| CTRI Number |
CTRI/2025/09/094784 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Reiki Therapy ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Effects Of Reiki Therapy on Anxiety, Pain and Symptoms
Management of Inpatients Receiving Cancer Treatment In a Tertiary
Cancer Hospital: A Pilot Study |
|
Scientific Title of Study
|
The Effects of Reiki Therapy On Anxiety, Pain and Symptom Management, In Patients Receiving Cancer Treatment In a Tertiary Cancer Hospital: A Pilot Study. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Patel |
| Designation |
Nurse D |
| Affiliation |
Tata Memorial Hospital |
| Address |
311, 3rd Floor, Department of Preventive Oncology, Service Block, Tata memorial hospital, Parel East, Mumbai-12
Mumbai MAHARASHTRA 400012 India |
| Phone |
09167092270 |
| Fax |
02224146937 |
| Email |
jyotitmh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jyoti Patel |
| Designation |
Nurse D |
| Affiliation |
Tata Memorial Hospital |
| Address |
311, 3rd Floor, Department of Preventive Oncology, Service Block, Tata memorial hospital, Parel East, Mumbai-12
Mumbai MAHARASHTRA 400012 India |
| Phone |
09167092270 |
| Fax |
02224146937 |
| Email |
jyotitmh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jyoti Patel |
| Designation |
Nurse D |
| Affiliation |
Tata Memorial Hospital |
| Address |
311, 3rd Floor, Department of Preventive Oncology, Service Block, Tata memorial hospital, Parel East, Mumbai-12
Mumbai MAHARASHTRA 400012 India |
| Phone |
09167092270 |
| Fax |
02224146937 |
| Email |
jyotitmh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,Parel,mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Jyoti Patel |
Tata Memorial Hospital |
311, 3rd Floor, Department of Preventive Oncology, Service Block, Parel East, Mumbai-12 Mumbai MAHARASHTRA |
09167092270 02224146937 jyotitmh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control arm |
The control group receives standard care without any additional intervention. |
| Intervention |
Reiki therapy |
The study is an experimental intervention designed to evaluate the effectiveness of Reiki therapy in cancer patients undergoing chemotherapy in a ward and day-care setting. Participants are recruited based on predefined inclusion and exclusion criteria, and informed consent is obtained from all participants prior to enrolment. The study involves two groups: the intervention (experimental) group and the control group. At baseline, all participants undergo a pre-test assessment using validated scales, including the Visual Analog Scale (VAS) for pain intensity, the Brief Pain Inventory (BPI) for the impact of pain on daily activities, the Generalized Anxiety Disorder 7-item scale (GAD-7) for anxiety levels, the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression, Effectiveness of Reiki Therapy and the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction Scale to measure treatment satisfaction and psychosocial impact.
The intervention group receives a single Reiki session administered by a trained Reiki therapist. The session lasts for 30 minutes and is conducted 30 minutes before the administration of chemotherapy. In contrast, the control group receives standard care without any additional intervention. Following the intervention, all participants undergo a post-test assessment using the same scales to evaluate changes in pain, anxiety, and psychosocial outcomes. The primary outcome of the study is to determine the effectiveness of Reiki therapy in alleviating pain, reducing anxiety, and enhancing psychosocial satisfaction among cancer patients. Statistical analysis is performed to compare pre- and post-test scores between the two groups and assess the impact of the intervention. This methodology ensures a comprehensive evaluation of Reiki therapy as a complementary approach in the oncology setting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18 years or older) diagnosed with cancer and receiving systemic treatment at a tertiary cancer hospital
Patients experiencing anxiety pain and other symptoms related to their cancer or their treatment
Patients willing to participate in the Reiki therapy sessions and provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients with cognitive impairments or mental health conditions that may interfere with their ability to provide informed consent.
Patients who have received Reiki therapy within the past 3 months. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety levels, pain intensity, and treatment satisfaction. |
These measures will be assessed at baseline, immediately after one session of Reiki , and
post-test The study will also collect data on patient satisfaction with the Reiki
therapy/experience of receiving chemotherapy. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2025 |
| Date of Study Completion (India) |
28/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/05/2026 |
|
Estimated Duration of Trial
|
Years="26" Months="1" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is an experimental intervention designed to evaluate the effectiveness of Reiki therapy in cancer patients undergoing chemotherapy in a ward and day-care setting. Participants are recruited based on predefined inclusion and exclusion criteria, and informed consent is obtained from all participants prior to enrollment. The study involves two groups: the intervention (experimental) group and the control group. At baseline, all participants undergo a pre-test assessment using validated scales, including the Visual Analog Scale (VAS) for pain intensity, the Brief Pain Inventory (BPI) for the impact of pain on daily activities, the Generalized Anxiety Disorder 7-item scale (GAD-7) for anxiety levels, the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression, the Effectiveness of Reiki Therapy, and the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction Scale to measure treatment satisfaction and psychosocial impact. The intervention group receives a single Reiki session administered by a trained Reiki therapist. The session lasts for 30 minutes and is conducted 30 minutes before the administration of chemotherapy. In contrast, the control group receives standard care without any additional intervention. Following the intervention, all participants undergo a post-test assessment using the same scales to evaluate changes in pain, anxiety, and psychosocial outcomes. The primary outcome of the study is to determine the effectiveness of Reiki therapy in alleviating pain, reducing anxiety, and enhancing psychosocial satisfaction among cancer patients. Statistical analysis is performed to compare pre- and post-test scores between the two groups and assess the impact of the intervention. This methodology ensures a comprehensive evaluation of Reiki therapy as a complementary approach in the oncology setting. |