| CTRI Number |
CTRI/2024/04/064969 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Spiritual Therapy ] |
| Study Design |
Other |
|
Public Title of Study
|
effect of spiritual therapy on distress, spiritual wellbeing, hope and coping |
|
Scientific Title of Study
|
A study to assess the effect of spiritual therapy on distress, spiritual wellbeing, hope and coping among cancer patients undergoing external beam radiation therapy (EBRT) at |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avneet Kaur |
| Designation |
PG student |
| Affiliation |
Baba Farid university of health sciences , Faridkot |
| Address |
GGS medical college and Hospital, cancer department room no. 7
Faridkot
PUNJAB
151203
India |
| Phone |
9779823368 |
| Fax |
|
| Email |
avneetrai80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preksha Sharma |
| Designation |
Associate Professor |
| Affiliation |
University College of Nursing, Faridkot |
| Address |
University College of Nursing, Faridkot
University College of Nursing, Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9478964460 |
| Fax |
|
| Email |
prekshamaheshwari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avneet Kaur |
| Designation |
PG student |
| Affiliation |
University College of Nursing, Faridkot |
| Address |
University College of Nursing, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9779823368 |
| Fax |
|
| Email |
avneetrai80@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
GGS medical college and Hospital, cancer department room no. 7 |
| Type of Sponsor |
Other [Nill] |
|
|
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 Preksha Sharma |
GGS medical college and Hospital Faridkot |
Guru Gobind Singh Medical College Faridkot, Cancer department room no. 7., day care .
Faridkot
PUNJAB |
9779823368
prekshamaheshwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Spiritual Therapy |
Yoga, meditation, deep breathing exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
– Adult cancer patients (aged 18 years and above) undergoing external beam radiation therapy at GGSMC&H, Faridkot.
– Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
– Patients who are not present at the time of study.
– Patients who are not able to cooperate due to physical, emotional or
medical conditions.
– Already completed the first day dose of current EBRT. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spiritual Therapy may reduce the level of distress among cancer patients after 6 weeks |
Spiritual Therapy may reduce the level of distress among cancer patients after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spiritual Therapy may increase spiritual well being of cancer patients along with hope and coping among patients |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study will check the effectiveness of Spiritual Therapy on selected parameters of distress, spiritual wellbeing, hope and coping among Cancer patients undergoing external beam radiation therapy. The objective of the study is to assess the distress, spiritual well being, hope and coping among cancer patients undergoing EBRT at baseline. To assess the effect of spiritual therapy distress, spiritual well being, hope and coping among cancer patients undergoing EBR. To assess the relationship of distress, spiritual well being, hope and coping among cancer patients undergoing EBRT at baseline with each other. The sample size will be 100 random allocation of subject i.e. 50 in interventional group and 50 in conventional group will be used for data collection. Content validity will be determined by expert’s opinion. Analysis will be done using descriptive and inferential statistics. |