| CTRI Number |
CTRI/2024/12/078439 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Learning About Patients Experiences and Opinions on MRI Scans in a Hospital. |
|
Scientific Title of Study
|
Patients’ Knowledge, Perception, and Experience during Magnetic Resonance Imaging in Radiology Services at a Tertiary Care Teaching Hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun K V |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7012137084 |
| Fax |
|
| Email |
arun.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi K S |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9481749911 |
| Fax |
|
| Email |
swathi.ks@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Swathi K S |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104
KARNATAKA
576104
India |
| Phone |
9481749911 |
| Fax |
|
| Email |
swathi.ks@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis and Imaging, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 |
| Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Arun K V |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swathi K S |
Kasturba Hospital |
Department of Radiodiagnosis and Imaging, Kasturba Hospital, Manipal, Udupi, Karnataka, India, 576104
Udupi
KARNATAKA |
9481749911
swathi.ks@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants who can understand and communicate in the local language(s) (Kannada)or common languages used in the hospital (English). Participants who are willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Participants who are unable to participate in the study due to severe physical, cognitive, or mental impairments. Participants who have undergone emergency or urgent MRI scans, as their experiences may differ from those of patients undergoing elective scans. Participants who have previously participated in the study or have declined to participate. Participants who have not undergone a complete MRI scan (e.g., due to technical issues or early termination of the procedure) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to assess patients knowledge perception and experience during the MRI procedure |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to identify the perceptions & factors influencing patients during the MRI procedure |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="423"
Sample Size from India="423"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim The aim of this study is to assess the knowledge, perception, and experience of patients during Magnetic Resonance Imaging (MRI) examinations in the radiology services of a tertiary care teaching hospital.
Objectives 1. To evaluate the level of knowledge that patients have about the purpose, process, and potential risks/side effects of the Magnetic Resonance Imaging (MRI) procedure. 2. To assess patients’ perceptions of the MRI examination, including their level of comfort, anxiety, and overall satisfaction with the experience.
Materials A Pre-validated questionnaire will be used in this study.
Methods A cross-sectional prospective survey was conducted in the radiology department. Patients who have undergone MRI during the specified period. Simple Random Sampling with a target sample size of at least 422 patients. A pre-validated questionnaire assessing patient’s knowledge, perception, and experience during MRI. Covers demographic and clinical characteristics, knowledge about MRI, perceptions, and experience factors.
Tools used Pre-validated questionnaires
Detailed description of procedure/processes: Necessary permissions and clearances from the Institutional Ethics Committee (IEC) will be obtained. Participants will be recruited using simple random sampling. As it’s a cross-sectional study, the data will be collected from the patients who visit the Radiology department. After collecting the individual patient’s data, the parameters’ assessment and relationship will be analysed. The simple flow chart below explains the detailed procedure: Initial screening of the Inpatients and outpatients in the Radiology departments and selection of the cases based on the inclusion and exclusion criteria. Informed consent will be obtained from the patients. Patient data will be collected. Analysis of Patients’ Knowledge, Perception and Experience during Magnetic Resonance Imaging. The relationships between Patients’ Knowledge, Perception, and Experience during Magnetic Resonance Imaging. Results and Conclusion |