Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611605
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Effect of Storytelling with Metaphor Toys on Fear and Anxiety Levels in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Storytelling with Metaphor Toy Used During Venous Blood Collection on Fear and Anxiety Levels in Children Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hospital environment is an unfamiliar environment for children and unfamiliar people unknown medical tools and equipment sounds and medical procedures in this environment can cause negative emotional states such as fear and anxiety in them Venous blood collection is one of the most common invasive procedures applied to children who are hospitalized for routine health check-ups or for treatment and care This procedure can be traumatic enough to create negative emotional states in children and affect them even in their later lives This study was planned as a randomized controlled experimental study with pre-test-post-test measurements including intervention n 34 and control n 34 groups in order to reduce the fear and anxiety levels of children with the metaphor toy used during venous blood collection The Child Identification Form Children Fear Scale and Children Emotional Manifestation Scale will be used as data collection tools in the study 68 children between the ages of 7-10 who applied to Akdeniz University Hospital Pediatric Blood Collection Unit will constitute the universe of the research Data will be collected by face-to-face interview method after receiving institutional permission for the conduct of the research and parental consent After the final test data collection phase of the research is completed the obtained data will be analyzed using Statistical Package of Social Science SPSS 230 software package program The data evaluation process will be carried out with the support of a statistics expert It is predicted that the metaphor toy used during the venous blood collection process and storytelling will have lower fear and anxiety levels in the intervention group children compared to the control group children
Detailed Description:
This study was planned as a randomized controlled experimental study with pre-test-post-test measurements including intervention n 34 and control n 34 groups in order to reduce fear and anxiety levels in childrens by using a metaphor toy during venous blood collection The toy to be used in the study was developed by the researchers in order to metaphorize the blood collection process In the study the metaphor toy to be used during the blood collection process was used to narrate the bee collecting honey from a flower In this way the blood collection process which can cause fear and anxiety in children will be metaphorized The Child Identification Form Child Fear Scale and Children Emotional Manifestation Scale will be used as data collection tools in the study 68 children between the ages of 7-10 who applied to Akdeniz University Hospital Pediatric Blood Collection Unit will constitute the universe of the study Data will be collected by face-to-face interview method after receiving institutional permission for the conduct of the study and parental consent After the final test data collection phase of the study is completed the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The data evaluation process will be carried out with the support of a statistics expert It is anticipated that the storytelling with the metaphor toy used during the venous blood collection process will have lower fear and anxiety levels in the intervention group children compared to the control group children
Intervention Group The research will be implemented in stages Stage 1 Preliminary Implementation of the Research First Measurement A preliminary implementation was conducted with 5 children who met the inclusion criteria of the research in order to evaluate the comprehensibility and applicability of the surveys and storytelling with metaphor toys After the preliminary implementation the final version of the application was decided During the preliminary implementation a positive change was observed in the emotional states of the children who were applied the intervention after the storytelling with metaphor toys The children included in the preliminary implementation will not be included in the research sample
Stage 2 Application After randomization the pre-test will be applied by the researcher to the children included in the intervention group after obtaining consent from their parents
The pre-test will be applied to the child who meets the inclusion criteria for the study
Before the children included in the intervention group proceed to the blood collection process the story will be told to the child by the researcher in the waiting room of the Akdeniz University Hospital Blood Collection Unit through a metaphor toy The child and the parent will be together during the story telling The story presented below will be told to the child in the blood collection unit Expert opinions were obtained from five academics who completed their doctoral education in the field of Child Health and Disease Nursing for the content of the story
Stage 3 Post-Test Application Second Measurement and Evaluation The post-test Second Measurement application will be performed by the researcher immediately after the venous blood collection process is completed
After the post-test data collection phase of the study is completed the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The data evaluation process will be carried out with the support of a statistics expert
Control group
After the informed consent of the parent of the child included in the control group after randomization the pre-test First measurement will be applied by the researcher
No application will be made to the children included in the control group
The post-test Second Measurement will be applied by the researcher immediately after the venous blood collection process is completed
Data Collection Tools Child Fear Scale CFS The Child Fear Scale is used to measure the child fear level The CFS is a scale that evaluates from 0 to 4 consisting of five drawn facial expressions ranging from a neutral expression 0 no anxiety to a frightened face 4 severe anxiety and is intended for children aged 5-10 The Turkish validity and reliability study was conducted by Gerçeker et al in 2018 and this scale can be applied to measure fear before and during the procedure Permission for use of the scale will be obtained from the responsible author
Children Emotional Manifestation Scale CEMS CEMS was developed by Li Lopez in 2005 to provide nurses with a simple objective and consistent method for observing children emotional behaviors during stressful medical procedures The Cronbach alpha value of the scale was stated as 092 Validity and reliability are the most important features that measurement tools should have Scale adaptation studies include evaluating the reliability and validity of a scale developed in different cultures testing it in another language and culture and making it ready for use The Turkish validity and reliability study of this measurement tool was conducted by Cimke and Bayat in 2021 The Cronbach alpha value of the scale was stated as 094 The CEMS consists of 5 sections Facial Expressions Sounds Activity Interaction and Cooperation consisting of emotional behaviors based on observations In each section the child receives a score between 1-5 The total score that can be obtained from the scale is between 5 and 25 As the scores obtained from the scale increase negative emotional indicators increase in direct proportion
Measurement and evaluation of the effect In collecting the research data the Child Identification Form the Child Fear Scale and the Children Emotional Manifestation Scale will be used for children The same measurement tools will be used in collecting the pre-test and post-test data The intervention will be applied to the children in the intervention group included in the research after the necessary verbal and written permissions are obtained from their parents No intervention will be applied to the control group It is planned to apply two measurements a pre-test and a post-test to the children in the intervention and control groups After the completion of the post-test data collection phase of the research the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The data evaluation process will be carried out with the support of a statistics expert
