Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance ImagingNCT04545086
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.
A study testing Video Based Education, Music Therapy in people with Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging
- What is being tested?
- Video Based Education, Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 30 Sep 2019to 5 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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..
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Video Based Education, Music Therapy
- Keywords
- Anxiety, Video Based Education, Music Therapy, Experience, Cooperation, Magnetic Resonance Imaging
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Based Education, Music TherapyBehavioural
Also called VBE, MT
Video Based Education and Music Therapy was given as a part of Interventions to relieve anxiety of patients undergoing Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| VBE Group | Experimental | 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. Receives: Behavioral: Video Based Education, Music Therapy |
| MT Group | Experimental | 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. Receives: Behavioral: Video Based Education, Music Therapy |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 minutes to 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start30 Sep 2019
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned randomly to three groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545086
- Sponsor's protocol ID
- 3/19
- Status last verified
- Jan 2020
- First submitted
- 3 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04545086
- Acronym / sponsor ID
- 3/19
- Keywords
- Anxiety, Video Based Education, Music Therapy, Experience, Cooperation, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants were assigned randomly to three groups
| Arm | Type | Receives |
|---|---|---|
| VBE Group | Experimental | Behavioral: Video Based Education, Music TherapyVideo 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. |
| MT Group | Experimental | Behavioral: Video Based Education, Music TherapyMusic 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. |
| Control Group | No intervention | –Routine Information was given before undergoing MRI procedure and Anxiety was assessed within 20 minutes of Intervention. Assessment of Experience, Co-operation was done. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Based Education, Music TherapyAlso: VBE, MTVideo Based Education and Music Therapy was given as a part of Interventions to relieve anxiety of patients undergoing Magnetic Resonance Imaging | Behavioural | MT Group, VBE Group |
Primary outcome
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.
State Trait Anxiety Inventory-state form (STAI-S) scale, Patients' Scan Experience Scale and Cooperation Scale for MRI Procedure respectively will be use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Based Education, Music Therapy in people with Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.