| CTRI Number |
CTRI/2025/01/079416 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of supportive communication and Range of motion exercises on critical care pain and complications among ICU admitted patients admitted to Intensive Care Unit |
|
Scientific Title of Study
|
Effectiveness of Nurse-led lnterventions on Specific Clinical Outcomes among patients admitted to Intensive Care Units at tertiary care hospital, Manglore. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghashree Gajanan Naik |
| Designation |
MSc Nursing (Medical Surgical Nursing ) |
| Affiliation |
Yenepoya Nursing College |
| Address |
Dept of Medical Surgical Nursing
Yenepoya Nursing College
Naringana 575018
Mangaluru
Uttara Kannada
KARNATAKA
575018
India |
| Phone |
7019047547 |
| Fax |
|
| Email |
meghashreenaik98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hezil Reema Barboza |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Nursing College |
| Address |
Dept of Nursing Foundation
Yenepoya Nursing College
Naringana
Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
90082 18663 |
| Fax |
|
| Email |
hezilreema@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Meghashree Gajanan Naik |
| Designation |
MSc Nursing (Medical Surgical Nursing ) |
| Affiliation |
Yenepoya Nursing College |
| Address |
Dept of Medical Surgical Nursing
Yenepoya Nursing College
Naringana 575018
Mangaluru
Uttara Kannada
KARNATAKA
575018
India |
| Phone |
7019047547 |
| Fax |
|
| Email |
meghashreenaik98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital
Deralakatte 575018
Dakshina kannada |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Meghashree Gajanan Naik |
Intensive Care Unit, Yenepoya Medical College Hospital |
Yenepoya Medical College Hospital
Deralakatte 575018
Managlore 575018
Dakshina Kannada
KARNATAKA |
7019047547
meghashreenaik98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I238||Other current complications following acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led Interventions which includes supportive communication and Range of Motion Exercises |
Total duration of intervention is for one week.post test will be conducted after one week.
a. Supportive communication:
It includes touch, spending time with the patient and being involved in patient care in the morning for 30 min for one week.
b. Range of motion exercises for upper and lower extremities:
Upper extremity range of motion exercises include flexion and extension of wrist, elbow and shoulder.
Lower extremity range of motion exercises include ankle dorsi flexion and plantar flexion.
All the movements will be performed for 15 min in the evening for one week
|
| Comparator Agent |
Routine nursing care |
Routine Nursing Care |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Conscious and responds to verbal commands
With medical diagnosis of pulmonary and cardiovascular diseases
|
|
| ExclusionCriteria |
| Details |
1. With physical deformities that restrict their ability to perform certain type of exercises
2. Support of mechanical ventilation and aggressive therapies such as BiPAP |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Critical care pain and ICU related complications |
one week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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 Yet Recruiting |
| 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)
|
A quasi experimental study will be conducted to assess the nurse-led interventions including supportive communication and range of motion exercises for upper and lower extremities on specific clinical outcomes such as critical care pain and ICU-related complications among patients admitted to the Intensive Care Unit. Supportive communication which includes touch, spending time with the patient and being involved in patient care. Range of motion exercises will be performed for the upper and lower extremities. Upper extremity range of motion exercises include flexion and extension of wrist, elbow and shoulder. Lower extremity range of motion exercises include ankle dorsi flexion and plantar flexion. Pretest will be performed before providing interventions with routine treatment in the group and control group. Posttest will be conducted after 2 days of intervention and on the day of discharge from the ICU. |