| CTRI Number |
CTRI/2025/07/091666 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Randomized Control Trial To Study The Effect Of Warm Footbath And Aromatherapy On The Level Of The Stress, Sleep Quality And Fatigue Among Patients With Cancer Undergoing Chemotherapy And Radiation Therapy In R.I.M.S. Ranchi |
|
Scientific Title of Study
|
A randomized control trial to study the effect of warm footbath and aromatherapy on the level of the stress, sleep quality and fatigue among patients with cancer undergoing chemotherapy and radiation therapy in selected hospitals in Ranchi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakhan Majhee |
| Designation |
Additional Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Pharmacology, Rajendra Institute of Medical Sciences (R.I.M.S), Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9431402029 |
| Fax |
|
| Email |
drlakhan35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Mamta Toppo |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
College of Nursing,
Rajendra Institute of Medical Sciences , Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9430102561 |
| Fax |
|
| Email |
kujurmamta2204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Arpita Rai |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Oral Medicine and Radiology, Dental Institute, Rajendra Institute of Medical Sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9871743893 |
| Fax |
|
| Email |
arpita.dirims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Ranchi, Jharkhand - 834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Rajendra Institute of Medical Sciences,Bariatu,Ranchi Jharkhand - 834009 |
| Type of Sponsor |
Government medical college |
|
|
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 Lakhan Majhee |
Rajendra Institute of Medical Sciences |
Department of Oncology, Department of Medicine, Department of Surgery,Rajendra Institute of Medical Sciences,Bariatu, Ranchi
Ranchi
JHARKHAND |
9431402029
drlakhan35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
The patients in the control group will be given daily hospital routine care. |
| Intervention |
Warm Footbath and Lavender Aromatherapy |
Warm Footbath:
Explained the procedure to the patient and informed consent will be obtained.
The patient was asked to sit in a comfortable position and all the materials were assembled near the patient.
The basin is filled with hot water. By using lotion thermometer the temperature of the water was checked. The temperature of the water was maintained between 40-44oC .The patients allowing them to touch the water by using their palms.
Then the patient was instructed to immerse the foot till the ankles. The patient is covered with a sheet and warm foot bath was given for 15-20 minutes for fifteen consecutive days.
The temperature of the water was checked in between the procedure. Hot water was added when the water cools.
The patient was instructed to dry the legs after the procedure.
Lavender Aromatherapy:
The patients in the experimental group will be given aromatherapy
lavender oil 5ml mixed with boiled water and asked patients to inhale for 15
20 minutes using steam inhalor .The patients in the control group will be given the usual treatment.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cancer undergoing chemotherapy and radiation therapy who were admitted at R.I.M.S. , Ranchi.
Patients who were willing to participate in this study.
Both male and female patients.
Patients who can speak and understand Hindi.
|
|
| ExclusionCriteria |
| Details |
Patients who are unconscious.
Patients who were receiving chemotherapy and radiation therapy and having other hereditary diseases like diabetic foot ulcers, paralysis of lower extremities.
Patients who are terminally ill.
Patients who are having mental illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of warm footbath and aromatherapy on the level of stress, sleep and fatigue among patients with cancer undergoing chemotherapy and radiation therapy in experimental group is greater than control group. |
Time points for the study will be baseline , 2 weeks and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
04/08/2025 |
| 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="2"
Months="0"
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
|
This study is a randomized, doubleblind, parallel group, comparing the safety and efficacy of warm footbath and Aromatherapy for 1 month in 75 cancer patients undergoing chemotherapy and radiation therapy that will be conducted in R.I.M.S. Ranchi in India,. The primary outcome measures will be the effectiveness of Warm Footbath and Aromatherapy on the level of stress, sleep and fatigue among patients with cancer undergoing chemotherapy and radiation therapy in experimental group is greater than control group. |