CTRI

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CTRI Number

CTRI/2023/10/058544 [Registered on: 11/10/2023] Trial Registered Prospectively

Last Modified On:

01/08/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Other

Public Title of Study

Short term additional effect of Buteyko Breathing Technique on pain, chest expansion and respiratory rate in post-abdominal surgery patients- An Experimental Study

Scientific Title of Study

Short term additive effect of Buteyko Breathing Technique on pain, chest expansion and respiratory rate in post-abdominal surgery patients- An Experimental Study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Yashvi Thakkar
Designation	MPTH
Affiliation	KJ Somaiya college of Physiotherapy, Mumbai
Address	Amrut Niwas, Kholeshwar near SS Jin, Akola. KJ Somaiya college of Physiotherapy, Ayurvihar, Eastern express highway, Sion, Mumbai 400022 Mumbai MAHARASHTRA 444001 India
Phone	09405880950
Fax
Email	yashvi.t@somaiya.edu

Details of Contact Person
Scientific Query

Name	Dr Shradha Deshpande
Designation	Associate Professor
Affiliation	KJ Somaiya college of Physiotherapy, Mumbai
Address	KJ Somaiya college of Physiotherapy, Ayurvihar, Eastern express highway, Sion, Mumbai 400022 Mumbai MAHARASHTRA 400022 India
Phone	9987154918
Fax
Email	shradha@somaiya.edu

Details of Contact Person
Public Query

Name	Yashvi Thakkar
Designation	MPTH
Affiliation	KJ Somaiya college of Physiotherapy
Address	Amrut Niwas, Kholeshwar near SS Jin, Akola. KJ Somaiya college of Physiotherapy, Ayurvihar, Eastern express highway, Sion, Mumbai 400022 Mumbai MAHARASHTRA 444001 India
Phone	09405880950
Fax
Email	yashvi.t@somaiya.edu

Source of Monetary or Material Support

KJ Somaiya College of Physiotherapy Mumbai

Primary Sponsor

Name	KJ Somaiya College of Physiotherapy Mumbai
Address	KJ Somaiya college of Physiotherapy, Ayurvihar, Eastern express highway, Sion, Mumbai 400022
Type of Sponsor	Other [SELF]

Details of Secondary Sponsor

Name	Address
NIL	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 Shradha Deshpande	KJ Somaiya Hospital & Research Center	2 & 3 floor ICU & Wards, Somaiya Hospital, Ayurvihar Complex, Eastern Express highway Mumbai MAHARASHTRA	09987154918 shradha@somaiya.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committe KJ Somaiya college of physiotherapye	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F\|\|Physical Rehabilitation and Diagnostic Audiology,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Buteyko breathing technique along with standard protocol for post abdominal surgery patients which includes breathing exercises, incentive spirometer, general mobility and strengthening	daily from post operative day 1 - Buteyko breathing technique in addition to other breathing exercises which includes deep breathing exercises (diaphragmatic breathing, segmental expansion, thoracic expansion exercises), incentive spirometer, early mobilization like sitting and assisted walking and mobility of upper limb and lower limb daily along with core strengthening from day 3 post operatively.
Comparator Agent	Standard protocol for post -abdominal surgery patients which includes breathing exercises, incentive spirometer, general mobility and strengthening.	daily breathing exercises includes deep breathing exercises (diaphragmatic breathing, segmental expansion, thoracic expansion exercises), incentive spirometer, early mobilization like sitting and assisted walking and mobility of upper limb and lower limb daily along with core strengthening from day 3 post operatively.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	59.00 Year(s)
Gender	Both
Details	1) An 18 years and above adult of any gender who has undergone abdominal surgery will be included in this study. 2) On the first postoperative day, the patient should have pain more than or equal to 4 on VAS.

ExclusionCriteria

Details

1) Patients who have undergone minor laparoscopic surgery.
2) Patient who has pre-existing cardiac or pulmonary disease.
3) Person with any neurological disease or cognitive impairment.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1) Visual Analog Scale 2) Chest expansion 3) Respiratory rate	Pre evaluation on postoperative day 1, Post evaluation on postoperative day 5

Secondary Outcome

Outcome	TimePoints
Nil	Nil

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

15/10/2023

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)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details
Modification(s)

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

The aim of the study is to evaluate additive effect of Buteyko breathing technique on pain, chest expansion and respiratory rate in post-abdominal surgery patients.

Null hypothesis(H0):

There will be no differential effect of Buteyko breathing technique on pain, chest expansion and respiratory rate in post-abdominal surgery patients.

Alternative hypothesis (H1):

There will be a differential effect of Buteyko breathing technique on pain, chest expansion and respiratory rate in post-abdominal surgery patients.

Objectives:

To determine the additive effect of Buteyko breathing technique along with conventional protocol on pain, chest expansion and respiratory rate using Visual Analog Scale, inch-tape method and observation method respectively in post-abdominal surgery patients

To determine the additive effect of conventional protocol on pain, chest expansion and respiratory rate using Visual Analog Scale, inch-tape method and observation method respectively in post-abdominal surgery patients

To compare the additive effects of Buteyko breathing technique versus conventional protocol on pain, chest expansion and respiratory rate.