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IRCT20200302046662N1 IRCT 2020-03-07 Shiraz University of Medical Sciences Investigation of the effect of cardiac rehabilitation on patients with different types of heart rhythm management devices and their spouses Investigation of the effect of cardiac rehabilitation via telenursing on sexual satisfaction and fatigue of patients with different types of heart rhythm management devices and their spouses at arrhythmias clinics affiliated to Shiraz University of Medical Sciences 2020-05-21 anticipated 68 Complete https://irct.ir/trial/46285 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present study will be conducted on couples and patients' spouses will be included.Therefore, the intervention group (34 patients plus 34 spouses) and the control group (34 patients plus 34 spouses) will total 68 couples (136 persons), Randomization description: Using the stratified random sampling method, here are the classes of Cardiac resynchronization therapy, implantable cardiac defibrillator and pacemaker to fit each class, 14 patients with Cardiac resynchronization therapy, 22 patients with implantable cardiac defibrillator and 32 patients with Pacemakers will first be selected as available sampling in the aforementioned classes, and then random allocation using Random allocation Software to generate block randomization lists of each block size 2 or 4 2 blocks of 7, floor implantable cardioverter defibrillator The size of 2 blocks of 11 blocks and the pacemaker class 4 blocks of 8 blocks will be divided into control and patient groups, Blinding description: In order to single blind , questionnaires will be collected by the first researcher and assigned to intervention and control groups by the second researcher, so the outcome assessor will be kept blind. Also, the person analyzing the data will not be aware of the intervention and control groups. N/A Condition 1: Patients with different types of heart rhythm management devices. Condition 2: Spouses of patients with different types of heart rhythm management devices. Intervention 1: Intervention group: Intervention group (patient plus his / her spouse) during an 8-week period including 8 sessions of cardiac rehabilitation: 2 in-person sessions including training and counseling on fatigue and sexual satisfaction for two weeks (one session per week) and after in-person sessions starting with the third week of the intervention, 6 non-face-to-face sessions will be followed by 6-week telephone follow_ups (one call per week by the nurse). Also, educational-motivational text messages will be sent three times a week from the beginning of the rehabilitation period. Patients will perform exercise sessions at home according to the cardiac electrophysiology practitioner and based on the instruction booklet we will provide. Intervention 2: Control group: There is no intervention, and patients will receive only routine training and routine care. 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"
public Mahnaz Rakhshan
Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi Hospital, Namazi Square
Shiraz Iran (Islamic Republic of) ۱۳۱۱۹ - ۷۱۹۳۶ 0098 7136474254-8 rakhshanm@sums.ac.ir Shiraz University of Medical Sciences scientific Mahnaz Rakhshan
Fatemeh (P.B.U.H) School of Nursing and Midwifery, Namazi Hospital, Namazi Square
Shiraz Iran (Islamic Republic of) ۱۳۱۱۹ - ۷۱۹۳۶ 0098 7136474254-8 rakhshanm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Has one of a different types of heart rhythm management devices and has been implanted for at least three months Be married Only have one spouse 18 to 70 years old Not diagnosed mental illness and acute cognitive disorders Not having severe orthopedic, neurological, visual and hearing problems Ability to understand and speak and read and write Persian language Phone access (fixed and mobile) after discharge Have sexual activity 18 years 70 years Both Incidence of unstable angina Uncontrolled blood pressure, resting systole greater than 180 mmHg or diastolic resting time greater than 110 mmHg Severe neurological, orthopedic and musculoskeletal problems that occur during the study and prevent them from being active The patient's unwillingness to continue attending the study Not attending one of the pre- or post-test sessions Not attending one of the in person sessions Rehabilitation Treatment - Drugs Intervention group: Intervention group (patient plus his / her spouse) during an 8-week period including 8 sessions of cardiac rehabilitation: 2 in-person sessions including training and counseling on fatigue and sexual satisfaction for two weeks (one session per week) and after in-person sessions starting with the third week of the intervention, 6 non-face-to-face sessions will be followed by 6-week telephone follow_ups (one call per week by the nurse). Also, educational-motivational text messages will be sent three times a week from the beginning of the rehabilitation period. Patients will perform exercise sessions at home according to the cardiac electrophysiology practitioner and based on the instruction booklet we will provide. Control group: There is no intervention, and patients will receive only routine training and routine care. Level of sexual satisfaction in Hudson Index of Sexual Satisfaction questionnaire. Timepoint: At baseline (before intervention) and 2 months after intervention. Method of measurement: Hudson Index of Sexual Satisfaction. Fatigue score on the Fatigue Severity Scale Questionnaire. Timepoint: At baseline (before intervention) and 2 months after intervention. Method of measurement: Fatigue Severity Scale. Shiraz University of Medical Sciences Approved 2020-01-15 Ethics committee of Shiraz University of Medical Sciences Fatemeh(P.B.U.H)School of Nursing and Midwifery, Namazi Hospital, Namazi Square Shiraz Fars Iran (Islamic Republic of)