| CTRI Number |
CTRI/2023/05/053149 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
08/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of warm foot bath with ice massage to head and spine on Autonomicity |
|
Scientific Title of Study
|
Effect of warm foot bath with ice massage to head and spine on Autonomic variables in healthy individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr pavan K S |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8105940447 |
| Fax |
|
| Email |
kspavan1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr pavan K S |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire Belthangady
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8105940447 |
| Fax |
|
| Email |
kspavan1997@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashikiran H C |
| Designation |
Dean division, Department of research studies |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences, Ujire, Belthangady, 574240
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
7022776445 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
|
|
Primary Sponsor
|
| Name |
Dr pavan K S |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire, Belthangady, Dakshina kannada 574240 |
| 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 |
| Dr Pavan K S |
Sri Dharmasthala Manjunatheshwara Yoga and Naturecure hospital Shanthivana |
Department of Natural Therapeutics, Shanthivana,
Dharmasthala Dakshina Kannada KARNATAKA |
8105940447
kspavan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic sciences Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ice massage to head and spine |
Subjects are asked to lie on a massage table in prone position. Ice (1°C–2°C) was filled in a rubber bag (ice bag). Then, ice bag was applied to head (3–5 s each on the crown, back, right and left sides) followed by spine (3–5 s in the cervical, 6–10 s in the thoracic, and 3–5 s each in the lumbar and sacral regions) by continuous displacements. The same procedure was repeated for a period of 20 min. After the completion of ice massage, the water is wiped off with a towel . The intervention was provided by one of the investigators.
Duration: 20 minutes |
| Comparator Agent |
Warm foot bath |
Subjects are asked to sit in a chair and are directed to immerse both legs in a plastic bucket filled with warm water. The temperature of the water is maintained at 37o – 41oC and the duration of the intervention is 20 minutes. The lower limbs are immersed approximately 20 cm from the sole of the foot to above completely covering the calf muscles in the warm water. After the completion of foot bath, the water is wiped off with a towel.
Duration: 20 minutes |
| Intervention |
Warm foot bath with ice massage to head and spine |
Subjects are asked to sit on a tripod stool and are directed to immerse both legs in a plastic bucket filled with warm water. The temperature of the water is maintained at 37o–41oC and the duration of the intervention is 20 minutes. The lower limbs are immersed approximately 20 cm from the sole of the foot to above completely covering the calf muscles in the warm water along with it, ice (1°C–2°C) filled in a rubber bag (ice bag) has applied to head (3–5 s each on the crown, back, right and left sides) followed by spine (3–5 s in the cervical, 6–10 s in the thoracic, and 3–5 s each in the lumbar and sacral regions) by continuous displacements. The same procedure was repeated for a period of 20 min. After the completion of foot bath and ice massage the water is wiped off with a towel.
Duration: 20 minutes |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects with systemic or mental illness.
2. Subjects with regular use of medication.
3. Subjects with open wounds.
4. Weak and debilitated subjects.
5. Females during menstruation.
6. Subjects who consume alcohol and nicotine.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Blood pressure
2. Heart rate variability |
Baseline and 5 minutes post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Digital pulse propagation index |
Baseline and 5 minutes post intervention |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In
hydrotherapy, baths are one of the ways to apply water to the human body for
therapeutic purposes. Baths can be a full or partial immersion of the body in
the water of different temperatures. Since ancient times,
thermoneutral, warm and hot temperatures (33.5°C - 41°C) have been widely used
for foot baths.
In
hydrotherapy, ice is a therapeutic agent used in medicine as an integral part
of injury treatment and rehabilitation. The application of ice has been shown to produce
physiological changes. Ice massage is performed by means of a rubber bag filled
with ice or ice water to the head and spine for durations of 15 to 20 minutes. It is a simple and inexpensive procedure, and a study
comparing three types of cold simulations (ice application to hands, forehead,
and face) and their effects on cardiovascular adaptations (E.g., application of
ice to sites other than the hands, including the forehead and face), Blood
Pressure (BP) and Heart Rate (HR),(16) were reduced, with a significant improvement in Heart Rate Variability
(HRV) toward vagal dominance. The ice pack or intense, prolonged cold applications to the
back have a sedative effect on the spinal cord and also on the vasomotor
sympathetic nerve centers.
There are few
studies on ice massage to the head and spine alone on blood pressure and HRV on
warm foot bath as a single treatment in different groups, but no studies on the
combination of both treatments.
Because
individual treatments have their own benefits, they usually result in greater
effects when combined. The present study aimed to investigate the effect of
warm foot bath with ice massage to the head and spine on autonomic variables in
healthy individuals. Grouping:
Subjects will be divided into three
groups by computer generated randomization:
·
Group 1: Warm foot bath with ice massage to head and spine
for 20 minutes (n ≥ 30).
·
Group 2: Warm foot bath for 20 minutes (n ≥30).
·
Group 3: Ice massage to head and spine for 20
minutes (n ≥ 30) Method:
·
Institutional ethical clearance
will be obtained prior to the conduct of the study.
·
Informed consent will be obtained
from the individuals by explaining the study objectives, methods, intervention
and will be obtained from every participant after an appraisal about the study
protocol.
·
All the rights of the individual
pertaining to the study in their own language.
·
After selecting the eligible
subjects.
·
Allotment will be done by using a
Computer-generated random number.
·
Group 1: Warm foot bath with ice massage to
head and spine for 20 minutes (n
30).
·
Group 2: Warm foot bath for 20 minutes (n ≥ 30).
·
Group 3: Ice massage to head and spine for 20 minutes (n ≥
30).
·
Assessments will be done before and
after the intervention (Fig. 1).
· Data collected will be tabulated
and analyzed using appropriate statistical methods.
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