Nurse's RoleNCT06172972
Atraumatic Care Practice From the Child and Parent Perspective
A study testing Atraumatic nursing care in people with Nurse's Role, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
It is important for pediatric nurses to apply atraumatic care while providing care to children and their families. Pediatric nurses should use methods appropriate for the child's age and developmental period within the scope of atraumatic care. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Atraumatic nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being able to speak Turkish
- being between 5-10 years of age
- having no visual, intellectual or neurological disabilities
- having the phlebotomy procedure carried out with a single attempt
- not having a disease that causes chronic pain
- being accompanied by either mother or father during the procedure
- not taking painkillers or sedating drugs before the phlebotomy procedure
Who cannot join
- being younger than 5 years or older than 10 years
- having visual, audio, or speech impairments
- having a disease that causes chronic pain
- with a history of sedative and analgesic use within 24 h prior to admission
- filling out the data collection forms incompletely
Trial locations and contacts
1 site in 1 country.
About this study
It is important for pediatric nurses to apply atraumatic care while providing care to children and their families. Pediatric nurses should use methods appropriate for the child's age and developmental period within the scope of atraumatic care.
Read the detailed description
The use of atraumatic care approaches such as supporting the active participation of the family in the care of the child, using therapeutic communication techniques with parents and children during procedures, providing emotional support, reducing pain during painful procedures, using techniques to distract the child's attention during medical procedures, informing parents about the procedures to be performed on their children, and supporting parents and teaching techniques to cope with stress is recommended to be used by the nurses.
- Conditions
- Nurse's Role
- Being tested
- Atraumatic nursing care
- Keywords
- child, fear, pain, phlebotomy, distraction methods, atraumatic care
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic nursing careBehavioural
Children in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic nursing care group | Experimental | Before the phlebotomy, children in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure. It was ensured that the parent was staying with the child and that the child played with this material during the procedure (making a foam balloon, squeezing the ball with the hand in which the procedure was not carried out and reading the book with the parent Receives: Behavioral: Atraumatic nursing care |
| Control group | No intervention | The parents of the children in the control group were ensured to stay with their children during the procedure, and the child's attention was distracted by the nurse asking questions about the child's name, age, and what grade the child was in. This is one of the methods frequently used in Turkiye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear Scale
Children's Fear Scale was to measure fear in children who would undergo painful medical procedures
Measured: baseline, pre-intervention and immediately after the intervention
Wong-Baker Faces Pain Rating Scale
This scale is used for 3-18 age group children to describe their pain.
Measured: immediately after the intervention
Secondary outcomes (1)
Assessment of Parental Satisfaction-Visual Analog Scale
Parent satisfaction scores were collected using a question about care satisfaction during the phlebotomy procedure from each child's parent.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Mar 2023
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Uzşen, Ondokuz Mayıs University
- Investigators
- Esra Tural Büyük, PhD, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172972
- Sponsor's protocol ID
- Atraumatic Care
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atraumatic Care Practice From the Child and Parent Perspective
- ClinicalTrials.gov ID
- NCT06172972
- Acronym / sponsor ID
- Atraumatic Care
- Conditions
- Nurse's Role
- Keywords
- child, fear, pain, phlebotomy, distraction methods, atraumatic care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Dec 2023 (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.
It is important for pediatric nurses to apply atraumatic care while providing care to children and their families. Pediatric nurses should use methods appropriate for the child's age and developmental period within the scope of atraumatic care.
Detailed description
The use of atraumatic care approaches such as supporting the active participation of the family in the care of the child, using therapeutic communication techniques with parents and children during procedures, providing emotional support, reducing pain during painful procedures, using techniques to distract the child's attention during medical procedures, informing parents about the procedures to be performed on their children, and supporting parents and teaching techniques to cope with stress is recommended to be used by the nurses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Atraumatic nursing care group | Experimental | Behavioral: Atraumatic nursing careBefore the phlebotomy, children in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure. It was ensured that the parent was staying with the child and that the child played with this material during the procedure (making a foam balloon, squeezing the ball with the hand in which the procedure was not carried out and reading the book with the parent |
| Control group | No intervention | –The parents of the children in the control group were ensured to stay with their children during the procedure, and the child's attention was distracted by the nurse asking questions about the child's name, age, and what grade the child was in. This is one of the methods frequently used in Turkiye. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- being able to speak Turkish
- being between 5-10 years of age
- having no visual, intellectual or neurological disabilities
- having the phlebotomy procedure carried out with a single attempt
- not having a disease that causes chronic pain
Key exclusion criteria (5 listed)
- being younger than 5 years or older than 10 years
- having visual, audio, or speech impairments
- having a disease that causes chronic pain
- with a history of sedative and analgesic use within 24 h prior to admission
- filling out the data collection forms incompletely
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 |
|---|---|---|
| Atraumatic nursing careChildren in the intervention group were allowed to choose a distracting method (foam balloons, stress balls, musical books) to be occupied with during the procedure | Behavioural | Atraumatic nursing care group |
Primary outcome
Children's Fear Scale
Time frame: baseline, pre-intervention and immediately after the intervention
Children's Fear Scale was to measure fear in children who would undergo painful medical procedures
Wong-Baker Faces Pain Rating Scale
Time frame: immediately after the intervention
This scale is used for 3-18 age group children to describe their pain.
1 secondary outcome
Assessment of Parental Satisfaction-Visual Analog Scale
Time frame: immediately after the intervention
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 15 Dec 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Nurse's Role
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Advancing Nursing Practices in Hospital Oncology Care
Gastrointestinal Cancer, Gastrointestinal Disease
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruitingObservational study
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
Experiences, Lived Experiences
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.
Esra Tural Büyük, PhD study chair
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic nursing care in people with Nurse's Role, run by Ondokuz Mayıs 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 7 inclusion and 5 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 15 Dec 2023. 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?
Children's Fear Scale (time frame: baseline, pre-intervention and immediately after the intervention). 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 15 Dec 2023.