Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05252494
Status:
UNKNOWN
Last Update Posted:
2022-02-23
First Post:
2022-01-11
Brief Title:
The Effect Of Getting Children Between 3-6 To Watch Small Aquarium Fish On Physiological Parameters Pain and Stress During Blood Collection
Sponsor:
Uskudar University
Organization:
Uskudar University
Study Overview
Official Title:
The Effect Of Getting Children Between 3-6 To Watch Small Aquarium Fish On Physiological Parameters Pain and Stress During Blood Collection
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
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:
Disease patterns are different from adults due to the fact that the abstract thinking and cause-effect abilities of children in the 3-6 age group are not developed Children in this age group Their ability to cope with stress is limited due to the need for special care life experiences mental development and inadequate ability to express themselves verbally Conk et al 2013 Illness is a source of pain and stress for them due to external factors and is a punishment for their bad behavior Conk et al 2013 Teksöz Ocakçı 2014Hospital on the other hand means foreign environmentpersons loss of independence loss of privacy painful procedures disruption of daily routines surgery pain disability death separation from family and friends for children Conk et al 2013 Blood collection and vascular access are the interventions that cause the most pain stress and anxiety in hospitalized children Duff 2003 Caprilli et al 2007 Non-invasive non-pharmacological methods increase the release of endorphins the bodys natural morphine and relieve pain thereby reducing the stress and anxiety of the child and family Bergomi et al 2018 Clinical experience argues that human-animal bonding which is one of the distraction practices in pain management is effective in reducing pain and stress Muslu 2011 Min Zaw 2016 Alvarez et al 2020
In the light of all this information The aim of this study was to determine the effect of watching small aquarium fish which is used as a distraction method during the blood collection process on the pain and stress heart rate and oxygen saturation during the procedure in children aged 3-6 years who applied to the blood collection unit
Hypotheses of the Research
Hypothesis 0 H0 Feelings felt by children watching and not watching fish during blood collection there was no difference between stress pain score heart rate oxygen saturation crying and procedure time
Hypothesis 1 H1 The oxygen saturation of the children who watched the fish during the blood collection process is high
Hypothesis 2 H2 Children watching the fish during the blood draw have a higher heart rate is low
Hypothesis 3 H3 Children who watched the fish during the blood draw had a higher pain score is low
Hypothesis 4 H4 The stress score of the children who watched the fish during the blood collection process was higher is low
Hypothesis 5 H5 The crying time of the children watching the fish during the blood collection process is longer is short
Hypothesis 6 H6 The processing time is longer for children watching the fish during the blood collection process is short
In the light of all this information The aim of this study was to determine the effect of watching small aquarium fish which is used as a distraction method during the blood collection process on the pain and stress heart rate and oxygen saturation during the procedure in children aged 3-6 years who applied to the blood collection unit
Hypotheses of the Research
Hypothesis 0 H0 Feelings felt by children watching and not watching fish during blood collection there was no difference between stress pain score heart rate oxygen saturation crying and procedure time
Hypothesis 1 H1 The oxygen saturation of the children who watched the fish during the blood collection process is high
Hypothesis 2 H2 Children watching the fish during the blood draw have a higher heart rate is low
Hypothesis 3 H3 Children who watched the fish during the blood draw had a higher pain score is low
Hypothesis 4 H4 The stress score of the children who watched the fish during the blood collection process was higher is low
Hypothesis 5 H5 The crying time of the children watching the fish during the blood collection process is longer is short
Hypothesis 6 H6 The processing time is longer for children watching the fish during the blood collection process is short
Detailed Description:
The universe of the research will be all children brought to a training and research hospital for blood transfusion between March 2022 and March 2023 The sample of the study will be the children of parents who comply with the sample selection criteria and volunteer to participate in the research
In order to determine the number of samples power analysis was performed using the GPower v317 program The power of the study is expressed as 1-β β probability of type II error and in general studies should have 80 power Based on the pain measurement differences before and after the procedure in Carie Brauns study to evaluate the pain during blood collection difference of the means for the control group 031 the difference of the mean for the experimental group was 161 the effect size was calculated to obtain 80 power at the α005 level d 0748 was found According to this it was calculated that there should be at least 30 people in each group and 60 people in total Considering that there may be losses during the study process it was decided to take at least 35 people in each group
Data Collection Tools and Materials The following tools and forms will be used in the collection of research data Informed Voluntary Consent Form Appendix 1 Before starting the research all childrens parents should be informed about the purpose plan duration of the research how the obtained data will be used Voluntary Information and Consent Form and verbal and written permissions will be obtained Parents who agree to participate in the study will be told that they can withdraw from the study at any time they will be assured that the individual information obtained will not be disclosed to anyone other than the researcher and that no fees will be charged to the parents or that no research expense will be charged to the social security institution to which the patient is affiliated
Information Form Appendix 2 It was prepared by scanning the literature on the subject The information form is the form in which the childs name surname group introductory information about the parents and the child are recorded The information form will be filled by the researcher himself by face-to-face interview method Follow-up Form Appendix 3 It was prepared by scanning the literature on the subject The follow-up form is the form in which the childs pain and stress score physiological parameters crying and duration of the procedure are recorded The follow-up form will be filled in by the researcher himself in line with the findings obtained from the patient during data collection
Pain Assessment Tool FLACC Appendix 4
It was developed by Merkel 1997 and Turkish validity and reliability was done by Şenaylı et al 2006 Each of the babys facial expression leg movements activity crying and comfortability parameters consists of three sub-items and can be applied to children aged 1 month to 9 years The items take the value 0 1 2 respectively and the total score is between 0 and 10 A 0 score indicates no pain 1-3 points mild 4-6 points moderate and 7-10 points severe pain In order to use the FLACC pain assessment scale permission was obtained from Şenaylı et al via e-mail
Wong and Baker Faces Pain Scale Wong-Baker Faces Pain Rating Scale WBFPRS Appendix 5 This scale was developed by Donna Wong and Connie Morain Baker in 1988 This scale is used to diagnose pain in children aged 3-18 years Studies comparing this tool with others have reported that children like the facial expressions rating scale and that it provides the most accurate pain measurement In this scale pain scores are given according to the numerical values given to the faces The lowest score is 1 and the highest score is 5 As the score obtained from the scale increases the pain tolerance decreases and as the score decreases the tolerance increases
Childrens Emotional Manifestation Scale-CEMS Appendix 6 Childrens Emotional Expression Evaluation Scale The scale which was developed by Ho Cheung William Li Childrens Emotional Manifestation Scale-CEMS in 2003 and validated in Turkish by Yanık and Ark 2019 consists of a total of 5 different categories and 25 items This scale evaluates the anxiety experienced by children during medical procedures In the facial expression category of the first 5 items the facial expressions of the child observed by the researcher are scored Secondly the childs tear state is evaluated over 5 sub-items in the vocalization category Third in the 5 sub-items of the movement title the childs body language is scored Fourth the childs verbal or non-verbal communication is evaluated in 5 sub-items in the interaction category Fifth scoring is done by observing the active or passive participation of the child in the 5 sub-items of the cooperation category 1-5 points in each category
In order to determine the number of samples power analysis was performed using the GPower v317 program The power of the study is expressed as 1-β β probability of type II error and in general studies should have 80 power Based on the pain measurement differences before and after the procedure in Carie Brauns study to evaluate the pain during blood collection difference of the means for the control group 031 the difference of the mean for the experimental group was 161 the effect size was calculated to obtain 80 power at the α005 level d 0748 was found According to this it was calculated that there should be at least 30 people in each group and 60 people in total Considering that there may be losses during the study process it was decided to take at least 35 people in each group
Data Collection Tools and Materials The following tools and forms will be used in the collection of research data Informed Voluntary Consent Form Appendix 1 Before starting the research all childrens parents should be informed about the purpose plan duration of the research how the obtained data will be used Voluntary Information and Consent Form and verbal and written permissions will be obtained Parents who agree to participate in the study will be told that they can withdraw from the study at any time they will be assured that the individual information obtained will not be disclosed to anyone other than the researcher and that no fees will be charged to the parents or that no research expense will be charged to the social security institution to which the patient is affiliated
Information Form Appendix 2 It was prepared by scanning the literature on the subject The information form is the form in which the childs name surname group introductory information about the parents and the child are recorded The information form will be filled by the researcher himself by face-to-face interview method Follow-up Form Appendix 3 It was prepared by scanning the literature on the subject The follow-up form is the form in which the childs pain and stress score physiological parameters crying and duration of the procedure are recorded The follow-up form will be filled in by the researcher himself in line with the findings obtained from the patient during data collection
Pain Assessment Tool FLACC Appendix 4
It was developed by Merkel 1997 and Turkish validity and reliability was done by Şenaylı et al 2006 Each of the babys facial expression leg movements activity crying and comfortability parameters consists of three sub-items and can be applied to children aged 1 month to 9 years The items take the value 0 1 2 respectively and the total score is between 0 and 10 A 0 score indicates no pain 1-3 points mild 4-6 points moderate and 7-10 points severe pain In order to use the FLACC pain assessment scale permission was obtained from Şenaylı et al via e-mail
Wong and Baker Faces Pain Scale Wong-Baker Faces Pain Rating Scale WBFPRS Appendix 5 This scale was developed by Donna Wong and Connie Morain Baker in 1988 This scale is used to diagnose pain in children aged 3-18 years Studies comparing this tool with others have reported that children like the facial expressions rating scale and that it provides the most accurate pain measurement In this scale pain scores are given according to the numerical values given to the faces The lowest score is 1 and the highest score is 5 As the score obtained from the scale increases the pain tolerance decreases and as the score decreases the tolerance increases
Childrens Emotional Manifestation Scale-CEMS Appendix 6 Childrens Emotional Expression Evaluation Scale The scale which was developed by Ho Cheung William Li Childrens Emotional Manifestation Scale-CEMS in 2003 and validated in Turkish by Yanık and Ark 2019 consists of a total of 5 different categories and 25 items This scale evaluates the anxiety experienced by children during medical procedures In the facial expression category of the first 5 items the facial expressions of the child observed by the researcher are scored Secondly the childs tear state is evaluated over 5 sub-items in the vocalization category Third in the 5 sub-items of the movement title the childs body language is scored Fourth the childs verbal or non-verbal communication is evaluated in 5 sub-items in the interaction category Fifth scoring is done by observing the active or passive participation of the child in the 5 sub-items of the cooperation category 1-5 points in each category
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