5 month
Child Fear Scale
The scale was developed by Mc Murtry et al. in 2011 to determine the anxiety level of children aged 5-10 years. There are various facial expressions in the scale and a numerical value is given for each facial expression. The lowest score obtained from the scale is "0" and the highest score is "4". The higher the score obtained from the scale, the higher the level of anxiety felt in the child. This scale was used by the researcher, parent and child to evaluate the anxiety of children before the procedure. After the procedure, it was filled again independently by the child, parent and researcher to determine the anxiety felt by the child during the procedure.
Measured: 1.5 month
Child Emotional Manifestation Scale
In the scale, emotional indicators are evaluated in terms of 5 parameters. These parameters are; facial expression, voice, activity, interaction and cooperation level. These five parameters are scored from 1 to 5, and the lowest "5" and the highest "25" points are obtained at the end of the evaluation of the scale. A low score from the scale indicates a positive emotional state, and an increase in a score indicates a negative emotional state. This scale was filled in independently by the parent and the researcher in order to evaluate the emotional indicators of the child during the procedure after the procedure.
Measured: 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start14 Jul 2020
- Primary completion15 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous CatheterizationStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal USLU, Eskisehir Osmangazi University
- Investigators
- Hazal USLU, Study director, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747833
- Sponsor's protocol ID
- 10346826
- Status last verified
- Feb 2023
- First submitted
- 26 Dec 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: The Effect of Preparation for Procedure With Toy IV Catheter Before Peripheral Cannula Administration on Children's Pain, Fear, and Emotional Indicators
- ClinicalTrials.gov ID
- NCT05747833
- Acronym / sponsor ID
- 10346826
- Conditions
- Intravenous Catheterization
- Keywords
- Toy, Therapeutic play, Preparation, Pain, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Feb 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.
Aim: Research was conducted to determine the effect of preparation for the procedure with a toy IV catheter before IV catheterization in children aged 6-10 years, on children's pain, fear and emotional indicators.
Methods: It is a randomized controlled intervention study. The study was completed with 80 children. There are two groups in the study. Before the IV catheterization, the children in the intervention group were treated with the toy IV catheter developed by the researchers on the knitted doll, and then the procedure was provided to them. Conversely, no intervention was applied to the control group other than the normal procedure of the hospital. Stratified block randomization method was used to assign children to groups. In the study; "Personal Data Collection Form", "Wong-Baker Faces Pain Scale (WBFPS)", "Child Fear Scale (CFS)" and "Child Emotional Manifestation Scale (CEMS)" were used to collect data.
Detailed description
Children may be sick during their normal development and may have to come to the hospital. For children, the hospital environment, especially emergency rooms, conveys uncertainty. The reason for this uncertainty; the presence of health team members that children do not know, equipment they have not seen before, and interventions. The child's sense of uncertainty and the thought that his own control is in danger may cause him to become stressed and afraid of the hospital. As a matter of fact, studies on children's hospital experience indicate that they experience negative emotions such as stress, anger, restlessness, and tension. It is known that the most common negative emotion and experience children experience in the hospital environment is anxiety due to pain and fear.
Children can experience pain in all healthcare settings. Almost all diagnostic and therapeutic applications cause pain. It is also known that children experience more fear in the hospital environment than adults. Among the biggest fears children experience in the hospital environment are; Losing body functions, having surgery can be counted as painful invasive procedures performed for diagnosis and treatment. Especially made using a needle such as an injector; Procedures such as vaccination, bloodletting, and IV catheterization may cause pain and fear in children.
More than 80% of children admitted to hospitals are administered IV catheters. Almost all children are adversely affected by this process. In reducing these negative emotions experienced, it is very important to prepare children for the procedure. Control of pain and fear; requires cooperation between physicians, nurses and other health professionals. Especially nurses have important duties in this regard, as they have the opportunity to observe the patient closely and for a longer period of time. The American Association of Pain Management Nursing (ASPMN) also reports that nurses are responsible for controlling pain using pharmacological and non-pharmacological methods before, during and after painful intervention. For this purpose, therapeutic play can be used.
