PainNCT05288309
The Effect Of Use Of Raınstick And Kaleydoscope On Paın Anxıety Durıng Blood Draw
A study testing RAINSTİCK and KALEİDOSCOPE in people with Pain and Child, Only, run by Erzincan Binali Yildirim Universitesi at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Child, Only, Anxiety
- What is being tested?
- RAINSTİCK and KALEİDOSCOPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- The transmission barrier
- Wearing glasses
- Involuntary
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Erzincan Binali Yıldırım University
Center, Erzi̇ncan, 24000
Erzincan Binali Yıldırım Üniversitesi
Center, Erzi̇ncan, 24000
About this study
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
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.
Read the 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.
- Conditions
- Pain, Child, Only, Anxiety, Pain, Procedural
- Being tested
- RAINSTİCK, KALEİDOSCOPE
- Keywords
- Anxiety, Blood draw, children, Nursing, Pain, Rainstick, Kaleidoscope
- Medical subject headings
- Pain, Anxiety Disorders, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAINSTİCKOther
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.
KALEİDOSCOPEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RAİNSTİCK | Other | In the 1st experimental group, the sound of the rain stick was played to distract attention. The rainstick, used by traditional societies, is a rhythm instrument that makes the sound of rain by moving it up and down. The length of the rain stick made of bamboo is 40 cm. There are spiral-shaped spines inside the tool, which is closed at both ends. It makes the sound of drizzling rain by moving it up and down. Receives: Other: RAINSTİCK |
| KALEİDOSCOPE | Other | In the second experimental group, kaleidoscope was used to distract attention. A kaleidoscope, or kaleidoscope, is a device that sees colorful patterns when looked into. Inside, there are three mirrors adjacent to each other with an inclination of 60 degrees between them. There are pieces of colored glass between the mirrors. When viewed from one end of this binocular, shape-shifting polygons are seen, often with images that will never be the same again. These patterns are created by the reflection of light and change constantly as the binoculars are moved. Receives: Other: KALEİDOSCOPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Wong-Baker Faces Pain Scale Mean Scores by Groups
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.
Measured: It will be evaluated within an average of 5 minutes during the blood collection process.
Secondary outcomes (1)
Comparison of Child Anxiety Scale Mean Scores before and during the procedure according to the groups
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsün Ayran, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288309
- Sponsor's protocol ID
- Erzi̇ncanBYÜ
- Status last verified
- Oct 2022
- First submitted
- 3 Feb 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05288309
- Acronym / sponsor ID
- Erzi̇ncanBYÜ
- Conditions
- Pain, Child, Only, Anxiety, Pain, Procedural
- Keywords
- Anxiety, Blood draw, children, Nursing, Pain, Rainstick, Kaleidoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAİNSTİCK | Other | Other: RAINSTİCKIn the 1st experimental group, the sound of the rain stick was played to distract attention. The rainstick, used by traditional societies, is a rhythm instrument that makes the sound of rain by moving it up and down. The length of the rain stick made of bamboo is 40 cm. There are spiral-shaped spines inside the tool, which is closed at both ends. It makes the sound of drizzling rain by moving it up and down. |
| KALEİDOSCOPE | Other | Other: KALEİDOSCOPEIn the second experimental group, kaleidoscope was used to distract attention. A kaleidoscope, or kaleidoscope, is a device that sees colorful patterns when looked into. Inside, there are three mirrors adjacent to each other with an inclination of 60 degrees between them. There are pieces of colored glass between the mirrors. When viewed from one end of this binocular, shape-shifting polygons are seen, often with images that will never be the same again. These patterns are created by the reflection of light and change constantly as the binoculars are moved. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- The transmission barrier
- Wearing glasses
- Involuntary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAINSTİCKWhen 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. | Other | RAİNSTİCK |
| KALEİDOSCOPEThe 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. | Other | KALEİDOSCOPE |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAINSTİCK and KALEİDOSCOPE in people with Pain and Child, Only, run by Erzincan Binali Yildirim Universitesi at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.