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IRCT20260217068900N1 IRCT 2026-07-20 Shahid Beheshti University of Medical Sciences The comparative effect of online and nurse led support self-care modules on clinical outcomes among patients undergoing open heart surgery The comparative effect of online and nurse led support self-care modules on clinical outcomes among patients undergoing open heart surgery 2026-08-21 anticipated 52 Recruiting https://irct.ir/trial/89275 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Patients undergoing open‑heart surgery often experience a wide range of physical and psychological symptoms, which may potentially be associated with a reduced quality of life. By improving self‑care ability, the quality of life of cardiac patients can be enhanced. Nurse‑led interventions, through active nurse involvement and disease management, lead to reduced hospital readmission rates among cardiac patients, decreased mortality, reduced burden on healthcare systems, improved integrated management of chronic diseases, and enhanced self‑care skills. Educational interventions can increase patients’ knowledge about self‑care and influence their capacity to perform self‑care behaviors. The use of self‑care modules is a novel educational approach that has been introduced into clinical education within the past decade. In this study, we aim to investigate the effects of implementing self‑care module‑based interventions delivered through online and nurse‑led methods on post–cardiac surgery clinical outcomes, including quality of life, self‑efficacy, and treatment adherence in patients after cardiac surgery, Randomization description: Samples will first be selected through convenience sampling and then randomly block‑allocated into two groups: distance (online) education and face‑to‑face education. Using randomized blocks of four and prepared envelopes, each patient will be assigned a random code according to the order in which they enter the study, and patients will be placed into the two groups based on these random codes. Considering that sampling will take place in two hospitals and to prevent contamination of the samples, one hospital will be randomly assigned to the online education group and the other to the nurse‑led (face‑to‑face) education group. Then, according to the four‑person blocks, each patient will be randomly assigned to group A (online intervention) or group B (in‑person intervention). For example, after randomly selecting a block such as BABA, patients will be assigned in the following order: online, in‑person, online, in‑person; and for the next block, such as AABB, patients will be assigned online, online, in‑person, in‑person. The number of individuals allocated to each group will be approximately equal. In this study, in addition to random allocation, allocation concealment was also performed. For this purpose, first, the random sequence was generated. Then, based on the study sample size, a number of envelopes were prepared, and each random sequence was recorded on a card, which was then placed inside an envelope in order. To preserve the random sequence, the envelopes were numbered externally in the same order. Finally, the envelopes were sealed and placed inside a box in sequence. At the time of participant registration, and according to the order in which eligible participants entered the study, one envelope was opened each time, revealing the group assigned to that participant. Individuals were assigned to the intended group based on their order of entry into the study and the randomized block sequences, Blinding description: Given that sampling will be conducted in two hospitals, in order to prevent contamination between samples, one hospital will be randomly assigned to the online education group and the other hospital to the nurse‑led education group. N/A nurse led support- self-care- modules - open heart surgery- online education. Intervention 1: Intervention group 1: Online self-care modules (text, audio, and video) delivered via a messaging platform from one day before surgery until 4 weeks after discharge.Intervention group 2: Nurse-led self-care modules with identical educational content delivered in four 45-minute face-to-face sessions during hospitalization, followed by telephone follow-up for 4 weeks after discharge. Intervention 2: Evaluating the effect of nurse‑led self‑care modules on the clinical outcomes of patients undergoing open‑heart surgery. Yes - There is a plan to make this available What will be shared: all datails When: 2027 To whom: everyone Conditions: any condition Where to obtain: author How to obtain: nothing Comments:
public Dr.Neda Sanaie
**Tehran, Valiasr Street, intersection with Ayatollah Hashemi Rafsanjani Highway, opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery.**
Tehran Iran (Islamic Republic of) 1996835119 02188655366-70 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences scientific Dr.Neda Sanaie
Tehran, Valiasr Street, intersection with Ayatollah Hashemi Rafsanjani Highway, opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery.
Tehran Iran (Islamic Republic of) 1996835119 88655366-337 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18 and 65 years Patients undergoing coronary artery bypass graft surgery for the first time Not an emergency surgery Not being in a critical or emergency condition At least 24 hours have passed since the patient’s admission Not having a debilitating disease No impairment in speech, hearing, or vision and able to communicate and cooperate Not suffering from any known physical or mental illnesses that significantly affect quality of life, such as being on dialysis or other recognized psychological conditions (e.g., depression or schizophrenia) that require specific medications or regimens (based on patient self-report) Access to a smartphone capable of installing a messaging app 18 years 65 years Both Individuals who have participated in another training program during the study period Individuals who require readmission due to entering the acute phase of the illness Withdrawal from participation in the study Failure to respond to all questionnaire items (incomplete questionnaires) Individuals who are absent from two or more of the total follow-up sessions Transfer from the research unit to another unit Rehabilitation Rehabilitation Intervention group 1: Online self-care modules (text, audio, and video) delivered via a messaging platform from one day before surgery until 4 weeks after discharge.Intervention group 2: Nurse-led self-care modules with identical educational content delivered in four 45-minute face-to-face sessions during hospitalization, followed by telephone follow-up for 4 weeks after discharge. Evaluating the effect of nurse‑led self‑care modules on the clinical outcomes of patients undergoing open‑heart surgery. Treatment adherence. Timepoint: At entry into the study and eight weeks after completion of the intervention. Method of measurement: Medanlou Treatment Adherence Questionnaire. Self‑efficacy. Timepoint: At entry into the study and eight weeks after completion of the intervention. Method of measurement: Cardiac Self‑Efficacy Scale (STECA). Health‑related quality of life. Timepoint: At entry into the study and eight weeks after completion of the intervention. Method of measurement: World Health Organization Quality of Life – Brief Questionnaire(WHOQOL-BREF). Shahid Beheshti University of Medical Sciences Approved 2026-02-15 The Ethics Committee of the Schools of Pharmacy, Nursing, and Midwifery – Shahid Beheshti University School of Nursing and Midwifery, across from Shahid Rajaei Heart Hospital, intersection of Vali‑Asr Street and Ayatollah Hashemi Rafsanjani Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)