PainNCT04772430
"The Effect of Snow Globe Used in Infancy Vaccination Applications on Pain Level."
A study testing snow globe in people with Pain, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to determine the effect of the snow globe, which is used as a method of diverting attention, to the perception of pain that develops during the application of vaccines in infants between 2-6 months of age. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- snow globe
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Apr 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 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being registered at Bartın Family Health Center
- Being in the age range of 2-6 months
- Having parental consent
- Does not have a congenital or chronic health problem,
- Not taking an analgesic drug in the last 4 hours,
- Infants of families who have accepted to participate in the study and signed the informed consent form will be included in the study
Who cannot join
- Being aged between 0-1 months and over 6 months,
- No parental consent,
- Using analgesics in the last 4 hours,
- The child has a congenital or chronic health problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Betül Akkoç
Merkez, Bartın, 74000
betül akkoç, +905061013330, betulakkoc89@hotmail.com
tülay ayyıldız kuzlu, +905326662631, tayyildiz67@hotmail.com
About this study
Official title: Zonguldak Bulent Ecevit University
The aim of this research is to determine the effect of the snow globe, which is used as a method of diverting attention, to the perception of pain that develops during the application of vaccines in infants between 2-6 months of age.
Read the detailed description
Atraumatic care philosophy developed by Donna Wong; it is a principle of therapeutic care aimed at minimizing or eliminating the physical and psychological problems experienced by the child and his/her family. Pediatric nurse; it is obliged to offer atraumatic care by ensuring the cooperation of the child and his/her family, reducing pain and controlling stressors.
In accordance with the principles of atraumatic care; limitation of painful initiatives to prevent or reduce physical stress sources, regulation of environmental conditions, use of pharmacological and nonpharmamological pain removal methods in the presence of pain; promoting family-centered care in order to ensure the unity of children and family members; informing the child and his family about care to ensure the development of a sense of control, resting recommendations on care, establishing a daily care program.
The American Pain Association considers pain the fifth life finding. Studies show that all babies, including preterm babies, suffer pain and can distinguish pain from other sensory experiences. Controlling pain in children is multidisciplinary team work. It makes the nurse different from other team members in the control of pain and ensures that she is in an indispensable position; the nurse spends a long time with children, learns about the child's previous pain experiences and methods of coping with pain and benefits from coping methods when necessary, teaching the child and his family strategies to cope with pain, guiding them, applying planned treatment, monitoring their effects, results and empathizing, in short, being able to practice the nursing process.
Children who are often subjected to painful invasive interventions from the newborn period; however, they have a structure that requires the consideration of their level of development, cognitive and communicative skills, previous experiences of pain. According to the American Academy of Pediatrics , newborns and children are exposed to a total of 24 injections due to vaccination in the first 2 years of their life. In Turkey, the total number of injections for routine vaccination of children up to 2 years of age is 18. The negative effects of pain, which cannot be managed effectively, in physiological and psychological dimensions can occur even years later. The pain and stress experienced with deterioration in the clinical condition of newborns brings many complications.
Pain in children is more difficult to assess than in adults. The perception of pain in children, age, gender, family reactions to pain, previous experiences, insomnia, fatigue, fear, sadness, anger, being in an unpleasant environment can affect.
Conditions caused by pain include short-term changes such as respiratory irregularity, hypoxemia, fading or redness, blood pressure changes, increased heart rate and oxygen consumption, enlargement of pupils, as well as permanent, structural and functional (endocrine, behavior and immune system) changes. It negatively affects the behavior, family infant interaction, diet and clinical course of babies who warn of long-term and frequent pain, as well as prevents the baby's adaptation to the outside world. Repeated painful interventions can lead to neurotoxia and lead to deterioration in social cohesion, anxiety, change in pain sensitivity, stress disorders, hyperactivity/attention deprivation in the future. That's why the American Pain Society (APS) and the American Academy Of Pediatrics (AAP) recommend minimizing pain and anxiety due to procedures. The high number of vaccines for children and infants and the psychological traumas caused by the pain caused by the vaccines make it mandatory to intervene in the pain that occurs during vaccination and are one of the ethical issues
Research shows that nurses do not make adequate pain assessments and do not use nonpharmamological methods effectively. Nonpharmaciological pain methods, which are effective in consequential or alone, can also be used in the elimination of pain, among the non-pharmacological methods such as hot cold application, diverting attention, listening to music, balloon blowing, reading books, watching movies, vibration, transcutaneous electrical nerve stimulation (transcutaneous electrical nerve stimulation) application.
Divert attention; it is a non-drug method that is often used in the management of pain in children. It removes the perception of pain by focusing the individual's attention away from pain and in another focus. More work is needed to improve pain management in children and illuminate optimal pain management and strategies that take into account children-specific needs
- Conditions
- Pain
- Being tested
- snow globe
- Keywords
- pain, immunization, diverting attention, infancy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
snow globeRadiation
Control group; The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure.
Experimental group; The baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure |
| Experimental group | Experimental | The baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure. Receives: Radiation: snow globe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale
Flacc pain scale score is obtained by evaluating in five categories as facial expression, leg movements, activity, crying and consolingness. By giving 0, 1, or 2 points for each category, the total score between 0 and 10 is reached. As the pain intensity increases, the total score increases, as the pain intensity decreases, the total score decreases
Measured: 2-6 months
Secondary outcomes (3)
Heart rate
heart rate of the babies were recorded using a pulse oximeter placed on the right or left foot or hand of each baby before the invention. heart rate levels were recorded during and after vaccination .
Measured: 2-6 months
oxygen saturation
oxygen saturation of the babies were recorded using a pulse oximeter placed on the right or left foot or hand of each baby before the intervention. oxygen saturation levels were recirded during anda after vaccination
Measured: 2-6 months
crying duration of babies
the crying time was expressed in seconds. The crying time is measured and recorded with the stopwatch before and after the procedure.
Measured: 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Aug 2020
- Primary completion1 Oct 2020
- Study completion1 Apr 2021 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Akkoc, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772430
- Sponsor's protocol ID
- 12102020100140
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zonguldak Bulent Ecevit University
- ClinicalTrials.gov ID
- NCT04772430
- Acronym / sponsor ID
- 12102020100140
- Conditions
- Pain
- Keywords
- pain, immunization, diverting attention, infancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 26 Feb 2021 (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.
The aim of this research is to determine the effect of the snow globe, which is used as a method of diverting attention, to the perception of pain that develops during the application of vaccines in infants between 2-6 months of age.
Detailed description
Atraumatic care philosophy developed by Donna Wong; it is a principle of therapeutic care aimed at minimizing or eliminating the physical and psychological problems experienced by the child and his/her family. Pediatric nurse; it is obliged to offer atraumatic care by ensuring the cooperation of the child and his/her family, reducing pain and controlling stressors.
In accordance with the principles of atraumatic care; limitation of painful initiatives to prevent or reduce physical stress sources, regulation of environmental conditions, use of pharmacological and nonpharmamological pain removal methods in the presence of pain; promoting family-centered care in order to ensure the unity of children and family members; informing the child and his family about care to ensure the development of a sense of control, resting recommendations on care, establishing a daily care program.
The American Pain Association considers pain the fifth life finding. Studies show that all babies, including preterm babies, suffer pain and can distinguish pain from other sensory experiences. Controlling pain in children is multidisciplinary team work. It makes the nurse different from other team members in the control of pain and ensures that she is in an indispensable position; the nurse spends a long time with children, learns about the child's previous pain experiences and methods of coping with pain and benefits from coping methods when necessary, teaching the child and his family strategies to cope with pain, guiding them, applying planned treatment, monitoring their effects, results and empathizing, in short, being able to practice the nursing process.
Children who are often subjected to painful invasive interventions from the newborn period; however, they have a structure that requires the consideration of their level of development, cognitive and communicative skills, previous experiences of pain. According to the American Academy of Pediatrics , newborns and children are exposed to a total of 24 injections due to vaccination in the first 2 years of their life. In Turkey, the total number of injections for routine vaccination of children up to 2 years of age is 18. The negative effects of pain, which cannot be managed effectively, in physiological and psychological dimensions can occur even years later. The pain and stress experienced with deterioration in the clinical condition of newborns brings many complications.
Pain in children is more difficult to assess than in adults. The perception of pain in children, age, gender, family reactions to pain, previous experiences, insomnia, fatigue, fear, sadness, anger, being in an unpleasant environment can affect.
Conditions caused by pain include short-term changes such as respiratory irregularity, hypoxemia, fading or redness, blood pressure changes, increased heart rate and oxygen consumption, enlargement of pupils, as well as permanent, structural and functional (endocrine, behavior and immune system) changes. It negatively affects the behavior, family infant interaction, diet and clinical course of babies who warn of long-term and frequent pain, as well as prevents the baby's adaptation to the outside world. Repeated painful interventions can lead to neurotoxia and lead to deterioration in social cohesion, anxiety, change in pain sensitivity, stress disorders, hyperactivity/attention deprivation in the future. That's why the American Pain Society (APS) and the American Academy Of Pediatrics (AAP) recommend minimizing pain and anxiety due to procedures. The high number of vaccines for children and infants and the psychological traumas caused by the pain caused by the vaccines make it mandatory to intervene in the pain that occurs during vaccination and are one of the ethical issues
Research shows that nurses do not make adequate pain assessments and do not use nonpharmamological methods effectively. Nonpharmaciological pain methods, which are effective in consequential or alone, can also be used in the elimination of pain, among the non-pharmacological methods such as hot cold application, diverting attention, listening to music, balloon blowing, reading books, watching movies, vibration, transcutaneous electrical nerve stimulation (transcutaneous electrical nerve stimulation) application.
Divert attention; it is a non-drug method that is often used in the management of pain in children. It removes the perception of pain by focusing the individual's attention away from pain and in another focus. More work is needed to improve pain management in children and illuminate optimal pain management and strategies that take into account children-specific needs
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure |
| Experimental group | Experimental | Radiation: snow globeThe baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being registered at Bartın Family Health Center
- Being in the age range of 2-6 months
- Having parental consent
- Does not have a congenital or chronic health problem,
- Not taking an analgesic drug in the last 4 hours,
Key exclusion criteria (4 listed)
- Being aged between 0-1 months and over 6 months,
- No parental consent,
- Using analgesics in the last 4 hours,
- The child has a congenital or chronic health problem
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 |
|---|---|---|
| snow globeControl group; The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure. Experimental group; The baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure. | Radiation | Experimental group |
Primary outcome
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale
Time frame: 2-6 months
Flacc pain scale score is obtained by evaluating in five categories as facial expression, leg movements, activity, crying and consolingness. By giving 0, 1, or 2 points for each category, the total score between 0 and 10 is reached. As the pain intensity increases, the total score increases, as the pain intensity decreases, the total score decreases
3 secondary outcomes
Heart rate
Time frame: 2-6 months
oxygen saturation
Time frame: 2-6 months
crying duration of babies
Time frame: 2-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing snow globe in people with Pain, run by Zonguldak Bulent Ecevit University 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale (time frame: 2-6 months). 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 26 Feb 2021.