| CTRI Number |
CTRI/2025/07/090831 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Multimedia Education Before Cerebral Angiography on Anxiety and Vital Signs in Patients |
|
Scientific Title of Study
|
Effect of multimedia based pre procedural education on physiological and psychological parameters of patient undergone cerebral angiography: A randomized controlled clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAKESH M |
| Designation |
NURSING OFFICER |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH INSTITUTE,CHANDIGARH |
| Address |
Department of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592926644 |
| Fax |
|
| Email |
m36rakesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AJAY KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH INSTITUTE,CHANDIGARH |
| Address |
Division of Neuroimaging and Interventional Neuroradiology, Department of Radiodiagnosis and Imaging, PGIMER, Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209385 |
| Fax |
|
| Email |
ajay2509@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Dhandapani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
Manjuseban@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Radiodiagnosis and Imaging |
| Address |
Department of Radiodiagnosis and Imaging, PGIMER, Chandigarh, India,160012 |
| 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 |
| Dr AJAY KUMAR |
Postgraduate Institute of Medical Education and Research (PGIMER) |
Room No. 20, Advanced Vascular Interventional Lab, Department of Radiodiagnosis and Imaging, Ground Floor, Nehru Hospital, PGIMER, Chandigarh, India – 160012.
Chandigarh
CHANDIGARH |
9914209385
ajay2509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z049||Encounter for examination and observation for unspecified reason, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care without multimedia intervention |
The comparator agent will be given only standard verbal pre-procedural instructions |
| Intervention |
The Multimedia Based Educational Intervention |
The multimedia based educational intervention to teach patients about cerebral angiography which consisted of four main sections: explaining the cerebral angiography, pre, during, and post-cerebral angiography instructions. The principal investigator will deliver the educational program via multimedia tools including video and digital pamphlet in English, Hindi and Punjabi languages to the patients in the experimental groups 15 min before cerebral angiography. Patients will be consistently encouraged and actively participate in their educational process. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals aged 19 to 60 years.
2.Being first time elective diagnostic cerebral femoral and radial catheterization recipients.
3.Having a sheath size of 5/6 french.
4.Free from certain medical conditions such as diabetes associated sensory issues or psychiatric diseases.
5.No visual or hearing impairments.
|
|
| ExclusionCriteria |
| Details |
1.Recent anticoagulant use,
2.Compromised skin integrity at the access site,
3.History of bleeding disorders.
4.Disoriented and loss of consciousness
5.Having vascular closure device
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in anxiety levels as measured by The State-Trait Anxiety Inventory (STAI) |
1 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Stabilization of vital signs such as blood pressure, heart rate, respiratory rate and Spo2
2)Reduction in discomfort as measured by the Discomfort scale
3)Reduction in pain as measured by the Numerical rating scale pain scores
4)Reduced incident of hematoma as measured by hematoma scale
|
1)1hr
2)For hematoma after 8 hrs |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The study will use a randomized controlled trial with a non equivalent control group design to assess the effects of multimedia based pre procedural education on patients undergoing cerebral angiography. A total of 60 participants will be divided equally into experimental and control groups. The experimental group will receive multimedia education via video and digital pamphlet in English,Hindi,and Punjabi 15 min cerebral angiography, while the control group will receive routine care .Outcomes will include physiological and psychological parameters, measured using tools such as vital signs table ,State Trait Anxiety inventory,Discomfort scale,pain rating and hematoma scale.Post test data will be collected after 1 hr of the procedure and analysed using descriptive and inferential statistics. |