Incentive Spirometry With and Without Transcutaneous Electric Diaphragmatic Stimulation in Post-mastectomy Patients

Breast Cancer, Post-Mastectomy

Mastectomy, Post-Mastectomy, Incentive Spirometer, Transcutaneous Electrical Diaphragmatic Stimulation

This randomized clinical trial will compare the effects of incentive spirometer therapy with and without transcutaneous electrical diaphragmatic stimulation (TEDS) in females who have undergone mastectomy. The study will include females aged 30 to 48 years who have undergone unilateral simple or radical mastectomy following breast cancer and are at least 3 months after surgery. Participants will be randomly assigned to one of two treatment groups. Participants in one group will receive conventional physiotherapy along with transcutaneous electrical diaphragmatic stimulation and incentive spirometer training. Participants in the other group will receive conventional physiotherapy and incentive spirometer training without TEDS. Treatment will be provided over 4 weeks. The study will evaluate changes in breathing-related symptoms, functional capacity, lung function, and quality of life. These outcomes will be assessed using a dyspnea index, Timed Up and Go test, pulmonary function testing (spirometry), and the Short Form-36 health survey. Assessments will be performed at baseline and after 4 weeks of treatment. The study aims to determine whether adding transcutaneous electrical diaphragmatic stimulation to incentive spirometer therapy provides additional benefits for post-mastectomy females.

Mastectomy is a surgical procedure used in the management of breast cancer. Following mastectomy, patients may experience changes in respiratory function, breathing patterns, functional capacity, and quality of life. This study will compare incentive spirometer therapy with and without transcutaneous electrical diaphragmatic stimulation (TEDS) in females following mastectomy. This study is designed as a randomized clinical trial. Participants will be recruited from Pink Ribbon Hospital and randomly allocated to two treatment groups using sealed-envelope randomization. The study will include females aged 30 to 48 years who have undergone unilateral simple or radical mastectomy, have a history of stage I to III breast cancer, are at least 3 months post-surgery, and have received chemotherapy or radiotherapy. Participants in Group A will receive conventional physiotherapy, transcutaneous electrical diaphragmatic stimulation, and incentive spirometer training. TEDS will be applied using surface electrodes placed over the lower rib cage. The intervention will be delivered using an electrical stimulation unit, with intensity adjusted to produce a visible or palpable diaphragmatic contraction without discomfort. Participants will also perform incentive spirometer exercises. Participants in Group B will receive conventional physiotherapy and incentive spirometer training without TEDS. Conventional physiotherapy will include diaphragmatic breathing, airway clearance exercises, circulatory exercises, thoracic expansion exercises, and postural awareness exercises. Treatment will be provided four times per week for 4 weeks. The primary areas of assessment will include dyspnea, functional capacity, pulmonary function, and quality of life. Dyspnea will be assessed using a 5-point Likert-based dyspnea index. Functional capacity will be assessed using the Timed Up and Go test. Pulmonary function will be assessed using spirometry, including measurements of forced vital capacity and expiratory volume. Quality of life will be assessed using the Short Form-36 questionnaire. Outcome assessments will be conducted at baseline and at the fourth week of the intervention. The study will evaluate whether adding TEDS to incentive spirometer therapy produces greater improvements in the measured outcomes compared with incentive spirometer therapy and conventional physiotherapy alone. The study protocol specifies a randomized allocation procedure using sealed envelopes and a single-blinded outcome assessment, in which the assessor is blinded to group allocation.

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