| CTRI Number |
CTRI/2024/08/072519 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comprehensive Intervention ] |
| Study Design |
Other |
|
Public Title of Study
|
early Rehabilitation program for post mastectomy patients |
|
Scientific Title of Study
|
effectiveness of comprehensive intervention on range of motion, muscle strength and health related quality of life among post mastectomy patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angita |
| Designation |
PG Student |
| Affiliation |
All India Institute of medical sciences Bhopal |
| Address |
Department medical surgical(oncology) Nursing
College of Nursing
All India Institute of Medical Sciences
Bhopal
MP
462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7876314365 |
| Fax |
|
| Email |
angitathakur239@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jisa George T |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUITE OF MEDICAL SCIENCES BHOPAL |
| Address |
Department of Medical Surgical(oncology) Nursing
College of Nursing
All India Institute of Medical Sciences
Bhopal
MP
462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9496493473 |
| Fax |
|
| Email |
jisagt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Angita |
| Designation |
PG student |
| Affiliation |
ALL INDIA INSTITUITE OF MEDICAL SCIENCES BHOPAL |
| Address |
Department of Medical surgical(Oncology) Nursing
College of Nursing
All India Institute of Medical Sciences
Bhopal
MP
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
07876314365 |
| Fax |
|
| Email |
angitathakur239@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India
462020
|
|
|
Primary Sponsor
|
| Name |
Angita |
| Address |
Department of Medical Surgical(Oncology) Nursing
College of Nursing
All India Institute of Medical Sciences
Bhopal
MP
462020 |
| 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 |
| Dr Jisa George T |
All India Instituite od Medical Sciences Bhopal |
Department of Medical Surgical(oncology) Nursing
College of Nursing
All India Institute of medical sciences
Bhopal
Madhya Pradesh
462020
Bhopal
MADHYA PRADESH |
9947091812
jisagt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics CommitteeStudent Research(IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Intervention |
Comprehensive intervention: In
the present study
Comprehensive Intervention
comprises of Multi Component
Interventions that include:- 1.
Supervised Physical Therapy
2.educational Strategies 3.
Multimedia Instructional
package. 1. Supervised
Physical Therapy:- deep
breathing, chest wall stretch,
shoulder stretch, cross body
reach, pendulum stretch, finger
wall walk, inward and outward
rotation. 2. Educational
Strategies:- information booklet
that include home Management
like exercise at Home, Diet,
Psychological Health benefits,
Rest and Sleep, Yoga,
Meditation, Promotion of Self
Esteem and Discharge
Teaching. 3. Multimedia Instructional Package: - it
includes Video-Assisted
Demonstration on Post
Mastectomy Exercises.
|
| Comparator Agent |
Routine care |
Pharmacological treatment by
the concerned doctor, Nursing care by the ward staff that include Medication administration, Maintenance of Intake output, maintenance of feeding. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria
 Post mastectomy female patients, Patients who were willing to participate, Patients present at the time of data collection, Patients with age more than 18 years.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria, Patients with musculoskeletal problems of upper extremity, Patients with cognitive impairment who are not able to follow the commands.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improving range of motion among post
mastectomy
2. strengthening muscle strength among post
mastectomy
3. health related quality of life among post
mastectomy |
baseline/pre intervention Assessment - 2nd Post
operative Day
1st Post intervention assessment - 5th Post
Operative Day
2nd Post Intervention Assessment- 14th Post
Operative Day
3rd Post Intervention Assessment- 30th Post
Operative Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early Recovery of the Patient after Mastectomy and less hospital stay duration. |
5th, 14th & 30th Post Operative Day after
Mastectomy |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="0"
Months="1"
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
|
As per WHO report in 2020, there were 2.3 million women diagnosed with breast cancer and 685 000 deaths globally.In India Breast Cancer accounted for 27.7% newly diagnosed cancer among women, which roughly says that every one in four newly diagnosed cancer among women in India was breast cancer.Mastectomy is breast cancer surgery that removes the entire breast. There are several different types of mastectomies, based on how the surgery is done and how much tissue is removed like simple or total mastectomy, modified radical mastectomy, radical mastectomy, skin sparing mastectomy. Most women should be fairly functional after going home and can often return to their regular activities within about 4 weeks after surgery. Recovery time is longer if breast reconstruction was also done.Possible complications after mastectomy would be thromboembolism, Wound infection, Bleeding, Fluid collecting around the operation site (seroma), Blood collecting around the operation site (hematoma), Shoulder stiffness, lymphoedema, Scar tissue in the armpit (cording).Postmastectomy management includes care related to resuming activity, Regaining Range of Motion, Lymphedema Prevention, scar management and scar massage.Nursing care after mastectomy include Relieving Pain and Discomfort, Managing sensations, Coping with body image, preventing Post Mastectomy Complications. Mastectomy can leads to potential complications which include pain, impaired range of motion, deterioration of quality of life and also long term complication like lymphedema can also occur if not managed early among people which can be treated with comprehensive nursing care that include exercise therapy, health education. There are so many studies conducted which have proved that nursing care after mastectomy is helpful in preventing post mastectomy complications. There are few studies which have been conducted in India also but as this kind of study is not yet done in central India, so that it’s an opportunity for doing this study for better implication of oncology nursing care in health care settings and in the prevention of post mastectomy complications. |