Therapeutic play is a type of play used to reduce the child's fear and stress towards the hospital, to alleviate the feeling of uncertainty, to evaluate misunderstandings about the hospital environment and the interventions applied in the hospital, to teach clinical procedures and to reduce pain in painful procedures. Ensuring that the child touches the tools and equipment to be used in the treatment during the game played in the hospital allows him to recognize them and perceive them as less threatening. At the same time, it improves the feeling of trust towards the health professional. Particularly, when preparation for play-based treatment is combined with treatment, the child can better tolerate painful procedures by developing positive coping methods. As a matter of fact, in the experimental study of Uluışık (2019) with 60 children aged 5-6 years, it was seen that the information provided with the play dough consisting of a dentist set reduced dental fear. In a randomized controlled study conducted by Miller et al. (2016) with 98 children aged 3-12, using an electronic device called Ditto (Diversionary Therapy Technologies, Brisbane, Australia) that provides procedural preparation and distraction during the vascular access procedure, significantly reduced stress. In another study conducted by Tunç Tuna and Açikgoz (2015) on 60 children aged 9-12, it was found that pre-procedural information on preparation for the peripheral venous cannula application in children and performing the procedure by showing it on the toy reduced the child's pain and anxiety. In the study conducted by Tunç Tuna and Açikgöz, real IV catheters were used in preparation for the procedure before the peripheral cannula application of the children. However, giving such tools and equipment to the hands of especially small children and having them applied can be dangerous and harmful for them. Instead, alternative methods should be developed.For example, the process can be explained through pictures and/or the toys/models of the tools to be used in the process can be given to children and practice can be made. In the literature review, no study could be found on the preparation of the child for the procedure with realistic toys before the IV catheterization procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toy IV Catheter Before Peripheral Cannula application | Experimental | Other: Children Preparation With a Toy IV Catheter Before Peripheral Cannula applicationIntervention Group: Child Fear Scale will be applied to the children who will meet the inclusion criteria. The data collection form will be filled in by the researcher according to the information received from the patient file and parents. Children in the intervention group will be shown the procedure on the doll with the IV Catheter developed by the researchers, and then it will be applied to it. |
| Standard of care | No intervention | –Control group will not be aplied other than the normal procedure of the hospital. In both groups, at the end of the procedure, the child's reactions will be observed during the procedure and the Wong-Baker Faces Pain Scale, the Child Anxiety Scale and the Child Emotional Indicators Scale will be filled independently by the researcher and the parent in line with the child's reactions. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Your child;
- Age between 6-10,
- To receive IV treatment upon the request of a physician,
- Being conscious and able to communicate verbally,
- Understanding and speaking Turkish,
Key exclusion criteria (10 listed)
- Your child;
- Being younger than 6 and over 10 years old,
- Having pain,
- Having a high fever (body temperature of 38 ° C and above) Applying to the hospital with a complaint that requires urgent intervention such as convulsion or trauma,
- Having applied to the hospital by ambulance,
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 |
|---|---|---|
| Children Preparation With a Toy IV Catheter Before Peripheral Cannula applicationTHE EFFECT OF PROCESSING PREPARATION WITH A TOY IV CATHETER BEFORE PERIPHERAL CANNULA APPLICATION ON CHILDREN'S PAIN, FEAR and EMOTIONAL INDICATORS | Other | Toy IV Catheter Before Peripheral Cannula application |
Primary outcome
Personal data collection form
Time frame: 1.5 month
The data collection form was prepared by the researchers in line with the literature (Başkaya, 2019; Gültekin, 2019; Szeszak et al., 2016; Tunç Tuna \& Açıkgoz 2015). In this form, 3 including the personal characteristics of the child, 9 questioning the illness and hospital experiences; There are 22 questions in total, 10 of which include parent and family characteristics.
Wong-Baker faces pain scale
Time frame: 1.5 month
The scale is based on measuring the level of pain by scoring facial expressions of children aged 3-18. There is a numerical value for each facial expression in the scale. This numerical value gives us information about the child's pain level. The lowest numerical value is "0" and the highest numerical value is "5". A high score on the scale indicates a high level of pain. The application of the scale is quite simple. Faces and numbers are explained to the child and asked to choose the face that best expresses his or her pain. This scale was used by the researcher to evaluate the pain of children before the procedure. In addition, in order to determine the pain felt by the child during the procedure after the procedure, it was filled out independently by the child, parent and researcher.
Child Fear Scale
Time frame: 1.5 month
The scale was developed by Mc Murtry et al. in 2011 to determine the anxiety level of children aged 5-10 years. There are various facial expressions in the scale and a numerical value is given for each facial expression. The lowest score obtained from the scale is "0" and the highest score is "4". The higher the score obtained from the scale, the higher the level of anxiety felt in the child. This scale was used by the researcher, parent and child to evaluate the anxiety of children before the procedure. After the procedure, it was filled again independently by the child, parent and researcher to determine the anxiety felt by the child during the procedure.
Child Emotional Manifestation Scale
Time frame: 1.5 month
In the scale, emotional indicators are evaluated in terms of 5 parameters. These parameters are; facial expression, voice, activity, interaction and cooperation level. These five parameters are scored from 1 to 5, and the lowest "5" and the highest "25" points are obtained at the end of the evaluation of the scale. A low score from the scale indicates a positive emotional state, and an increase in a score indicates a negative emotional state. This scale was filled in independently by the parent and the researcher in order to evaluate the emotional indicators of the child during the procedure after the procedure.
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 28 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Hazal USLU study director
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children Preparation With a Toy IV Catheter Before Peripheral Cannula application in people with Intravenous Catheterization, run by Eskisehir Osmangazi 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 9 inclusion and 10 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 28 Feb 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?
Personal data collection form (time frame: 1.5 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.