| CTRI Number |
CTRI/2024/07/071215 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Multimodal Nursing Interventation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of nursing intervention to enhance quality of life among burn patient. |
|
Scientific Title of Study
|
Effect of multimodal nursing intervention on selected health related clinical outcome among burn patient. admitted in IMS and SUM Hospital, Bhubaneswar. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Jhunilata Pradhan |
| Designation |
Associate Professor |
| Affiliation |
Sum Nursing College, Siksha O Anusandhan University, Campus-2, K-8, Kalinga nagara, Bhubaneswar |
| Address |
Room NO- 4,Second Floor, Dept. of Medical Surgical Nursing, Sum Nursing College,Siksha O
Anusandhan University, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
9861566390 |
| Fax |
|
| Email |
jhunilatapradhan@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Jhunilata Pradhan |
| Designation |
Associate Professor |
| Affiliation |
Sum Nursing College, Siksha O Anusandhan University, Campus-2, K-8, Kalinga nagara, Bhubaneswar |
| Address |
Room NO- 4,Second Floor, Dept. of Medical Surgical Nursing, Sum Nursing College,Siksha O
Anusandhan University, Bhubaneswar.
ORISSA
751003
India |
| Phone |
9861566390 |
| Fax |
|
| Email |
jhunilatapradhan@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
ProfDrSasmita Das |
| Designation |
Associate Dean |
| Affiliation |
Sum Nursing College, Siksha O Anusandhan University, Campus-2, K-8, Kalinga Nagar, Bhubaneswar |
| Address |
Ground Floor, Dept. of Medical Surgical Nursing, Sum Nursing College,Siksha O
Anusandhan University, Bhubaneswar.
Khordha
ORISSA
751003
India |
| Phone |
9861566390 |
| Fax |
|
| Email |
das.sasmita2@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUM Nursing College, Siksha O Anushandhan University,Kalinga Nagar, Ghatikia, Bhubanswar, Odisha, India, Pin-751003 |
|
|
Primary Sponsor
|
| Name |
Ms.Jhunilata Pradhan. |
| Address |
SUM Nursing College, Campus-2, K-8, Kainganagar, Bhubaneswar,
751003
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof Dr Sasmita Das |
Institute Of Medical Science & SUM Hospital |
Burn and Plastic Surgery Unit,Third Floor, IMS &
SUM Hospital, K-8,
Kalinga Nagar, Ghatikia
Bhubaneswar,
751003
Khordha
ORISSA |
9776645936
das.sasmita2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS and SUM Hospital. Bhubaneswar. Odisha. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal Nursing Interventation. |
INTERVENTION
Session 1
. Introducing the researcher, the objectives, and content of the sessions to the participants. Application of Burn Specific Health Scale BSHS-B, General Self Efficacy Scale (GSES), Pittsburgh Sleep Quality Index (PSQI) and Becks Depression Inventory (BDI)
Session 2
Deep breathing exercise will be given twice in a day for 5 mins for each cycle then followed by meditation for 5 mins. Burn part specific ROM and muscle stretching exercise for 15 minutes.
Session 3
Deep breathing exercise will be given twice in a day for 5 mins for each cycle then followed by meditation for 5 mins. Burn part specific ROM and muscle stretching exercise for 15 minutes. Educational and motivational talk to manage mental health and emotional enhancement
Session 4
Deep breathing exercise will be given twice in a day for 5 mins for each cycle then followed by meditation for 5 mins. Burn part specific ROM and muscle stretching exercise for 15 minutes.
Session 5
Deep breathing exercise will be given twice in a day for 5 mins for each cycle then followed by meditation for 5 mins. Burn part specific ROM and muscle stretching exercise for 15 minutes. Sharing experience of burn survivor through video.
Session 6
Deep breathing exercise will be given twice in a day for 5 mins for each cycle then followed by meditation for 5 mins. Burn part specific ROM and muscle stretching exercise for 15 minutes.
Session-7
Deep breathing exercise will be given twice in a day for 5 mins for each cycle then followed by meditation for 5 mins. Burn part specific ROM and muscle stretching exercise for 15 minutes. Demonstration and education of care of burn wound, importance of nutrition and self-care management.
Session-8-14
Repeat the intervention of Session-2 to Session-7
Session-15
A review of the discussed points, receiving feedback from the members regarding the discussed points, question and answer, discussion
Session-16
Self-performance of the activities by the study participants observed by the researcher.
Posttest will be conduct at the time of discharge.
|
| Comparator Agent |
Multimodal Nursing Interventions. |
the control group will receive the standard treatment with counselling. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patient age 20yrs-60yrs
2. Patient able to communicate
3. Burn with surface area less than 30%
4. Burn injury with grade 1, 2 & 3.
|
|
| ExclusionCriteria |
| Details |
1. Who are unconscious.
2. Airway injury due to burn
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related clinical outcome |
date of admission up to 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Burn Specific Quality of Life,Level of sleep, Self efficacy and Level of depression. |
Date of admission up to 6 months. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
07/08/2024 |
| 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 - NO
|
|
Brief Summary
|
Burn is an unforeseen event that constitutes a physical as well as a psychological trauma for the affected person. Globally burns are one of the major causes of disability, with more than8 millions disability adjusted life years.(DALYs). Burn patients may have a greater risk of developing poor quality of life, depression, decrease level of self efficacy and quality of sleep. This condition may continue a long term with the patient.so it is important for the patient to maintain and promote the physical and mental health including the related factors along with the medical management. 1. H01- There is no significant difference between post score of experimental and control group in terms of quality of life, level of sleep, self efficacy and level of depression 2. H02- There is no significant changes in terms of quality of life, level of sleep, self efficacy and level of depression before and after receiving intervention. |