FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL   
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
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.
 
 
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.


 
Close