]>
IRCT20240712062397N1 IRCT 2024-08-01 Islamic Azad University Investigating the Efficacy of Cognitive-Behavioral Stress Management Training in Breast Cancer Patients Efficacy of Cognitive-Behavioral Stress Management Training on Pain Self-Efficacy, Quality of Life, Psychological Well-being, and Fear of Body Image in Women with Breast Cancer 2023-06-22 anticipated 30 Complete https://irct.ir/trial/77941 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: All the participants in the experimental and control groups are unaware of the implementation process and the expected results of the training and how to be assigned to the groups. N/A Breast cancer. Intervention 1: Intervention Group: The experimental group underwent cognitive-behavioral stress management training based on Michael Anthony's protocol (translated by Safarzadeh and Karami, 2013) in ten 120-minute sessions. They completed questionnaires before, immediately after, and one month after the sessions. Intervention 2: Control Group: The control group did not receive any intervention. They only completed the questionnaires at the same three stages as the experimental group. 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 There is no further information
public Fatemeh Toghani
Islamic Azad University, 7th Kilometer Darya Road (Farah Abad), Khazar Square, Sari, Mazandaran, Iran
Sari Iran (Islamic Republic of) 48164-194 +98 11 3303 2891 fatemetoghani@yahoo.com Islamic Azad University scientific Bahram Mirzaian
Islamic Azad University, 7th Kilometer Darya Road (Farah Abad), Khazar Square, Sari, Mazandaran, Iran
Sari Iran (Islamic Republic of) 48164-194 +98 11 3325 9528 bahrammirzaian@gmail.com Islamic Azad University Iran (Islamic Republic of) Female gender Being between 30-50 years old Non-invasive stage (1-2) of breast cancer Have undergone mastectomy surgery Having informed consent to participate in the study Not having a history of serious psychiatric disorders such as psychosis or similar conditions (based on the initial clinical interview). Not having any other severe physical diseases Not having taken psychiatric medication in the past three months Having minimum education up to a high school diploma 30 years 50 years Female Having more than 2 absences in treatment Recurrence of the disease Suffering from a specific obvious physical disease during the intervention period Having mania or psychotic disorder C50 Malignant neoplasm of breast Other Other Intervention Group: The experimental group underwent cognitive-behavioral stress management training based on Michael Anthony's protocol (translated by Safarzadeh and Karami, 2013) in ten 120-minute sessions. They completed questionnaires before, immediately after, and one month after the sessions. Control Group: The control group did not receive any intervention. They only completed the questionnaires at the same three stages as the experimental group. Pain self-efficacy score in pain self-efficacy questionnaire. Timepoint: In three stages: before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Pain Self-efficacy Questionnaire. The quality of life score in the quality of life questionnaire (WHOQOL-BREF). Timepoint: In three stages: before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: World Health Organization quality of life questionnaire - short form (WHOQOL-BREF). Psychological well-being score in Ryff questionnaire. Timepoint: In three stages: before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Ryff psychological well-being questionnaire (RSPWB-18). Body image fear score in Littleton's questionnaire. Timepoint: In three stages: before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Littleton's Fear of Body Image Questionnaire (BICI). General health score. Timepoint: In three stages: before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Ryff's Psychological well-being and World Health Organization's quality of life questionnaire. Islamic Azad University Approved 2023-04-17 Ethics Committee in Research at Islamic Azad University, Sari Branch Islamic Azad University, Sari Branch, Research Ethics Committee, 7th Kilometer Darya Road (Farah Abad), Khazar Square, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)