| CTRI Number |
CTRI/2025/09/094072 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| 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
|
A STUDY TO UNDERSTAND THE EFFECT OF COLD, TEPID, AND HOT SHOWER ON CARDIAC AND RESPIRATORY PARAMETERS IN HEALTHY VOLUNTEERS
|
|
Scientific Title of Study
|
EFFECT OF COLD, TEPID AND HOT SHOWER ON AUTONOMIC VARIABLES IN HEALTHY INDIVIDUALS: A THREE-ARMED RANDOMIZED TRIAL |
| 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 Yashaswini |
| Designation |
MD Scholar |
| Affiliation |
SDM college of Naturopathy and Yogic Sciences |
| Address |
Department of Natural therapeutics, SDM college of Naturopathy
and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7338577347 |
| Fax |
|
| Email |
yashuysd11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashaswini |
| Designation |
MD Scholar |
| Affiliation |
SDM college of Naturopathy and Yogic Sciences |
| Address |
Department of Natural therapeutics, SDM college of Naturopathy
and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7338577347 |
| Fax |
|
| Email |
yashuysd11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bindu G V |
| Designation |
Assistant professor |
| Affiliation |
SDM college of Naturopathy and Yogic Sciences |
| Address |
SDM college of Naturopathy
and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital, shantivana, Dharmasthala, Belthangady, Dakshina kannada, karnataka, India - 574216 |
|
|
Primary Sponsor
|
| Name |
Dr Yashaswini |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady,
Dakshina Kannada, India - 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 Yashaswini |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, shantivana |
COE, Department of
Natural Therapeutics,
Shantivana,
Dharmasthala,
Belthangady, Dakshina
Kannada, Karnataka,
India - 574216
Dakshina Kannada
KARNATAKA |
07338577347
yashuysd11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COLD SHOWER |
The cold water of 15 degree Celcius to 20 degree Celcius is applied.This will be made to first fall from the shower head in the form of rain douche to the feet, first one and then the other being held in proper position for few seconds each, then the water is made to fall upon the hands, arms, shoulders, back and lastly upon the chest and abdomen. The patient will be instructed to actively be in motion during the application, flexing the lower limbs by raising the feet alternatively, turning around first in one direction and then the other, rubbing the chest with the hands. |
| Comparator Agent |
HOT SHOWER |
The hot water of 36 degree Celcius to 40 degree Celcius is applied. This will be made to first fall from the shower head in the form of rain douche to the feet, first one and then the other being held in proper position for few seconds each, then the water is made to fall upon the hands, arms, shoulders, back and lastly upon the chest and abdomen. The patient will be instructed to actively be in motion during the application, flexing the lower limbs by raising the feet alternatively, turning around first in one direction and then other, rubbing the chest with hands. |
| Intervention |
TEPID SHOWER |
The tepid water of 26.6 degree Celcius to 33.3 degree Celcius is applied. This will be made to first fall from the shower head in the form of rain douche to the feet, first one and then the other being held in proper position for few seconds each, then the water is made to fall upon the hands, arms, shoulders, back and lastly upon the chest and abdomen. The patient will be instructed to actively be in motion during the application, flexing the lower limbs by raising the feet alternatively, turning around first in one direction and then the other, rubbing the chest with the hands. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate in the study and gives written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Weak and debilitating individuals.
2. Subjects intolerant to cold.
3. Systemic illness.
4. Subjects with open wounds.
5. Had caffeine 24 hours before.
6. Female subjects during menstruation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Heart rate variability
2. Galvanic skin response. |
Pre, Post 1(immediately after intervention),Post 2(30 minutes after intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Blood pressure
2. Respiratory rate |
Pre, Post 1(immediately after intervention),Post 2(30 minutes after intervention) |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
01/09/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 randomized controlled trial aims to assess and compare the acute effects of cold (15 - 20°C), tepid (26.6 - 33.3°C), and hot (36 - 40°C) showers on autonomic parameters - heart rate variability (HRV), blood pressure, respiratory rate, and galvanic skin response (GSR), in healthy individuals aged 18 - 25 years. Ninety-three participants will be randomized into three intervention arms (n=31 each) , each receiving a 10-minute shower intervention. There is a significant gap in scientific literature concerning the direct effects of different shower temperatures on autonomic function, despite the widespread use of hydrotherapy in both traditional and naturopathic medicine. Existing studies have primarily focused on immersion-based hydrotherapy or isolated effects of cold or hot exposure, with limited research on shower bathing, which is more practical and widely practiced in daily life. This study integrates modern autonomic measurements and offers a comparative model across three temperature ranges, providing objective evidence on how different water temperatures modulate physiological stress responses. The findings may help refine temperature-specific hydrotherapy protocols for promoting autonomic balance, stress reduction, and cardiovascular well-being in clinical naturopathic settings. |