Pediatric Patient Experience on a Diagnostic Path

NCT05199363 | Unknown

• 1 other identifier: Nr510/2021_ChildrensMHIPoland
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Urinary Incontinence; Growth Deficiency; Visual Impairment; Psychomotor Retardation, Mild to Severe; Demyelinating Diseases; Brain Tumor

Keywords

child; magnetic resonance imaging; anxiety; patient experience

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year

Secondary Outcomes (1)

• State-Trait Anxiety Inventory

  through study completion, an average of 1 year

Other Outcomes (3)

• Patient's experience questionaire

  through study completion, an average of 1 year

• Patient's caregiver/parent experience questionaire

  through study completion, an average of 1 year

• Patient's and caregiver's co-operation during the MR examination questionaire

  through study completion, an average of 1 year

Study Arms (4)

Information leaflet

ACTIVE COMPARATOR

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?"

Other: Information leaflet

Educational movie

ACTIVE COMPARATOR

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?"

Other: Educational movie

Demonstration

ACTIVE COMPARATOR

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".

Other: Demonstration

Control

NO INTERVENTION

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

Interventions

Information leaflet OTHER

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?"

Information leaflet

Educational movie OTHER

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?"

Educational movie

Demonstration OTHER

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"

Demonstration

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead
• Siemens Healthcare Sp. z o.o.: collaborator

Study Sites (1)

Children Memorial Health Institute (CMHI)

Warsaw, 04-730, Poland

RECRUITING

Related Publications (5)

• 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.

  PMID: 26245604 BACKGROUND

• 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.

  PMID: 24118524 BACKGROUND

• 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.

  PMID: 31047258 BACKGROUND

• 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.

  PMID: 31047261 BACKGROUND

• 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.

  PMID: 27888940 BACKGROUND

MeSH Terms

Conditions

Headache; Urinary Incontinence; Vision Disorders; Psychomotor Disorders; Demyelinating Diseases; Brain Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Sensation Disorders; Nervous System Diseases; Eye Diseases; Neurobehavioral Manifestations; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Mental Disorders

Study Officials

• Elżbieta Jurkiewicz, MD, PhD

  CMHI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elżbieta Jurkiewicz, MD, PhD

CONTACT

+48 22 815 1276; e.jurkiewicz@ipczd.pl

Zbigniew Kułaga, MD, PhD

CONTACT

+48 603547517; z.kulaga@ipczd.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 20, 2022
• Study Start: October 15, 2021
• Primary Completion: October 15, 2022
• Study Completion: December 15, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)