| CTRI Number |
CTRI/2014/08/004937 [Registered on: 27/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
26/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effect of "orientation programme" on the anxiety level of patients undergoing first time radiotherapy for the treatment of cancer |
|
Scientific Title of Study
|
A randomized control trial to assess the effect of orientation programme on anxiety level of patients undergoing first time radiotherapy in Nehru hospital PGIMER, Chandigarh in year 2013-14 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harpreet Kaur |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
national institute of nursing education, PGIMER, Chandigarh |
| Address |
national institute of nursing education, PGIMER , Chandigarh, 160012
national institute of nursing education, PGIMER , Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09465222362 |
| Fax |
--- |
| Email |
harpreetkaurpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhpal kaur |
| Designation |
Lecturer |
| Affiliation |
national institute of nursing education, PGIMER, Chandigarh |
| Address |
national institute of nursing education, PGIMER , Chandigarh, 160012
national institute of nursing education, PGIMER , Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09592894745 |
| Fax |
--- |
| Email |
sukhpal.trehan@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Harpreet Kaur |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
national institute of nursing education, PGIMER, Chandigarh |
| Address |
national institute of nursing education, PGIMER , Chandigarh, 160012
national institute of nursing education, PGIMER , Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09465222362 |
| Fax |
--- |
| Email |
harpreetkaurpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HARPREET KAUR |
| Address |
national institute of nursing education PGIMER chandigarh |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
no applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Harpreet kaur |
Radiotherapy department, Nehru hospital, PGIMER, Chandigarh |
National institute of nursing education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
09592894745
harpreetkaurpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
diagnosed patients of cancer who are undergoing 1st time radiotherapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
routine care- information provided by technician |
| Intervention |
intervention group |
orientation programme in form of booklet and powerpoint slides before undergoing radiotherapy, it was 25-30 min orientation programme. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects undergoing 1st time radiotherapy
•Subjects who are available during the period of data collection.
•Subjects who can read English/ Punjabi/ Hindi.
|
|
| ExclusionCriteria |
| Details |
-Subjects who refuse to participate in the study.
-Subjects undergoing single fraction of radiotherapy
-Subjects below 18 years of age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reducing anxiety |
immediate after radiotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
unpublished |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of orientation programme protocol is to reduce the anxiety level of anxiety in patients undergoing 1st time radiotherapy
Hypothesis of the present study are:
Null Hypothesis (H0)
There is no significant difference in the anxiety level of patients undergoing 1st time radiotherapy with or without orientation programme at the level of significance 0.05.
Alternate Hypothesis (HA)
Orientation programme has significant role in reducing the anxiety of patients undergoing 1st time radiotherapy at the level of significance 0.05.
|