- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545086
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.
September 7, 2020 updated by: Institute of Liver and Biliary Sciences, India
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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New Delhi, India, 110070
- Deepika Bist
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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..
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: VBE Group
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.
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Video Based Education and Music Therapy was given as a part of Interventions to relieve anxiety of patients undergoing Magnetic Resonance Imaging
Other Names:
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EXPERIMENTAL: MT Group
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.
|
Video Based Education and Music Therapy was given as a part of Interventions to relieve anxiety of patients undergoing Magnetic Resonance Imaging
Other Names:
|
NO_INTERVENTION: Control Group
Routine Information was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention.
Assessment of Experience, Co-operation was done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to assess the effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Cooperation among patients undergoing Magnetic Resonance Imaging
Time Frame: 45 minutes to 1 hour.
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State Trait Anxiety Inventory-state form (STAI-S) scale, Patients' Scan Experience Scale and Cooperation Scale for MRI Procedure respectively will be use
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45 minutes to 1 hour.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 30, 2019
Primary Completion (ACTUAL)
November 5, 2019
Study Completion (ACTUAL)
November 5, 2019
Study Registration Dates
First Submitted
August 3, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (ACTUAL)
September 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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