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Pediatric Patient Experience on a Diagnostic Path

Primary Purpose

Headache, Urinary Incontinence, Growth Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Information leaflet
Educational movie
Demonstration
Sponsored by
Children's Memorial Health Institute, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache focused on measuring child, magnetic resonance imaging, anxiety, patient experience

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 10-14 years.
  • Referred for magnetic resonance imaging due to clinical indications.
  • Patients undergoing magnetic resonance examination for the first time.
  • Possibility of cooperating with the patient during the examination, no need for sedation.
  • Consent of the patients' caregivers to participate in the examination; in the case of patients ≥ 13 years of age, also the patients' consents.
  • Absence of contraindications to magnetic resonance imaging

Exclusion Criteria:

  • Lack of parental or patient consent to participate in the trial.
  • Contraindications to undergo magnetic resonance imaging.
  • Lack of possibility to cooperate with the patient during the examination and/or the need for general anaesthesia for the MR examination.

Sites / Locations

  • Children Memorial Health Institute (CMHI)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Information leaflet

Educational movie

Demonstration

Control

Arm Description

Before examination study participant will obtain an information leaflet which includes descriptive and illustrative sections "Information for young patients and their caregivers. What is Magnetic Resonance Imaging and what is the examination like?"

Before examination study participant will be shown educational video with an radiology technologist and actors who role play the examination "What is MRI and what is the examination like?"

Before examination study participant will take a part in scenario-based demonstration with the use of props such as the scanner model and a multimedia presentation "Scenario for a demonstration before a Magnetic Resonance examination for young patients and their caregivers".

Study participant will obtain standard information about magnetic resonance imaging before examination.

Outcomes

Primary Outcome Measures

State-Trait Anxiety Inventory for Children
Change in State-Trait Anxiety Inventory for Children score; minimum score=20, maximum score=60, higher scores mean a worse outcome

Secondary Outcome Measures

State-Trait Anxiety Inventory
Change in parent's State-Trait Anxiety Inventory score; minimum score=20, maximum score=80, higher scores mean a worse outcome

