| CTRI Number |
CTRI/2024/02/062388 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Other (Specify) [Breathing Exercises to prevent complications and early rehabilitation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Respiratory Function in Cardiac Surgery Patients: The Impact of Rhythmic Breathing Technique. |
|
Scientific Title of Study
|
Effect of rhythmic breathing on selected respiratory parameters of patients underwent cardiac surgery: A randomized controlled trial |
| Trial Acronym |
RB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Dhanda |
| Designation |
Student |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of nursing, All India Institute of Medical Sciences, Jodhpur, Basni Phase-2, Jodhpur
VPO Gatauli, Tehsil julana, District Jind, Haryana
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9813551927 |
| Fax |
|
| Email |
poojadhanda358@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nipin Kalal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room No.: CN-106, College of nursing, AIIMS, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8955945598 |
| Fax |
|
| Email |
kalalnipin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nipin Kalal |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Room No.: CN-106, College of nursing, AIIMS, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8955945598 |
| Fax |
|
| Email |
kalalnipin@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
All India Institute of Medical Sciences, Jodhpur, Rajasthan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nipin Kalal |
All India Institute of Medical Sciences, Jodhpur |
Surgery department, Cardiovascular & thoracic surgery division, Room no. 6A,6D,Intensive care unit
Jodhpur
RAJASTHAN |
8955945598
kalalnipin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Jodhpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, (2) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rhythmic breathing |
Rhythmic breathing technique: This will be provided three times a day for a duration of 15-20 minutes.
Ujjayi Breath: This is a three-step pranayama that uses Ujjayi breath and specific positions of the arms to transport and fill prana (life force energy) to the lower, middle and upper parts of the lungs, both lungs Is fully inflated.
This pranayama requires a gentle glottis contraction along with the upper opening of your larynx, as would normally happen while swallowing. Both inhalation and exhalation are done through the nose, with the lips gently closed, directing the breath towards the back of the throat.
When the throat muscles are contracted, it produces a hissing sound or soft snoring, similar to the sound of the ocean, which is why it is also known as ocean breath. As the throat passage becomes narrower, the speed of air increases.
Ujjayi Pranayama will be performed with the patients eyes closed in Vajrasana (ie, sitting with legs bent and spine straight), those who cannot sit in Vajrasana can practice in any comfortable position. It is a slow and deep breathing technique performed with a specific ratio of inhalation, exhalation and retention of breath.
1. First step of Pranayama, place the thumbs on the hip bones, hands parallel to the ground in the line of the navel. Then take a normal breath in and exhale while leaving the body loose. Then take another normal breath and exhale.
Now with Ujjayi, inhale for a count of 1, 2, 3, and 4, then hold for a count of 1, 2, 3, and 4), and then Exhale on the count of 1, 2, 3, 4, 5, and 6. Finally, hold your breath for a count of 1 and 2. Repeat this for eight cycles and finally rest for 30 seconds to a minute while placing the palms on the knees towards the sky.
2. Second phase of Pranayama, keeping the hands parallel to the ground, place the thumbs deep in your armpits, relax the shoulders, have a slight smile on the face, keep the spine straight.
First of all, take normal breath and repeat the same as the first step of Pranayama in the process of eight cycles, and finally rest for 30 seconds to one minute while placing the palms on the knees towards the sky.
3. Finally, for the third step of pranayama, raise the elbows, biceps touching the ears, place the palms on the shoulder blades, and ensure that they are not overlapping, keeping the spine straight.
First of all, take normal breath and repeat the same as the first step of Pranayama in the process of eight cycles, and finally rest for 30 seconds to one minute while placing the palms on the knees towards the sky.
|
| Comparator Agent |
Standard routine care |
Prescriptions advised by the physician |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age (18-65 years)
2. Patients who will be available and willing to participate in the study during data collection.
3. Patients who can understand Hindi and English language
|
|
| ExclusionCriteria |
| Details |
1. Critically ill patients with multiple disorders.
2. Patients on mechanical ventilator.
3. Patients with ongoing chest pain.
4. Patients with arrhythmia needed for pacemaker and intra-aortic balloon
• Patients with chronic heart failure.
• Patient with post-operative renal failure
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Breath holding time & cardiopulmonary endurance |
One time follow-up at 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ABG Values |
One time follow-up at 7th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research Problem Statement Effect of rhythmic breathing on selected respiratory parameters of patients underwent cardiac surgery: A randomized controlled trial Research approach: Quantitative research approach will be used in the present study Research design: Randomised controlled trial (post-test only control group design) Target population: Post-operative cardiac surgery patients Data collection procedure Step 1: Enrolment The patients with CABG and Valve replacement at CTVS Department, AIIMS Jodhpur will be recruited and informed written consent will be obtained post-operatively from the patients for conducting the study. Confidentiality regarding the data will be assured so as to get cooperation throughout the procedure of data collection. Step 2: Baseline Data collection The baseline data will be collected post-operatively from both experimental & control group. It will include the sociodemographic variables & clinical profile sheet. Step 3: Randomisation Participants will be randomized into two groups, intervention and control group, by Block Randomization method. Step 4: Intervention: Intervention will be provided post-operatively after extubating to the experimental group for 6 days. Rhythmic Breathing technique: It will be provided three times a day for the duration of 15-20 minutes.
Step 5: Collection of data: The patients from both experimental & control group will be assessed for respiratory parameters on 7th day after rhythmic breathing technique. Interview technique will be used for the data collection for respiratory parameters datasheet. Breath holding time will be measured by the help of stopwatch & will be entered in the breath holding time datasheet. ABG will be assessed by the ABG machine & will be entered in the ABG datasheet. Findings of 6-MWT & BORG Scale will be entered in 6-MWT appendix. Plan for data analysis Statistical analysis will be performed using Statistical Package of Social Sciences Programme (SPSS). Descriptive statistics and inferential statistics will be used for data analysis. The level of significance will be set as p<0.05. |