Clinical trial NCT05288309: The Effect Of Use Of Raınstick And Kaleydoscope On Paın Anxıety Durıng Blood Draw
Official title: The Effect Of Use Of Raınstick And Kaleydoscope On Paın Anxıety And Parent Satısfactıon Durıng Blood Draw In Chıldren: A Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Child, Only
Anxiety
Pain, Procedural
Keywords: Anxiety
Blood draw
children
Nursing
Pain
Rainstick
Kaleidoscope
Lead sponsor: Erzincan Binali Yildirim Universitesi
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 105
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Medical procedures are negative experiences that cause pain, distress, and anxiety and are not only uncomfortable during medical procedures, especially in children; negative consequences such as poor recovery, sleep disturbances, and post-traumatic stress symptoms. There are many different approaches, including pharmacological and non-pharmacological methods, for the treatment of pain and anxiety in children during medical procedures. Non-pharmacological methods vary depending on the child's age, level of development and the type of procedure, and non-pharmacological methods generally used in children fall into three groups: supportive, physical and cognitive or behavioral methods. Supportive methods are practices that include psychosocial care of the child, such as reading a book or playing games. Physical methods include techniques such as cold application, massage, and transcutaneous electrical nerve stimulation. Cognitive or behavioral methods include practices such as listening to music, daydreaming, relaxation, and various methods of distraction. Cognitive and behavioral approaches typically use the activating or relaxing effects of music for arousal or calming and to enhance the learning of certain skills and behaviors. Music therapy practice reduces pain and anxiety levels by stimulating the pituitary gland.

Another method used is the use of kaleidoscope. In the literature, they reported that the use of kaleidoscope is effective in reducing the pain that may occur during blood collection in studies conducted with preschool and school children, children and adolescents, and school-age children. The results show that the kaleidoscope can be used effectively to distract children from the painful procedure and reduce the perception of pain.

Detailed description: Data Collection After obtaining the necessary institutional permissions, parents and children will be informed about the research through the "Informed Voluntary Consent Form" in the interview room 15 minutes before the blood draw. Research data will be collected by the researcher by face-to-face interview technique. A questionnaire including questions such as the age of the child, the time of the last blood draw, the parent's presence with the child will be applied to the parents. To ensure randomisation, children will be asked to choose one of the sealed envelopes. Then, the blood collection room will be passed to perform the procedure.

When the child to be taken to Experimental Group 1 sits in the patient's chair, the sound of the rain stick will be played 1 minute before the blood draw. The nurse will then begin to prepare the child for the blood draw. The tourniquet insertion procedure and the determination of the vein from which blood will be drawn from the antecubital region will be performed by the nurse. Blood collection will be taken from the antecubital region at once by the same nurse through the vacuum blood collection tube, and blood flow to the vacuum within 5 seconds will show that the procedure is successful. In the meantime, a pulse oximeter will be attached to the index finger of the hand on the other arm, where blood is not drawn, and the heart rate will be evaluated before the procedure and after the procedure. This process will take about 2-3 minutes and the children will listen to the sound of the rain stick throughout the process. After the procedure is over, the children will be taken out of the blood collection room and taken to the waiting area, and they will be asked to determine the severity of pain they feel during the procedure. WBFPS will be used to find out how much pain the child has during the blood draw, and ÇAS-D will be used to determine the anxiety state. Pain and anxiety level will be evaluated by the child, nurse, parent and researcher.

The Kaleidoscope will start to be watched 1 minute before the blood draw process, as the child, who will be taken into Experimental Group 2, sits in the patient's chair. The nurse will then begin to prepare the child for the blood draw. The tourniquet insertion procedure and the determination of the vein from which blood will be drawn from the antecubital region will be performed by the nurse. Blood collection will be taken from the antecubital region at once by the same nurse through the vacuum blood collection tube, and blood flow to the vacuum within 5 seconds will show that the procedure is successful. In the meantime, a pulse oximeter will be attached to the index finger of the hand on the other arm, where blood is not drawn, and the heart rate will be evaluated before the procedure and after the procedure. This process will take about 2-3 minutes, and children will be shown a kaleidoscope image throughout the process. After the procedure is over, the children will be taken out of the blood collection room and taken to the waiting area, and they will be asked to determine the severity of pain they feel during the procedure. WBFPS will be used to find out how much pain the child has during the blood draw, and ÇAS-D will be used to determine the anxiety state. Pain and anxiety level will be evaluated by the child, nurse, parent and researcher.

No interventional procedure will be applied to the children in the control group. The blood collection will be arranged in such a way that it is taken from the antecubital region in one go by the same nurse by means of a vacutainer. In the meantime, a pulse oximeter will be attached to the index finger of the hand on the other arm, where blood is not drawn, and the heart rate will be evaluated before the procedure and after the procedure. After the procedure is over, the children will be taken out of the blood collection room and taken to the waiting area. WBFPS will be used to find out how much pain the child has during the blood draw, and ÇAS-D will be used to determine the anxiety state. Pain and anxiety level will be evaluated by the child, nurse, parent and researcher. In both groups, parents will be provided with their children in the blood collection room during the procedure.

Eligibility criteria: Inclusion Criteria:

* Must be between 5-12 years old
* There should be no pain before the blood draw procedure
* Should not have a chronic disease that will cause pain Blood should be taken from the antecubital region
* Must be willing to participate in the research

Exclusion Criteria:

* The transmission barrier
* Wearing glasses
* Involuntary

Primary outcomes:
measure: Comparison of Wong-Baker Faces Pain Scale Mean Scores by Groups
timeFrame: It will be evaluated within an average of 5 minutes during the blood collection process.
Secondary outcomes:
measure: Comparison of Child Anxiety Scale Mean Scores before and during the procedure according to the groups
timeFrame: It will be evaluated within an average of 3 minutes before the blood draw and an average of 3 minutes during the blood collection process.
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Erzincan Binali Yıldırım University
state: Erzi̇ncan
city: Merkez
country: Turkey
facility: Erzincan Binali Yıldırım Üniversitesi
state: Erzi̇ncan
Study officials:
References: