| CTRI Number |
CTRI/2024/05/068069 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Other (Specify) [MRI noise simulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MRI noise simulation effect on anxiety , co-operation and satisfaction among patients . undergoing neuro imaging |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of MRI noise simulation on anxiety , co-operation and satisfaction among patients undergoing neuro imaging at AIIMS Delhi |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anisha shreya |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS Delhi |
| Address |
College of nursing ,AIIMS Delhi ,Sri Aurobindo Marg, Ansari Nagar east ,New Delhi, Delhi 110029
Central
DELHI
110029
India |
| Phone |
6204767249 |
| Fax |
|
| Email |
anishashreya268@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Prashant Sinha |
| Designation |
associate professor |
| Affiliation |
AIIMS Delhi |
| Address |
College of nursing ,AIIMS Delhi ,Sri Aurobindo Marg, Ansari Nagar east ,New Delhi, Delhi 110029
Central
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anisha shreya |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS Delhi |
| Address |
College of nursing ,AIIMS Delhi ,Sri Aurobindo Marg, Ansari Nagar east ,New Delhi, Delhi 110029
Central
DELHI
110029
India |
| Phone |
6204767249 |
| Fax |
|
| Email |
anishashreya268@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
College of nursing AIIMS Delhi |
| Address |
College of nursing ,AIIMS Delhi ,Sri Aurobindo Marg, Ansari Nagar east ,New Delhi ,Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| ANISHA SHREYA |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
Ground floor, room no -3, NMR department ,division 1, SOUTH DELHI
Central
DELHI |
6204767249
anishashreya268@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MRI sound simulation |
MRI sound will be recorded and adjusted to a level(decibel setting) heard by human being in MRI scan room and will be provided as a noise simulation to interventional group.
Total 15-20 min for experiment group before going for MRI procedure and after MRI procedure 10 min approx.
|
| Comparator Agent |
Usual MRI care |
Usual MRI care.
For comparator group before 10 min MRI procedure and after 10 min of MRI procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1) willing to participate,
2) undergoing MRI with or without contrast,
3) alert ,oriented ,undergoing MRI FOR first time
4)age between 18 years to 60 years. |
|
| ExclusionCriteria |
| Details |
1) the patient who are unconscious,
2) critically ill and sedated,
3) having pain score of 3-10 on universal pain assessment scale ,
4) pediatric patient ,
5) having hearing impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety reduction in patient during MRI. |
1) Prior to MRI
2) Immediately after MRI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Co-operation during the MRI procedure |
During the MRI |
| Satisfaction |
Immediately after the MRI procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
24/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Magnetic resonance
imaging (MRI) is
a painless radiological
tool that does not use ionizing radiation. Although Magnetic resonance
imaging (MRI) is considered as
biologically safe and painless, patients experience claustrophobia and anxiety due to the nature of the procedure. During Magnetic resonance
imaging (MRI), the patient lies in a narrow closed cylinder, which causes discomfort and anxiety particularly
in patients with claustrophobia. It is also known that the sound of Magnetic resonance
imaging( MRI) and the loss of control over procedure contributes to the anxiety. I want to conduct the study in order to assess and reduce the anxiety of patient.• Patients in the experimental group
will receive all aspects of standard care. Patients
in the experimental group will be oriented to the MRI procedure using face to
face interaction and power point slides showing real time pictures of MRI room, scanner
and unit as whole. Validated Magnetic resonance imaging (MRI )noise, recorded through
MRI compatible device will be played for patients in order to prepare them for Magnetic resonance
imaging (MRI) noise. Concerns
of the patients regarding MRI will be discussed and solved. |