]>
IRCT20231212060343N1 IRCT 2024-01-23 Qazvin University of Medical Sciences The impact of pranayama breathing exercises on the symptom burden of breast cancer Comparison of the effect of pranayama breathing exercise and conventional treatment on symptom burden in women with breast cancer undergoing chemotherapy 2024-01-21 anticipated 76 Complete https://irct.ir/trial/74472 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be divided into two groups: test and control. This allocation will be achieved through random block allocation. Blocking and sequencing of samples will be conducted using random allocation software (Random Allocation Software, Version 1.0.0). To maintain the confidentiality of the random allocation process, group names will be placed inside numbered envelopes. These envelopes will be numbered in sequence by the software and organized in a box. The researcher responsible for random allocation will remain unaware of the envelope contents. Each envelope will denote the assigned study group (intervention or control). Once the sample is confirmed to have entered the research and written consent is obtained, the first envelope will be numbered. Based on its contents, the envelope will assign the participant to one of the study groups, Blinding description: To maintain blinding, a collaborating researcher, unaware of patient allocation to control and intervention groups, will complete the questionnaires. 3 Breast Cancer. Intervention 1: In the intervention group, the researcher will guide patients through pranayama breathing exercises step by step during the initial face-to-face meeting in the clinic, which occurs before the commencement of chemotherapy. Group interventions, involving 3 to 5 participants, will take place for 15 to 20 minutes in a quiet and peaceful room within the chemotherapy department. Patients, and any accompanying companions, will be instructed, and video materials will be provided for additional support. Participants are expected to practice breathing exercises at home for 10 minutes twice a day over 21 days, starting one week before the initiation of chemotherapy until the 14th day after its commencement. The researcher will conduct daily phone calls to ensure participants are adhering to the home-based exercises and to monitor their health status. A diary will be designed in table format to record the time of each patient's breathing exercise, along with the frequency and type performed during the 21 days. Kapalabati and Nadi Shavana breathing exercises will be implemented in this study. Intervention 2: Control group: Breast cancer patients undergoing chemotherapy will receive routine treatment. Yes - There is a plan to make this available What will be shared: Undecided - It is not yet known if there will be a plan to make this available When: Undecided - It is not yet known if there will be a plan to make this available To whom: Undecided - It is not yet known if there will be a plan to make this available Conditions: Undecided - It is not yet known if there will be a plan to make this available Where to obtain: Undecided - It is not yet known if there will be a plan to make this available How to obtain: Undecided - It is not yet known if there will be a plan to make this available Comments: Undecided - It is not yet known if there will be a plan to make this available
public Sima Mohebbi
Shahid Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 15315-34199 +98 28 3333 9569 sima.mohebbi6859@gmail.com Qazvin University of Medical Sciences scientific Sima Mohebbi
Shahid Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 15315-34199 +98 28 3332 4970 sima.mohebbi6859@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of breast cancer (new cases) Women 18 years and older Passing at least one cycle of chemotherapy Patients with stage one to three breast cancer Patients who have undergone chemotherapy after breast surgery Being literate in reading and writing Willingness to participate in the study Having a performance scale of 0 to 2 18 years no limit Female Simultaneously suffering from other diseases (heart diseases, respiratory diseases, liver diseases, etc.) Radiotherapy at the same time Concomitant pregnancy or breastfeeding History of mental illness or psychotropic drug use C50 Malignant neoplasm of breast Rehabilitation Rehabilitation In the intervention group, the researcher will guide patients through pranayama breathing exercises step by step during the initial face-to-face meeting in the clinic, which occurs before the commencement of chemotherapy. Group interventions, involving 3 to 5 participants, will take place for 15 to 20 minutes in a quiet and peaceful room within the chemotherapy department. Patients, and any accompanying companions, will be instructed, and video materials will be provided for additional support. Participants are expected to practice breathing exercises at home for 10 minutes twice a day over 21 days, starting one week before the initiation of chemotherapy until the 14th day after its commencement. The researcher will conduct daily phone calls to ensure participants are adhering to the home-based exercises and to monitor their health status. A diary will be designed in table format to record the time of each patient's breathing exercise, along with the frequency and type performed during the 21 days. Kapalabati and Nadi Shavana breathing exercises will be implemented in this study. Control group: Breast cancer patients undergoing chemotherapy will receive routine treatment. Symptom burden. Timepoint: Before and after intervention. Method of measurement: Eastern cooperative oncology group performance status rating (ECOG) and (M. D. Anderson Symptom Inventory (MDASI). Qazvin University of Medical Sciences Approved 2023-12-11 Research Ethics Committees of Qazvin University of Medical Sciences University of Medical Sciences Headquarters, Building No. 1, Office Complex, Shahid Salmani St., North Nawab St., Qazvin. Qazvin Qazvin Iran (Islamic Republic of)