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IRCT20260122068638N1 IRCT 2026-02-25 The University of khomein "Investigating the Effects of Diaphragmatic Breathing Training on Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy " "Investigating the Effects of Diaphragmatic Breathing Training on Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy " 2026-01-29 anticipated 62 Complete https://irct.ir/trial/88722 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study is based on block design with a block size of four and distribution of participants as 1:1 and by the sequence produced with RAS. This method ensures that the number of samples in both intervention and control groups always remains balanced during the process of recruiting patients. The random allocation sequence will be generated by an independent researcher who has no involvement in the recruitment, training, or assessment of patients, and this sequence will be placed in opaque, sealed, and numbered envelopes. When each patient enters, the envelope corresponding to the sequence number is opened and the patient is assigned to the intervention or control group based on the code inside, Blinding description: Due to the open nature of the intervention (breathing exercise), complete blinding of the participants and trainer is not possible. However, data collectors and statistical analysts will be blinded to group allocation to minimize the risk of bias. N/A gastrointestinal Cancer. Intervention 1: Intervention group: The research intervention in the experimental group includes training and implementation of diaphragmatic breathing exercises. Initial training will be conducted in person and face-to-face by the researcher, and an educational brochure, video, and audio file will be provided to the patients to reinforce learning. Each training session will last 10 minutes, and patients will be required to perform it twice a day (9 am and 9 pm) for 14 consecutive days. The first training session will be conducted under the supervision of the researcher to ensure that the patient has learned the method correctly. Then, the patients will continue the exercises independently, and their adherence will be monitored through daily records and telephone calls. Intervention 2: Control group: They will only receive routine oncology care and will not receive any specific breathing training or exercises. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Hannie varvani
banoo street
Arak Iran (Islamic Republic of) 381868764 +98 86 3366 6085 hannnievarvani@gmail.com The University of khomein scientific Hannie varvani
banoo street
Arak Iran (Islamic Republic of) 3818648764 0098863366085 hannievarvani@gmail.com The University of Khomein Iran (Islamic Republic of) Patients will be eligible to enter the research if the definitive diagnosis of digestive tract cancer is registered in their medical records and confirmed by a specialist doctor The age of the patients should be between 18 and 65 years, so that they are physiologically within the range that can be expected to respond to breathing exercises Patients must have a sufficient level of consciousness and cognitive ability to understand the instructions and perform the breathing exercises correctly Fluency in Persian language is required to complete the questionnaires and answer accurately Willingness and written informed consent to cooperate in research Patients must have completed at least one course of chemotherapy so that their clinical conditions are relatively stable 18 years 65 years Both Patients who are unable to participate in this study due to clinical conditions or individual characteristics will not be included in the inclusion group. This category includes patients who have severe heart or lung diseases, and this condition can prevent breathing exercises safely. Patients with a history of severe psychiatric disorders such as diagnosed severe depression or anxiety, or those dependent on sedatives, hypnotics, or addictive substances, will not be eligible for entry. Patients with cognitive or physical limitations that prevent them from performing exercises or completing questionnaires will not be included in the study from the beginning due to ethical and scientific considerations. C15-C26 Malignant neoplasms of digestive organs N/A N/A Intervention group: The research intervention in the experimental group includes training and implementation of diaphragmatic breathing exercises. Initial training will be conducted in person and face-to-face by the researcher, and an educational brochure, video, and audio file will be provided to the patients to reinforce learning. Each training session will last 10 minutes, and patients will be required to perform it twice a day (9 am and 9 pm) for 14 consecutive days. The first training session will be conducted under the supervision of the researcher to ensure that the patient has learned the method correctly. Then, the patients will continue the exercises independently, and their adherence will be monitored through daily records and telephone calls. Control group: They will only receive routine oncology care and will not receive any specific breathing training or exercises. Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy. Timepoint: At the beginning of the study (before the intervention) and 14 days after the start of diaphragmatic breathing. Method of measurement: Pittsburgh Sleep Quality Index-State-Trait Anxiety Inventory. -- --- The University of khomein Approved 2026-01-11 Ethics committee of khomein University of Medical Sciences Arak.,qods blvd.,banoo street.,ensaf8 alley Arak Markazi Iran (Islamic Republic of)