Clinical trial NCT04631094: The Effect of Two Different Structured Balls on Pain and Fear Levels During Venous Blood Collection in Children
Official title: Nurse, PhD Student, Responsible Researcher
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Keywords: child, fear, nursing, pain, venipuncture
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 310
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* - The volunteerism of the child and the parent to participate in the research,
* The child is between the ages of 5-12,
* The child and the parent speaks Turkish, Taking blood from the cephalic vein,
* Turnstile not being tied for more than 30 seconds,
* Not taking any analgesic (systemic or topical), antipyretic, anti-inflammatory drugs in the last 12 hours,
* Body temperature between 36.5-37.2 ⁰C,
* Not having a disease that can cause chronic pain,
* No acute pain or anxiety during the procedure,
* Absence of skin integrity problems,
* No obstacle to grip the balls in hand,
* Children who do not have regular invasive interventions (no chronic diseases that require blood control such as cancer, diabetes),
* Blood collection was performed at the first attempt,
* The child does not have any auditory, mental or neurological disability that will affect his participation in the research.

Exclusion Criteria:

* - The child and the parents are not willing to participate in the research,
* The child is not between the ages of 5-12,
* The child and the parent do not speak Turkish, Inability to take blood from the cephalic vein,
* Turnstile remaining tied for more than 30 seconds,
* Taking any medication with analgesic (systemic or topical), antipyretic or anti-inflammatory effects in the last 12 hours,
* Body temperature lower than 36.5 C-37.2 ⁰C,
* Having a disease that can cause chronic pain,
* Children who undergo regular invasive interventions (having chronic diseases that require blood control such as cancer, diabetes), Failure to take blood at the first attempt,
* Any acute pain or anxiety during the procedure,
* Problems with skin integrity,
* It has an obstacle to grip the balls,
* Having an auditory, mental or neurological disability that will affect the child's participation in the research,
* Children in the control group want or involuntarily hold their parent's hand or something else during the procedure.

Primary outcomes:
measure: Pain level as assessed with Wong-Baker Faces Pain Rating Scale
timeFrame: during the procedure
measure: Fear as assessed using the Child Fear Scale
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: assistant professor
name: Figen Işık ESENAY
role: STUDY_DIRECTOR
References: