Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 7:37 AM
Study NCT ID:
NCT04631094
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2020-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Two Different Structured Balls on Pain and Fear Levels During Venous Blood Collection in Children
Sponsor:
Zeynep Yurdakul
Organization:
Study Overview
Official Title:
Nurse, PhD Student, Responsible Researcher
Status:
COMPLETED
Status Verified Date:
2025-03
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:
Pain causes many physiological and psychological changes in the body, increases the level of anxiety in children, and prolongs examination and other procedures. Pain should be evaluated individually for each child, taking into account individual differences in pain level and response to pain. From the moment of birth, human beings have been exposed to many invasive interventions throughout their lives and experience pain and anxiety as a result. Experiences with childhood pain shape children's future pain responses.
This study, which was planned to stimulate the touch receptors of two different balls used during venous blood collection, is a randomized controlled study in order to determine the effect on the pain and fear levels of children aged 6-12 years. A total of 310 children were included in the study. The experimental groups included in the study were asked to hold the balls with their hands according to their groups, no attempt was made to the control group. The research data were obtained with the Wong-Baker Faces Pain Rating Scale and Child Fear Scale, which will be used in the evaluation. In addition, oxygen saturation and heart rate were evaluated immediately before and after removal of the tourniquet.
This study, which was planned to stimulate the touch receptors of two different balls used during venous blood collection, is a randomized controlled study in order to determine the effect on the pain and fear levels of children aged 6-12 years. A total of 310 children were included in the study. The experimental groups included in the study were asked to hold the balls with their hands according to their groups, no attempt was made to the control group. The research data were obtained with the Wong-Baker Faces Pain Rating Scale and Child Fear Scale, which will be used in the evaluation. In addition, oxygen saturation and heart rate were evaluated immediately before and after removal of the tourniquet.
Detailed Description:
Attempt During the trial, all blood collection procedures will be performed by the same nurse working in the hospital's blood collection unit. The nurse who will perform the procedure works as a pediatric nurse for 15 years.
Control Group;
* Data on the child and his parents will be collected by the researcher using face-to-face interview technique and recorded in the "Information Form".
* The child and parent will be informed by showing the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and the pulse oximeter.
* Disinfectant will be poured on the child's and parent's hands.
* Before the blood draw, the child will be given the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and a pen, and will be asked to mark the facial expression appropriate to his current situation.
* The child who filled out the form will be taken to the blood collection room with his parents, and the child will be seated on the blood collection chair. The child and parent will be informed about the blood collection procedure according to the hospital procedure.
* Due to the pandemic, in accordance with the hospital procedure, the tourniquet will be disinfected and used after each blood collection.
* The nurse will determine the child's extremity suitable for vascular access.
* Standard hospital procedures will be applied throughout the blood collection procedure.
* Immediately after the procedure, the child will be asked to mark the appropriate facial expression on the Wong-Baker Faces Pain Rating Scale and the Child Fear Scale during the procedure.
* Disinfectant will be poured on the child's and parent's hands.
* The child whose blood collection process is completed, and his parents will be thanked for their acceptance to participate in the research and will be ensured to leave the room.
Experimental Groups;
* Data on the child and his parents will be collected by the researcher using face-to-face interview technique. It will be saved in the "Information Form".
* The child and parent will be informed by showing the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and the pulse oximeter.
* Disinfectant will be poured on the child's and parent's hands.
* Before the blood draw, the child will be given the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and a pen, and will be asked to mark the facial expression appropriate to his current situation.
* The child who filled out the form will be taken to the blood collection room with his parents, and the child will be seated on the blood collection chair. The child and parent will be informed about the blood collection procedure according to the hospital procedure.
* Due to the pandemic, in accordance with the hospital procedure, the tourniquet will be disinfected and used after each blood collection.
* The nurse will determine the child's extremity suitable for vascular access.
* According to randomization, the child was able to hold the ball according to the group (Group 1, Group 2, Group 3, Group 4).
* Group 1: Serrated ball + extremity group from which venous blood will be taken
* Group 2: Serrated ball + hand group on the opposite side of the extremity from which venous blood will be taken
* Group 3: Straight ball + extremity group from which venous blood will be taken
* Group 4: Flat ball + hand group on the opposite side of the extremity from which venous blood will be taken
* Control group: Group to be applied standard hospital blood collection procedure
* Standard hospital procedures will be applied throughout the blood collection procedure.
* Immediately after the procedure, the child will be asked to mark the appropriate facial expression on the Wong-Baker Faces Pain Rating Scale and the Child Fear Scale during the procedure.
* Disinfectant will be poured on the child's and parent's hands.
* The child whose blood collection process is completed, and his parents will be thanked for their acceptance to participate in the research and will be ensured to leave the room.
Control Group;
* Data on the child and his parents will be collected by the researcher using face-to-face interview technique and recorded in the "Information Form".
* The child and parent will be informed by showing the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and the pulse oximeter.
* Disinfectant will be poured on the child's and parent's hands.
* Before the blood draw, the child will be given the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and a pen, and will be asked to mark the facial expression appropriate to his current situation.
* The child who filled out the form will be taken to the blood collection room with his parents, and the child will be seated on the blood collection chair. The child and parent will be informed about the blood collection procedure according to the hospital procedure.
* Due to the pandemic, in accordance with the hospital procedure, the tourniquet will be disinfected and used after each blood collection.
* The nurse will determine the child's extremity suitable for vascular access.
* Standard hospital procedures will be applied throughout the blood collection procedure.
* Immediately after the procedure, the child will be asked to mark the appropriate facial expression on the Wong-Baker Faces Pain Rating Scale and the Child Fear Scale during the procedure.
* Disinfectant will be poured on the child's and parent's hands.
* The child whose blood collection process is completed, and his parents will be thanked for their acceptance to participate in the research and will be ensured to leave the room.
Experimental Groups;
* Data on the child and his parents will be collected by the researcher using face-to-face interview technique. It will be saved in the "Information Form".
* The child and parent will be informed by showing the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and the pulse oximeter.
* Disinfectant will be poured on the child's and parent's hands.
* Before the blood draw, the child will be given the Wong-Baker Faces Pain Rating Scale, the Child Fear Scale, and a pen, and will be asked to mark the facial expression appropriate to his current situation.
* The child who filled out the form will be taken to the blood collection room with his parents, and the child will be seated on the blood collection chair. The child and parent will be informed about the blood collection procedure according to the hospital procedure.
* Due to the pandemic, in accordance with the hospital procedure, the tourniquet will be disinfected and used after each blood collection.
* The nurse will determine the child's extremity suitable for vascular access.
* According to randomization, the child was able to hold the ball according to the group (Group 1, Group 2, Group 3, Group 4).
* Group 1: Serrated ball + extremity group from which venous blood will be taken
* Group 2: Serrated ball + hand group on the opposite side of the extremity from which venous blood will be taken
* Group 3: Straight ball + extremity group from which venous blood will be taken
* Group 4: Flat ball + hand group on the opposite side of the extremity from which venous blood will be taken
* Control group: Group to be applied standard hospital blood collection procedure
* Standard hospital procedures will be applied throughout the blood collection procedure.
* Immediately after the procedure, the child will be asked to mark the appropriate facial expression on the Wong-Baker Faces Pain Rating Scale and the Child Fear Scale during the procedure.
* Disinfectant will be poured on the child's and parent's hands.
* The child whose blood collection process is completed, and his parents will be thanked for their acceptance to participate in the research and will be ensured to leave the room.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: