Nurse's RoleNCT04631094
The Effect of Two Different Structured Balls on Pain and Fear Levels During Venous Blood Collection in Children
A study testing The group holding the serrated ball in the hand on the extremity from which venous blood will be taken, The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. and The group holding a smooth ball in the hand on the extremity from which venous blood will be taken in people with Nurse's Role, run by Zeynep Yurdakul at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- The group holding the serrated ball in the hand on the extremity from which venous blood will be taken, The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. and The group holding a smooth ball in the hand on the extremity from which venous blood will be taken
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 30 Jun 2021
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- - 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,
Show all 13Show fewer
- 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.
Who cannot join
- - 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse, PhD Student, Responsible Researcher
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.
Read the 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.
- Conditions
- Nurse's Role
- Being tested
- The group holding the serrated ball in the hand on the extremity from which venous blood will be taken, The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken., The group holding a smooth ball in the hand on the extremity from which venous blood will be taken, The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.
- Keywords
- child, fear, nursing, pain, venipuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group holding the serrated ball in the hand on the extremity from which venous blood will be takenOther
Also called serrated ball
Children in the experimental groups will squeeze the serrated ball during the blood draw.
The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken.Other
Also called serrated ball
Children in the experimental groups will squeeze the serrated ball during the blood draw.
The group holding a smooth ball in the hand on the extremity from which venous blood will be takenOther
Also called smooth ball
Children in the experimental groups will squeeze the smooth ball during the blood draw.
The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.Other
Also called smooth ball
Children in the experimental groups will squeeze the smooth ball during the blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The group holding the serrated ball in the hand on the extremity from which venous blood will be taken Receives: Other: The group holding the serrated ball in the hand on the extremity from which venous blood will be taken |
| Group 2 | Experimental | The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. Receives: Other: The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. |
| Group 3 | Experimental | The group holding a smooth ball in the hand on the extremity from which venous blood will be taken Receives: Other: The group holding a smooth ball in the hand on the extremity from which venous blood will be taken |
| Group 4 | Experimental | The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken. Receives: Other: The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken. |
| Group 5 | No intervention | The group that will undergo standard hospital blood collection procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level as assessed with Wong-Baker Faces Pain Rating Scale
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.
Measured: during the procedure
Fear as assessed using the Child Fear Scale
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.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start4 Jan 2021
- Primary completion18 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Yurdakul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Yurdakul, Ankara University
- Investigators
- Figen Işık ESENAY, Study director, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631094
- Sponsor's protocol ID
- Pediatric Nursing
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2020
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The child is between the ages of 6-12, * Volunteering of the child and parent to participate in the research, * Acceptance of wearing the transparent mask provided by the researcher, which clearly shows the facial expression, throughout the procedure, * Turkish speaking of the child and the parent, * The child does not have an auditory, mental or neurological disability that will affect his participation in the research, * Absence of problems related to skin integrity on the hand, * There is no obstacle to the grasp of the balls, * Not taking analgesic (systemic or topical), antipyretic, anti-inflammatory drugs in the last 12 hours, * Body temperature between 36.5-37.2 ⁰C, * Absence of acute pain before the procedure, * Absence of a disease that may cause chronic pain, * No regular invasive intervention (no chronic disease requiring blood control such as cancer, diabetes).
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse, PhD Student, Responsible Researcher
- ClinicalTrials.gov ID
- NCT04631094
- Acronym / sponsor ID
- Pediatric Nursing
- Conditions
- Nurse's Role
- Keywords
- child, fear, nursing, pain, venipuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Zeynep YurdakulUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Nov 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: The group holding the serrated ball in the hand on the extremity from which venous blood will be takenThe group holding the serrated ball in the hand on the extremity from which venous blood will be taken |
| Group 2 | Experimental | Other: The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken.The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. |
| Group 3 | Experimental | Other: The group holding a smooth ball in the hand on the extremity from which venous blood will be takenThe group holding a smooth ball in the hand on the extremity from which venous blood will be taken |
| Group 4 | Experimental | Other: The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken. |
| Group 5 | No intervention | –The group that will undergo standard hospital blood collection procedure. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- - 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,
Key exclusion criteria (13 listed)
- - 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,
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 |
|---|---|---|
| The group holding the serrated ball in the hand on the extremity from which venous blood will be takenAlso: serrated ballChildren in the experimental groups will squeeze the serrated ball during the blood draw. | Other | Group 1 |
| The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken.Also: serrated ballChildren in the experimental groups will squeeze the serrated ball during the blood draw. | Other | Group 2 |
| The group holding a smooth ball in the hand on the extremity from which venous blood will be takenAlso: smooth ballChildren in the experimental groups will squeeze the smooth ball during the blood draw. | Other | Group 3 |
| The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.Also: smooth ballChildren in the experimental groups will squeeze the smooth ball during the blood draw. | Other | Group 4 |
Primary outcome
Pain level as assessed with Wong-Baker Faces Pain Rating Scale
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.
Fear as assessed using the Child Fear Scale
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.
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 7 Mar 2025.
- Individual participant dataSharing planned: Yes. The child is between the ages of 6-12, * Volunteering of the child and parent to participate in the research, * Acceptance of wearing the transparent mask provided by the researcher, which clearly shows the facial expression, throughout the procedure, * Turkish speaking of the child and the parent, * The child does not have an auditory, mental or neurological disability that will affect his participation in the research, * Absence of problems related to skin integrity on the hand, * There is no obstacle to the grasp of the balls, * Not taking analgesic (systemic or topical), antipyretic, anti-inflammatory drugs in the last 12 hours, * Body temperature between 36.5-37.2 ⁰C, * Absence of acute pain before the procedure, * Absence of a disease that may cause chronic pain, * No regular invasive intervention (no chronic disease requiring blood control such as cancer, diabetes).
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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.
Figen Işık ESENAY study director
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group holding the serrated ball in the hand on the extremity from which venous blood will be taken, The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken. and The group holding a smooth ball in the hand on the extremity from which venous blood will be taken in people with Nurse's Role, run by Zeynep Yurdakul at 1 site 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 13 inclusion and 13 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pain level as assessed with Wong-Baker Faces Pain Rating Scale (time frame: during the procedure). The study lists 2 primary outcomes in all. 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 7 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.