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NCT Number: NCT05288309

The Effect Of Use Of Raınstick And Kaleydoscope On Paın Anxıety Durıng Blood Draw

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Child, Only Mental Disorders Neurologic Manifestations Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Binali Yıldırım University, Center, Erzi̇ncan, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAINSTİCK

Other

When the child, who was taken to Experimental Group 1, sat on the patient's chair, the sound of the rain stick was started to be played 1 minute before the blood draw. At that time, the nurse began 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 were performed by the nurse. Blood collection was taken from the antecubital region in one go by the same nurse by means of a vacuum blood collection tube, and blood flowed to the vacuum within 5 seconds, showing that the procedure was successful. This process took about 2-3 minutes and the children listened to the sound of rain sticks throughout the process.

KALEİDOSCOPE

Other

The child, who was taken into Experimental Group 2, was started to watch the kaleidoscope 1 minute before the blood draw, as he sat on the patient's chair. At that time, the nurse began 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 were performed by the nurse. Blood collection was taken from the antecubital region in one go by the same nurse by means of a vacuum blood collection tube, and blood flow to the vacuum within 5 seconds showed that the procedure was successful. This process took about 2-3 minutes and children were watched with kaleidoscope throughout the process.

Primary outcomes

  1. Comparison of Wong-Baker Faces Pain Scale Mean Scores by Groups

    Time frame: It will be evaluated within an average of 5 minutes during the blood collection process.

    This scale measuring the severity of pain was used in children aged between 3-18 years. In this scale, pain was scored for facial expressions according to numerical values, and the numerical rating of the scale varied between 0 and 10. Facial expressions ranging from smiling (0=very happy/no pain) to crying (10=most painful) indicated emotions.

Secondary outcomes

  1. Comparison of Child Anxiety Scale Mean Scores before and during the procedure according to the groups

    Time frame: 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.

    CSAS was a thermometer-like scale with a light bulb at the bottom and horizontal upward lines at intervals. On the scale, the children were instructed as "Imagine all your anxious or frustrated feelings are in the bulb or bottom of the thermometer." "If you're a little worried or nervous, emotions can go a little upward on the thermometer. If you are very, very anxious or nervous, the emotions can go to the top. Put a line indicating how worried or angry you are on the thermometer." A transparent meter with increments of ½ point marked was placed above the rating of children, then the increment of ½ point was rounded to the nearest number. The score varied between 0 and 10

Sponsors and collaborators

Lead sponsor

Erzincan Binali Yildirim Universitesi

Other

Registry information

Official study title

The Effect Of Use Of Raınstick And Kaleydoscope On Paın Anxıety And Parent Satısfactıon Durıng Blood Draw In Chıldren: A Randomızed Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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