CTRI

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CTRI Number

CTRI/2021/11/038225 [Registered on: 24/11/2021] Trial Registered Prospectively

Last Modified On:

27/07/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Yoga & Naturopathy

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Device guided Breathing to reduce arousal in patients with chronic pain

Scientific Title of Study

Effect of yoga breathing techniques on autonomic and respiratory variables in patients with chronic pain

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Shirley Telles
Designation	Director of Research
Affiliation	Patanjali Research Foundation(Trust)
Address	Patanjali Research Foundation(Trust) Patanjali Yogpeeth, Haridwar,249405, Uttarakhand Hardwar UTTARANCHAL 249405 India
Phone	9897963254
Fax
Email	office@prft.in

Details of Contact Person
Scientific Query

Name	Dr Shirley Telles
Designation	Director of Research
Affiliation	Patanjali Research Foundation(Trust)
Address	Patanjali Research Foundation(Trust) Patanjali Yogpeeth, Haridwar,249405, Uttarakhand Hardwar UTTARANCHAL 249405 India
Phone	9897963254
Fax
Email	office@prft.in

Details of Contact Person
Public Query

Name	Dr Shirley Telles
Designation	Director of Research
Affiliation	Patanjali Research Foundation(Trust)
Address	Patanjali Research Foundation(Trust) Patanjali Yogpeeth, Haridwar,249405, Uttarakhand Hardwar UTTARANCHAL 249405 India
Phone	9897963254
Fax
Email	office@prft.in

Source of Monetary or Material Support

Patanjali Research Foundation (Trust)

Primary Sponsor

Name	Patanjali Research Foundation Trust
Address	Patanjali Yogpeeth phase 1 Haridwar-249405, Uttarakhand, India.
Type of Sponsor	Research institution

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 Shirley Telles	Patanjali Research Foundation (Trust)	Autonomic Lab, Department of Yoga Research, 2nd Floor, Sadbhawana Building Patanjali Yogpeeth phase-I, Bahadrabad, Hardwar UTTARANCHAL	9897963254 office@prft.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional EthicsCommittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M95\|\|Other acquired deformities of musculoskeletal system and connective tissue,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	control	Gazing at metronome with out any instruction to modify breath The total duration of the intervention session will be 23 minutes. The details of the session as given below (i) Pre State[5 minutes] (ii) Training period [2 minutes] (iii) During State [11 minutes includes epoch 1 (5 minutes) 1 minute rest and epoch 2 (5 minutes)] (iv) Post State [5 minutes]
Intervention	Device guided breathing	(i) Device guided breathing with exhale greater than inhale (ii) Device guided breathing with exhale equal to inhale The total duration of the intervention session will be 23 minutes. The details of the session as given below (i) Pre State[5 minutes] (ii) Training period [2 minutes] (iii) During State [11 minutes includes epoch 1 (5 minutes) 1 minute rest and epoch 2 (5 minutes)] (iv) Post State [5 minutes]

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Patients with non-malignant chronic pain arising from musculoskeletal system more than 3 months based on their case history and semi-structured interview.

ExclusionCriteria

Details

Patients having diseases such as cardiovascular disease, respiratory disorders, malignancy and patients with pain from recent injuries, fractures, post surgical pain will be excluded from the study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
(i) Heart rate variability(HRV) (ii) Respiration rate(RR) (iii) Blood pressure(BP)	Before, during and after the interventions

Secondary Outcome

Outcome	TimePoints
(i) State-Trait Anxiety Inventory (STAI-s) (ii) The brief mood introspection scale (BMIS)	Before and after the interventions

Target Sample Size

Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

N/A

Date of First Enrollment (India)

15/12/2021

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

The objective of the present study is to assess the effect of device guided breathing on (i) physiological and (ii) psychological variables in patients with non-malignant chronic pain of both genders having age ranges from 20 to 60 years. The participants will be recruited from an alternative and complementary therapy center located in North of India. All the participants will be allocated into 3 groups randomly by computer generated random numbers. All the participants of three groups will receive interventions i.e. (i) Device guided breathing with exhale greater than inhale , (ii) Device guided breathing with exhale equal to inhale, and (iii) Control session having instructions to gazing at metronome respectively. The participants will be assessed for heart rate variability, respiration rate, blood pressure, state anxiety and mood.