Randomization There are 2 groups in the study 1 intervention group and 1 control group Simple blind randomization will be performed Randomization will be performed in the study using the closed envelope method 34 pieces of paper with intervention 1 and 34 pieces of control written on them will be placed in a closed envelope A nurse in the blood collection unit will be asked to select a paper from the envelope independent of the study Accordingly the child who accepts to participate in the study will be assigned to the intervention or control group
Blinding masking In order to ensure blinding in the assignment of the sample to the intervention and control groups children coming to the blood collection unit will be randomly assigned to groups Since the children assigned to the groups do not know the intervention of the child in the other group except themselves the sample group will be blinded In addition blinding in as many ways as possible is important for the quality and internal validity of the randomized controlled experimental study In this direction during the data analysis phase the database will be created by an expert independent of the research In order to minimize the risk of bias in the created database the intervention group will be coded as 1 and the control group as 2 in the SPSS 230 program The expert from whom statistical support is received will not be informed about the groups
Intervention Group The research will be implemented in stages Stage 1 Preliminary Implementation of the Research First Measurement A preliminary implementation was conducted with 5 children who met the inclusion criteria of the research in order to evaluate the comprehensibility and applicability of the surveys and storytelling with metaphor toys After the preliminary implementation the final version of the application was decided During the preliminary implementation a positive change was observed in the emotional states of the children who were applied the intervention after the storytelling with metaphor toys The children included in the preliminary implementation will not be included in the research sample
Stage 2 Application After randomization the pre-test will be applied by the researcher to the children included in the intervention group after obtaining consent from their parents
The pre-test will be applied to the child who meets the inclusion criteria for the study
Before the children included in the intervention group proceed to the blood collection process the story will be told to the child by the researcher in the waiting room of the Akdeniz University Hospital Blood Collection Unit through a metaphor toy The child and the parent will be together during the story telling The story presented below will be told to the child in the blood collection unit Expert opinions were obtained from five academics who completed their doctoral education in the field of Child Health and Disease Nursing for the content of the story
Stage 3 Post-Test Application Second Measurement and Evaluation The post-test Second Measurement application will be performed by the researcher immediately after the venous blood collection process is completed
After the post-test data collection phase of the study is completed the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The data evaluation process will be carried out with the support of a statistics expert
Control group
After the informed consent of the parent of the child included in the control group after randomization the pre-test First measurement will be applied by the researcher
No application will be made to the children included in the control group
The post-test Second Measurement will be applied by the researcher immediately after the venous blood collection process is completed
Data Collection Tools Child Fear Scale CFS The Child Fear Scale is used to measure the child fear level The CFS is a scale that evaluates from 0 to 4 consisting of five drawn facial expressions ranging from a neutral expression 0 no anxiety to a frightened face 4 severe anxiety and is intended for children aged 5-10 The Turkish validity and reliability study was conducted by Gerçeker et al in 2018 and this scale can be applied to measure fear before and during the procedure Permission for use of the scale will be obtained from the responsible author
Children Emotional Manifestation Scale CEMS CEMS was developed by Li Lopez in 2005 to provide nurses with a simple objective and consistent method for observing children emotional behaviors during stressful medical procedures The Cronbach alpha value of the scale was stated as 092 Validity and reliability are the most important features that measurement tools should have Scale adaptation studies include evaluating the reliability and validity of a scale developed in different cultures testing it in another language and culture and making it ready for use The Turkish validity and reliability study of this measurement tool was conducted by Cimke and Bayat in 2021 The Cronbach alpha value of the scale was stated as 094 The CEMS consists of 5 sections Facial Expressions Sounds Activity Interaction and Cooperation consisting of emotional behaviors based on observations In each section the child receives a score between 1-5 The total score that can be obtained from the scale is between 5 and 25 As the scores obtained from the scale increase negative emotional indicators increase in direct proportion
Measurement and evaluation of the effect In collecting the research data the Child Identification Form the Child Fear Scale and the Children Emotional Manifestation Scale will be used for children The same measurement tools will be used in collecting the pre-test and post-test data The intervention will be applied to the children in the intervention group included in the research after the necessary verbal and written permissions are obtained from their parents No intervention will be applied to the control group It is planned to apply two measurements a pre-test and a post-test to the children in the intervention and control groups After the completion of the post-test data collection phase of the research the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The data evaluation process will be carried out with the support of a statistics expert
Randomization There are 2 groups in the study 1 intervention group and 1 control group Simple blind randomization will be performed Randomization will be performed in the study using the closed envelope method 34 pieces of paper with intervention 1 and 34 pieces of control written on them will be placed in a closed envelope A nurse in the blood collection unit will be asked to select a paper from the envelope independent of the study Accordingly the child who accepts to participate in the study will be assigned to the intervention or control group
Blinding masking In order to ensure blinding in the assignment of the sample to the intervention and control groups children coming to the blood collection unit will be randomly assigned to groups Since the children assigned to the groups do not know the intervention of the child in the other group except themselves the sample group will be blinded In addition blinding in as many ways as possible is important for the quality and internal validity of the randomized controlled experimental study In this direction during the data analysis phase the database will be created by an expert independent of the research In order to minimize the risk of bias in the created database the intervention group will be coded as 1 and the control group as 2 in the SPSS 230 program The expert from whom statistical support is received will not be informed about the groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None