Investigation of the Impact of Burn Injury on Parents | NCT03838172

Studies
Investigation of the Impact of Burn Injury on Parents

NCT03838172

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Aug 25, 2021Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Burns
Parents

Interventions

Family impact scale

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2019Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Feb 10, 2019

First Submission Date that Met QC Criteria

Feb 10, 2019

First Posted Date

Feb 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2021

Last Update Posted Date

Aug 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Burn injuries are related to longer hospital stay. Patients who have a burned child are affected prolonged hospitalization. Social life and quality of life are affected by burn injuries. Therefore, the aim of this study is to investigate the effects of burn injury on parents.

Detailed Description

Pediatric burn injuries is commonly seen. Burn injuries are extended from minor injuries to severe injuries. The severity of burn injury may affect burn related complications such as scar tissue and duration of hospitalization. This process extremely affect parents. Although parents are part of this prolonged treatments process, there is no study that evaluated of the impact of burn injury on parents. Therefore, the aim of this study is to investigate the effects of burn injury on parents.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parents		Parents who have a burned child	Other: Family impact scale

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Family impact scale	Other	The family Impact Scale (FIS) will be completed by the parents	Parents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Family of Impact scale	questionnaire is a self-report instrument designed to measure the effects of childhood diseased on parents. A low score indicates a higher impact of the disease on the parents.	15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Nottingham Health Profile	Nottingham Health Profile is a widely used measure of perceived health status. The higher score is indicated the lower quality of life.	15 minutes
The hospital anxiety and depression scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents who have a burned child
Parents who have a volunteer

Exclusion Criteria:

Parents who have no confirm to participate this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Parents who have a burned child

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ozden Ozkal		Ankara		06100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D002921	Cicatrix

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided