| CTRI Number |
CTRI/2023/08/056030 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [visual rehabilitation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect of visual rehabilitation |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of nurse led visual rehabilitation on visual outcome and quality of life among patients with visual deficit due to sellar/suprasellar tumor operated in neurosurgery unit in PGIMER, Chandigarh (2022-2024) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti |
| Designation |
Student |
| Affiliation |
National institute of nursing education |
| Address |
Room no. 118 National institute of nursing education, Post graduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
sweet.bharti2263@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Dhandapani |
| Designation |
Associate Professor |
| Affiliation |
National institute of nursing education |
| Address |
Room no. 302 National institute of nursing education, Post graduation institute of medical research and education, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
manjuseban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharti |
| Designation |
student |
| Affiliation |
National institute of nursing education |
| Address |
Room no. 118 National Institute of Nursing education, post graduate institute of medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9555982597 |
| Fax |
|
| Email |
sweet.bharti2263@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of nursing education, Post graduate institute of medical education and research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Bharti |
| Address |
National institute of nursing education |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manju Dhandapani |
National institute of nursing education |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bharti |
Post graduate institute of medical education and research |
Nehru hospital, Post graduate institute of medical education and research, Chandigarh pin code 160012
Chandigarh
CHANDIGARH |
9555982597
sweet.bharti2263@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D3A8||Other benign neuroendocrine tumors, (2) ICD-10 Condition: E236||Other disorders of pituitary gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led visual rehabilitation |
It include certain visual
scanning exercises, eye muscles strengthening exercises and some compensatory exercises to get the visual outcome and to improve the quality of life among patients. |
| Comparator Agent |
Routine care |
They will do the regular exercise as they are doing. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a.) patients with sellar/suprasellar tumor with impaired vision and having visual symptoms.
b.) patients with sellar/suprasellar tumor operated in Nehru, Hospital, PGIMER, CHD
c.) patient those are willing to participate |
|
| ExclusionCriteria |
| Details |
a.) sellar/suprasellar tumor patient with other vision problem or disease condition like cataract, blindness, glaucoma etc.
b.) patient with impaired consciousness
c.) patient with pituitary microadenoma or tumor less than 2 cm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
visual outcome
|
14th day
1 month
3rd month of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual quality of life |
14th day of discharge
1st month of discharge
3rd month of discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
04/08/2023 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The Nurse led visual rehabilitation protocol include certain visual scanning exercises , muscle strengthening exercises and compensatory exercises which will be practiced by the post surgery patients till discharge and booklet is provided to them for practice at home then patient is re assessed after 14th day, 1 month and 3rd month of discharge. |