| CTRI Number |
CTRI/2024/05/067318 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring the feasibility and safety of the chest PNF technique on pain, oxygen saturation, respiratory rate, and breathing pattern after upper abdominal surgery patients—pre and post study. |
|
Scientific Title of Study
|
Feasibility and safety of neurophysiological facilitation of respiration on pain, oxygen saturation, respiratory rate and breathing pattern in upper abdominal surgery patients.: Quasi-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 |
Dr Vrunda Charkha |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy,
OPD-4, MGM Institute of Physiotherapy.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9421672589 |
| Fax |
|
| Email |
vrundacharkhapg@mgmiop.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Kapre |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy,
OPD-4, MGM Institute of Physiotherapy.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9425346903 |
| Fax |
|
| Email |
vaibhavkapre@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrunda Charkha |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy,
OPD-4, MGM Institute of Physiotherapy.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9421672589 |
| Fax |
|
| Email |
vrundacharkhapg@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy,N-6 CIDCO, Aurangabad, 431003 MAHARASHTRA India. |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco, Aurangabad, 431003 MAHARASHTRA India. |
| 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 Vrunda Charkha |
MGM Medical College and Hospital |
1. Female Surgery Ward-1
2. Female Surgery Ward-2
3. Male Surgery Ward-1
4. Male Surgery Ward-2
Aurangabad
MAHARASHTRA |
9421672589
vrundacharkhapg@mgmiop.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neurophysiological facilitation of respiration |
Neurophysiological facilitation of respiration includes rhythmic initiation techniques. The patients will be given a rhythmic initiation technique. On the 2nd postoperative day, the patients will receive one session by a physiotherapist giving NPF respiration technique and the treatment consisting of four 15-minute manual stimulations (upper chest wall, lower lateral chest wall, sternum, and lower rib cage/diaphragm). |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 18-60 years.
2. Both males and females included.
3. Both laparotomy and laparoscopic upper
abdominal surgery under general anesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patient on Mechanical ventilation for more
than 48 hours.
2. Hemodynamically unstable patient.
3. Previous cardiac surgery.
4. Infected incisional wound.
5. Chest wall pain.
6. Patients having Rib or Thoracic vertebrae
fracture.
7. Chest wall deformity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Pain will be assessed using a visual analog scale pre- and post- intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Oxygen saturation
2. Respiratory rate
3. Breathing pattern
|
1. Oxygen saturation: oxygen saturation is assessed using a pulse oximeter pre- and post- intervention.
2. Respiratory rate: respiratory rate is assessed by observing chest movement pre- and post- intervention.
3. Breathing pattern: The breathing pattern is assessed using manual assessment of respiratory motion pre- and post- intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vrundacharkhapg@mgmiop.edu.in].
- For how long will this data be available start date provided 30-04-2025 and end date provided 31-07-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients who have undergone upper abdominal surgery will be included in the study trial if they meet the inclusion criteria. The written and oral consent of all patients will be obtained, and the procedure will be explained. Demographic data will be noted. Baseline data, which include pain, oxygen saturation, respiratory rate, and breathing pattern, will be assessed. The Patients will be given a rhythmic initiation technique. On the second postoperative day, the patients will receive one session by a physiotherapist, giving NPF of respiration technique and the treatment consisting of four 15-minute manual stimulations (upper chest wall, lower lateral chest wall, sternum, and lower rib cage/diaphragm). The pressure will be maintained for 10 seconds. Ten repetitions will be given in two sets with a rest period of 1 minute. Pain, oxygen saturation, respiratory rate, and breathing pattern will be assessed before and after the session. We will assess safety by collecting information about any adverse events experienced by the patients.
|