| CTRI Number |
CTRI/2021/08/036052 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
31/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Complementary and Alternative Medicine Therapy- Reiki Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Reiki therapy on pain, depression and quality of life in hospitalized cancer survivors- A Pilot Study. |
|
Scientific Title of Study
|
Effect of Reiki therapy on pain, depression and quality of life in hospitalized cancer survivors-A Pilot Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renuka Deshpande |
| Designation |
Post-graduate Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
09172247652 |
| Fax |
|
| Email |
renukad208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renu Pattanshetty |
| Designation |
Professor and Head, Department of Oncology Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy,JNMC Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448482564 |
| Fax |
|
| Email |
renu_kori@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renuka Deshpande |
| Designation |
Post-graduate Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
09172247652 |
| Fax |
|
| Email |
renukad208@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Renuka Deshpande |
| Address |
KLE Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belgaum, Karnataka, 590010. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Renuka Deshpande |
KLE CANCER HOSPITAL, AND KLE PRABHAKAR KORE HOSPITAL, BELGAVI, KARNATAKA |
KLE Prabhakar Kore Hospital,Nehru Nagar, Belgavi, Karnataka.
Belgaum
KARNATAKA |
9172247652
renukad208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institutional 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 |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Reiki therapy. |
Hands-on Reiki will be given to all the participants of the study on 12 areas of their body for 7 days. The session may last for 30-45 minutes. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. All adult hospitalized cancer patients, of both male and female gender, who are able to comprehend instructions.
2. Age 19-50.
3. Willing to participate. |
|
| ExclusionCriteria |
| Details |
1. Participants diagnosed with other significant comorbidities such as stroke, Alzheimer’s or neurodegenerative disorder.
2.Participants with organic psychiatric disorders, as diagnosed by the psychiatrist.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Depression
|
Baseline and after completion of 7 days of Reiki therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Base line and after completion of 7 days of Reiki therapy. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
01/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
We are conducting this study with an intent to publish. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Reiki therapy has been found to be effective in relieving various symptoms and cure some diseases. As it is an ancient Japanese medicine, the evidence of its effectiveness mainly remains anecdotal. In this study, only patients in the KLE Cancer Hospital and KLE Prabhakar Kore Hospital Belagavi will be included in this study. |