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Clinical Trials/CTRI/2024/08/072519
CTRI/2024/08/072519Not yet recruitingNot Applicable

effectiveness of comprehensive intervention on range of motion, muscle strength and health related quality of life among post mastectomy patients

Angita1 site in 1 country40 target enrollmentStarted: August 30, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
improving range of motion among post

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

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.

Exclusion Criteria

  • , Patients with musculoskeletal problems of upper extremity, Patients with cognitive impairment who are not able to follow the commands.

Outcomes

Primary Outcomes

improving range of motion among post

Time Frame: 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

mastectomy

Time Frame: 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

2. strengthening muscle strength among post

Time Frame: 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

3. health related quality of life among post

Time Frame: 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 Outcomes

  • Early Recovery of the Patient after Mastectomy and less hospital stay duration.(5th, 14th & 30th Post Operative Day after)

Investigators

Sponsor
Angita
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Angita

All India Institute of medical sciences Bhopal

Study Sites (1)

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