Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747833
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2022-12-26
Brief Title:
The Effect of Toy IV Catheter on Childrens Pain Fear and Emotional Indicators
Sponsor:
Eskisehir Osmangazi University
Organization:
Eskisehir Osmangazi University
Study Overview
Official Title:
Randomized Controlled Trial The Effect of Preparation for Procedure With Toy IV Catheter Before Peripheral Cannula Administration on Childrens Pain Fear and Emotional Indicators
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childrens 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
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 childs 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 childrens 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 childs 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 childs 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 developedFor example the process can be explained through pictures andor the toysmodels 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
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 childs 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 childs 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 developedFor example the process can be explained through pictures andor the toysmodels 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None