Back to resultsEffectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.
Primary Purpose
Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Video Based Education, Music Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging focused on measuring Anxiety, Video Based Education, Music Therapy, Experience, Cooperation, Magnetic Resonance Imaging
Eligibility Criteria
Inclusion Criteria:
- undergoing MRI with or without contrast
- having age between 18- 60 years.
- alert, oriented
- able to comprehend, speak and listen English or Hindi.
- patients without hearing and visual impairment.
- available during period of data collection
Exclusion Criteria:
- unconscious
- critically ill and sedated.
- visiting Radiology Department for other procedures such as Computed Tomography scan, and MRI brain
- having pain score of 3-10 on universal pain assessment scale..
Sites / Locations
- Deepika Bist
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
VBE Group
MT Group
Control Group
Arm Description
Video Based Education was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation and Opinion regarding intervention was done.
Music Therapy was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation and Opinion regarding intervention was done.
Routine Information was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation was done.
Outcomes
Primary Outcome Measures
to assess the effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Cooperation among patients undergoing Magnetic Resonance Imaging
State Trait Anxiety Inventory-state form (STAI-S) scale, Patients' Scan Experience Scale and Cooperation Scale for MRI Procedure respectively will be use
Secondary Outcome Measures
Full Information
NCT ID
NCT04545086
First Posted
August 3, 2020
Last Updated
September 7, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT04545086
Brief Title
Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.
Official Title
Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
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
A study to assess the Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation among Patients undergoing Magnetic Resonance Imaging. This is a Experimental Multiple Interventions Pre test - Post test Design. Three groups namely, Video Based Education group, Music Therapy Group and control groups are there in study.There will be significant difference in the Mean Anxiety Scores, Experience level, and Co-operation level of patients undergoing MRI in Video Based Education , Music Therapy group and Control Group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging
Keywords
Anxiety, Video Based Education, Music Therapy, Experience, Cooperation, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were assigned randomly to three groups
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VBE Group
Arm Type
Experimental
Arm Description
Video Based Education was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation and Opinion regarding intervention was done.
Arm Title
MT Group
Arm Type
Experimental
Arm Description
Music Therapy was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation and Opinion regarding intervention was done.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine Information was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation was done.
Intervention Type
Behavioral
Intervention Name(s)
Video Based Education, Music Therapy
Other Intervention Name(s)
VBE, MT
Intervention Description
Video Based Education and Music Therapy was given as a part of Interventions to relieve anxiety of patients undergoing Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
to assess the effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Cooperation among patients undergoing Magnetic Resonance Imaging
Description
State Trait Anxiety Inventory-state form (STAI-S) scale, Patients' Scan Experience Scale and Cooperation Scale for MRI Procedure respectively will be use
Time Frame
45 minutes to 1 hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
undergoing MRI with or without contrast
having age between 18- 60 years.
alert, oriented
able to comprehend, speak and listen English or Hindi.
patients without hearing and visual impairment.
available during period of data collection
Exclusion Criteria:
unconscious
critically ill and sedated.
visiting Radiology Department for other procedures such as Computed Tomography scan, and MRI brain
having pain score of 3-10 on universal pain assessment scale..
Facility Information:
Facility Name
Deepika Bist
City
New Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.
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