Ankara University
Ankara, 06000, Turkey (Türkiye)
NCT Number: NCT04631094
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.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Ankara, 06000, Turkey (Türkiye)
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;
Experimental Groups;
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children in the experimental groups will squeeze the serrated ball during the blood draw.
Other names: serrated ball
Children in the experimental groups will squeeze the serrated ball during the blood draw.
Other names: serrated ball
Children in the experimental groups will squeeze the smooth ball during the blood draw.
Other names: smooth ball
Children in the experimental groups will squeeze the smooth ball during the blood draw.
Other names: smooth ball
Time frame: during the procedure
This scale to be used to assess pain in our study was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. The scale is widely used to measure pain intensity in children over the age of three. Pain is scored according to numerical values assigned to faces that show an expression spectrum; smiling face represents no pain (0 points), crying face represents severe pain (10 points). The scale is a valid and reliable tool for measuring procedural pain severity. Permission for the scale was obtained from the official website of the Wong-Baker Faces Foundation. The Turkish translation of the scale was sent by Nick Baker, official site official of the Wong-Baker Faces Foundation.
Time frame: during the procedure
It is used to determine the child's fear and anxiety level. Fear and anxiety are assessed on a five-point scale. The single-item scale consists of five facial expressions regardless of gender. The first facial expression of the scale is neutral and has a value of zero. The last facial expression is worth four points expressing extreme fear. In this study, Child Fear Scale will be used to evaluate the fear levels of children in the experimental and control groups before and after the bloodletting procedure. The scale was introduced into the Turkish language by Gerçeker et al. (2018). Test-retest reliability of the Child Fear Scale was found to be quite high, and its content validity index was determined as 0.89. Since the scale is in the form of scoring, item-total correlation and Cronbach alpha coefficient could not be calculated.
Zeynep Yurdakul
Other
Nurse, PhD Student, Responsible Researcher
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