Full Information

First Posted
December 28, 2021
Last Updated
January 19, 2022
Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Siemens Healthcare Sp. z o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT05199363
Brief Title
Pediatric Patient Experience on a Diagnostic Path
Official Title
Pediatric Patient Experience on a Diagnostic Path
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Siemens Healthcare Sp. z o.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The trial will determine the impact of an information- and education-focused interventions on the anxiety levels, and patients' experiences as well as satisfaction of patients aged 10-14 and their caregivers during the MR examination.
Detailed Description
The aims of the trial 1. Examining the level of anxiety of individuals undergoing magnetic resonance imaging (MRI) as patients or caregivers (anxiety is measured at two points: before and after the MRI procedure). 2. Examining subjective patients' and caregivers' assessments of the key factors which make up the Patient Experience, i.e. the sum of all interactions which influence perceptions of the patients and their caregivers. The Patient Experience in this sense includes what is perceived, understood and remembered by the patient and their relatives in terms of: access to services and resources coordination and safety effectiveness of the services communication and education patient empowerment respect and dignity ensuring physical wellbeing ensuring psychological wellbeing environment and comfort and consequent levels of satisfaction. The full set of factors will only be examined for the patients' caregivers, while for the patients themselves the set of factors will be limited to those which can be competently assessed by persons aged 10-14 years. 3. Examining the extent to which education- and information-focused interventions, using a variety of media (information leaflets, educational video, demonstration with props), impact anxiety levels, individual elements of the experience, and patients' and caregivers' satisfaction levels. 4. Examining the extent to which educational- and informational-focused interventions can increase patients' co-operation and thus contribute to shorter examination times (avoidance of repetition of sequences) and a reduction in the rate of interrupted examinations. The participants will be recruited by the registration staff of the Magnetic Resonance (MR) Laboratory from those enrolled for magnetic resonance examinations for clinical indications. It will be done during a routine reminder of the upcoming examination date. The staff member informs the patient's caregiver of a possibility to participate in the examination and, after obtaining a preliminary declaration of participation, of the necessity to arrive 1 hour before the predetermined time. When the patient and their caregiver arrive at the Registration of the Magnetic Resonance Laboratory, a registration staff member hands over the "Information on the Trial regarding the Paediatric Patient Experience on the Diagnostic Pathway" which contains details of the objectives, design, scope and duration of the procedures and inconvenience of the trial which will be conducted, the expected benefits to participants of the trial which is a research experiment, and the health risks and hazards for the participants, the arrangements regarding handling any adverse events, the measures undertaken to ensure respect for the participants' privacy and the confidentiality of their personal data, and the rules for access to relevant information concerning the participants obtained during implementation of the experiment and the overall results thereof and for further use of the results thereof. The investigator also informs the participants of the possibility of withdrawing from the trial at any stage, of the rules on compensation in the event of any harm and of the source of funding of the medical experiment. After answering any questions from the subject, the investigator collects a signed Informed Consent Form from both the caregiver and the child, together with the information about the trial attached to it. A staff member of the Registration of the Magnetic Resonance Laboratory draws an allocation to one of the Groups (A/B/C/D) from a pool of sealed envelopes together with a unique code for the trial and enters the code into all questionnaires used in the trial. An radiology technologist or psychologist (after receiving training in the objectives, protocol and tools of the trial) provides the interventions as they are appropriate to groups: to Group A: the investigator gives the information leaflet "Information for young patients and their caregivers. What is MRI and what is the examination like?" and ensures that the patient and caregiver read it. to Group B: the investigator plays the educational video "What is an MRI and what is the examination like?" to the patient and caregiver and ensures that the patient and caregiver familiarise themselves with it. to Group C: the investigator conducts a scenario-based demonstration using props in the form of a model scanner and a multimedia presentation ("Scenario for demonstration before a magnetic resonance examination for young patients and their caregivers")." No intervention is carried out in Group D. The patient's caregiver completes the State-Trait Anxiety Inventory (STAI) questionnaire. The patient (assisted by a technician or psychologist) completes the State-Trait Anxiety Inventory for Children (STAIC) form. A standard process of preparing for the magnetic resonance examination by a technician follows, and the magnetic resonance examination is performed as clinically indicated. The technician completes the questionnaire entitled "Assessment of the patient's and their caregiver's cooperation during magnetic resonance examination". The caregiver again completes the State-Trait Anxiety Inventory (STAI) questionnaire. The patient's caregiver completes the questionnaire "Assessment of the experience of the patient's caregiver during magnetic resonance examination". The patient (assisted by a technician or psychologist) again fills in the "State-Trait Anxiety Inventory for Children (STAIC) questionnaire. The patient (assisted by a technician or psychologist) fills in the questionnaire "Evaluation of the patient's experience during the magnetic resonance examination".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Urinary Incontinence, Growth Deficiency, Visual Impairment, Psychomotor Retardation, Mild to Severe, Demyelinating Diseases, Brain Tumor
Keywords
child, magnetic resonance imaging, anxiety, patient experience

