Family Centered CareNCT04378673
The Effect of Parental Presence on Pain and Anxiety Levels During Peripheral Intravenous Catheterization in Infants
An observational study of Family Centered Care, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. Read more about this study
- Who is it for?
- Ages 2 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Family Centered Care
- What is being tested?
- not interventional
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 31 Aug 2020
- Phase
- Observational
- 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 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants and their parents were randomly sampled from the universe using a simple random sampling method, peripheral intravenous catheterization, volunteering to participate in the study, infants and parents between 1 and 24 months.
Who may be able to join
- Children within the age group of 1-24 months Parents know Turkish language
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training And Research Hospital
Istanbul, 34000
About this study
Official title: Pediatric Nursing in Bagcilar Training and Research Hospital
Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. It is extremely important that parents are with their children during painful procedures. Research; parents during peripheral intravenous catheterization in infancy It was planned to determine the effect of inclusion on pain and anxiety.
Read the detailed description
This randomized controlled trial included data from 120 cases in the Pediatric Health and Diseases Department of Istanbul, during March 2020-August 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). Information form, State-Trait Anxiety Inventory and FLACC scale were used to collect data.
- Conditions
- Family Centered Care
- Being tested
- not interventional
- Keywords
- family centered care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not interventionalOther
This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.
| Study group | Role | What they receive |
|---|---|---|
| parental involvement group | n=46 | |
| parental presence group | n=42 | |
| parental absence group | control group, n=32 Receives: Other: not interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypothesis 0
There is no difference between the pain and anxiety levels of the children whose parents were included in the procedure during peripheral intravenous catheterization and the pain and anxiety levels of the children whose parents were only with the child during the procedure and who were not with the child during the procedure.
Measured: March 2020-August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2020
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Centered CareStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nilüfer Demir, Nurse, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378673
- Sponsor's protocol ID
- 16867222
- Other IDs
- Seda Caglar
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Nursing in Bagcilar Training and Research Hospital
- ClinicalTrials.gov ID
- NCT04378673
- Acronym / sponsor ID
- 16867222
- Conditions
- Family Centered Care
- Keywords
- family centered care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 7 May 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.
Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. It is extremely important that parents are with their children during painful procedures. Research; parents during peripheral intravenous catheterization in infancy It was planned to determine the effect of inclusion on pain and anxiety.
Detailed description
This randomized controlled trial included data from 120 cases in the Pediatric Health and Diseases Department of Istanbul, during March 2020-August 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). Information form, State-Trait Anxiety Inventory and FLACC scale were used to collect data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| parental involvement group | – | –n=46 |
| parental presence group | – | –n=42 |
| parental absence group | – | Other: not interventionalcontrol group, n=32 |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants and their parents were randomly sampled from the universe using a simple random sampling method, peripheral intravenous catheterization, volunteering to participate in the study, infants and parents between 1 and 24 months.
Key inclusion criteria (1 listed)
- Children within the age group of 1-24 months Parents know Turkish language
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| not interventionalThis randomized controlled trial included data from 120 cases in the pediatric health and diseases department. | Other | parental absence group |
Primary outcome
hypothesis 0
Time frame: March 2020-August 2020
There is no difference between the pain and anxiety levels of the children whose parents were included in the procedure during peripheral intravenous catheterization and the pain and anxiety levels of the children whose parents were only with the child during the procedure and who were not with the child during the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Nilüfer Demir, Nurse principal investigator
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Centered Care, run by Bagcilar Training and Research Hospital 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 1 inclusion and 1 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 7 May 2020. 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?
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?
hypothesis 0 (time frame: March 2020-August 2020). 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 May 2020.