| CTRI Number |
CTRI/2022/02/040454 [Registered on: 21/02/2022] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate effect of Reiki and Deep breathing exercise on
stress |
|
Scientific Title of Study
|
Immediate effect of Reiki and Deep breathing exercise on
stress : A comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA |
| Designation |
INTERN |
| Affiliation |
SDM College of Naturopathy and Yogic Science |
| Address |
NEHA d/o SATHYANARAYANA
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic science Ujire Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7338503023 |
| Fax |
|
| Email |
nehasn36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashikiran |
| Designation |
Professor of research methodologiy |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences |
| Address |
SDM College of naturopathy and yogic science
Ujire
Belthangady
Dakshina kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashikiran |
| Designation |
Professor of research methodologiy |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Naturopathy and Yogic sciences |
| Address |
SDM College of naturopathy and yogic science
Department of Yoga
Ujire
Belthangady
Dakshina kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and nature cure hospital
Shantivana |
|
|
Primary Sponsor
|
| Name |
Neha |
| Address |
SDM College of naturopathy and yogic science Ujire |
| 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 |
| Neha S N |
SDM Yoga and nature cure hospital |
Department of yoga division of yoga Shantivana
Dharmasthala
Dakshina Kannada
KARNATAKA |
7338503023
nehasn36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IMMEDIATE EFFECT OF DEEP BREATHING EXERCISE ON STRESS USING HEART RATE VARIABILITY |
IMMEDIATE EFFECT OF DEEP BREATHING EXERCISE ON STRESS USING HEART RATE VARIABILITY. The subjects will be recruited from Shantivana SDM yoga and nature cure hospital after the screening based on Perceived stress scale. After analysing the inclusion and exclusion criteria randomly 30 subjects are given Deep breathing exercise for 20 minutes. Right before and immediately after the treatment heart rate variability is measured. |
| Intervention |
IMMEDIATE EFFECT OF REIKI ON STRESS USING HEART RATE VARIABILITY
|
IMMEDIATE EFFECT OF REIKI ON STRESS USING HEART RATE VARIABILITY. The subjects will be recruited from Shantivana SDM yoga and nature cure hospital after the screening based on Perceived stress scale.
After analysing the inclusion and exclusion criteria randomly 30 subjects are given reiki healing for 20 minutes. Right before and immediately after the treatment heart rate variability is measured. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals |
|
| ExclusionCriteria |
| Details |
Participants with a history of any systemic diseases or regular medication for any diseases
Skin allergy
Paralysis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceived Stress Scale
Heart rate variability
|
Immediately after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Immediate effect of reiki and deep breathing exercise on stress: A comparative studyThe study subjects will be identified and screened as per the demands of the inclusion & exclusion criteria. Selected subjects will be randomly allocated into two groups by computer generated randomization method. Group 1: Subjects will receive Reiki healing for 20 minutes Group 2: Subjects will receive deep breathing exercises for 20 minutes Subjects will be screened using Perceived stress scale and assessed using heart rate variability before and immediately after the treatment
|