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomly assigned into one of 4 groups: Group A, 25% of the sample - patients subject to intervention No 1: "Information leaflet" Group B, 25% of the sample - patients subject to intervention No. 2: "Educational movie" Group C, 25% of the sample - patients subject to intervention No. 3 "Demonstration" Group D, 25% of the sample - control group, with no intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Information leaflet
Arm Type
Active Comparator
Arm Description
Before examination study participant will obtain an information leaflet which includes descriptive and illustrative sections "Information for young patients and their caregivers. What is Magnetic Resonance Imaging and what is the examination like?"
Arm Title
Educational movie
Arm Type
Active Comparator
Arm Description
Before examination study participant will be shown educational video with an radiology technologist and actors who role play the examination "What is MRI and what is the examination like?"
Arm Title
Demonstration
Arm Type
Active Comparator
Arm Description
Before examination study participant will take a part in scenario-based demonstration with the use of props such as the scanner model and a multimedia presentation "Scenario for a demonstration before a Magnetic Resonance examination for young patients and their caregivers".
Arm Title
Control
Arm Type
No Intervention
Arm Description
Study participant will obtain standard information about magnetic resonance imaging before examination.
Intervention Type
Other
Intervention Name(s)
Information leaflet
Intervention Description
Before examination study participant will obtain an information leaflet which includes descriptive and illustrative sections "Information for young patients and their caregivers. What is Magnetic Resonance Imaging and what is the examination like?"
Intervention Type
Other
Intervention Name(s)
Educational movie
Intervention Description
Before examination study participant will be shown educational video with an radiology technologist and actors who role play the examination "What is MRI and what is the examination like?"
Intervention Type
Other
Intervention Name(s)
Demonstration
Intervention Description
Before examination study participant will take a part in scenario-based demonstration with the use of props such as the scanner model and a multimedia presentation "Scenario for a demonstration before a Magnetic Resonance examination for young patients and their caregivers"
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory for Children
Description
Change in State-Trait Anxiety Inventory for Children score; minimum score=20, maximum score=60, higher scores mean a worse outcome
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory
Description
Change in parent's State-Trait Anxiety Inventory score; minimum score=20, maximum score=80, higher scores mean a worse outcome
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Patient's experience questionaire
Description
Questionaire which assesses patient's experience during Magnetic Resonance examination; minimum score=0, maximum score=10, higher scores mean a better outcome
Time Frame
through study completion, an average of 1 year
Title
Patient's caregiver/parent experience questionaire
Description
Questionaire which assesses patient's caregiver experience during MR examination; minimum score=0, maximum score=10, higher scores mean a better outcome
Time Frame
through study completion, an average of 1 year
Title
Patient's and caregiver's co-operation during the MR examination questionaire
Description
Questionnaire which assesses the level of co-operation with the patient and their caregiver; minimum score=0, maximum score=10, higher scores mean a better outcome; as well as the occurrence of certain phenomena such as the need for additional sequences or the need to interrupt the examination: no / yes, yes is a worse outcome (to be completed by the technician)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 10-14 years. Referred for magnetic resonance imaging due to clinical indications. Patients undergoing magnetic resonance examination for the first time. Possibility of cooperating with the patient during the examination, no need for sedation. Consent of the patients' caregivers to participate in the examination; in the case of patients ≥ 13 years of age, also the patients' consents. Absence of contraindications to magnetic resonance imaging Exclusion Criteria: Lack of parental or patient consent to participate in the trial. Contraindications to undergo magnetic resonance imaging. Lack of possibility to cooperate with the patient during the examination and/or the need for general anaesthesia for the MR examination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elżbieta Jurkiewicz, MD, PhD
Phone
+48 22 815 1276
Email
e.jurkiewicz@ipczd.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Zbigniew Kułaga, MD, PhD
Phone
+48 603547517
Email
z.kulaga@ipczd.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elżbieta Jurkiewicz, MD, PhD
Organizational Affiliation
CMHI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children Memorial Health Institute (CMHI)
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elżbieta Jurkiewicz, MD, PhD
Phone
+48 22 815 1276
Email
e.jurkiewicz@ipczd.pl
First Name & Middle Initial & Last Name & Degree
Zbigniew Kułaga, MD, PhD
Phone
603547517
Email
z.kulaga@ipczd.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26245604
Citation
Makanjee CR, Bergh AM, Hoffmann WA. Healthcare provider and patient perspectives on diagnostic imaging investigations. Afr J Prim Health Care Fam Med. 2015 May 20;7(1):801. doi: 10.4102/phcfm.v7i1.801.
Results Reference
background
PubMed Identifier
24118524
Citation
Carlsson S, Carlsson E. 'The situation and the uncertainty about the coming result scared me but interaction with the radiographers helped me through': a qualitative study on patients' experiences of magnetic resonance imaging examinations. J Clin Nurs. 2013 Nov;22(21-22):3225-34. doi: 10.1111/jocn.12416.
Results Reference
background
PubMed Identifier
31047258
Citation
Munn Z, Pearson A, Jordan Z, Murphy F, Pilkington D, Anderson A. Addressing the Patient Experience in a Magnetic Resonance Imaging Department: Final Results from an Action Research Study. J Med Imaging Radiat Sci. 2016 Dec;47(4):329-336. doi: 10.1016/j.jmir.2016.04.007. Epub 2016 Jun 27.
Results Reference
background
PubMed Identifier
31047261
Citation
Bolderston A. Patient Experience in Medical Imaging and Radiation Therapy. J Med Imaging Radiat Sci. 2016 Dec;47(4):356-361. doi: 10.1016/j.jmir.2016.09.002. Epub 2016 Oct 15.
Results Reference
background
PubMed Identifier
27888940
Citation
Jensen JD, Allen L, Blasko R, Nagy P. Using Quality Improvement Methods to Improve Patient Experience. J Am Coll Radiol. 2016 Dec;13(12 Pt B):1550-1554. doi: 10.1016/j.jacr.2016.09.005.
Results Reference
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Pediatric Patient Experience on a Diagnostic Path

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