Protocol summary

Study aim
To determine the comparative effect of online and nurse-led self-care support modules on clinical outcomes in patients undergoing open-heart surgery.
Design
In the first phase of the study, the content of the self-care modules for cardiac surgery will be developed. In the second phase, participants will be selected by convenience sampling. In the nurse-led education group, all educational content will be provided through face-to-face individual and group oral instruction with accompanying written materials, delivered in person by the researcher during hospitalization and after ICU discharge. After discharge, follow-up will be conducted by telephone. Eight weeks after the completion of the intervention, the questionnaires will be re-administered and the data will be analyzed.
Settings and conduct
In the online education group, the self‑care modules will be delivered through a platform agreed upon by the participants, starting from the day before surgery and continuing until eight weeks after discharge. In the nurse‑led education group, training will be provided verbally, face‑to‑face, and in written form during hospitalization, and will continue by telephone for up to eight weeks after discharge. .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 18 and 65 years Patients undergoing coronary artery bypass graft surgery for the first time Not an emergency surgery
Intervention groups
In this study, we aim to investigate the effect of implementing interventions based on self-care modules delivered online and nurse-led on post-operative clinical outcomes in cardiac surgery patients, including quality of life, self-efficacy, and treatment adherence.
Main outcome variables
Quality of life scores of patients undergoing open‑heart surgery Treatment adherence scores of patients undergoing open‑heart surgery Self‑efficacy scores of patients undergoing open‑heart surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260217068900N1
Registration date: 2026-07-20, 1405/04/29
Registration timing: prospective

Last update: 2026-07-20, 1405/04/29
Update count: 0
Registration date
2026-07-20, 1405/04/29
Registrant information
Name
Amirhosein Madadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3615 2401
Email address
amirmadadi1396@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-21, 1405/05/30
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of online and nurse led support self-care modules on clinical outcomes among patients undergoing open heart surgery
Public title
The comparative effect of online and nurse led support self-care modules on clinical outcomes among patients undergoing open heart surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Schools of Pharmacy, Nursing, and Midwifery – Shahid Beheshti University
Street address
School of Nursing and Midwifery, across from Shahid Rajaei Heart Hospital, intersection of Vali‑Asr Street and Ayatollah Hashemi Rafsanjani Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2026-02-15, 1404/11/26
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1404.257

Health conditions studied

1

Description of health condition studied
nurse led support- self-care- modules - open heart surgery- online education
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Treatment adherence
Timepoint
At entry into the study and eight weeks after completion of the intervention
Method of measurement
Medanlou Treatment Adherence Questionnaire

2

Description
Self‑efficacy
Timepoint
At entry into the study and eight weeks after completion of the intervention
Method of measurement
Cardiac Self‑Efficacy Scale (STECA)

3

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
Evaluating the effect of nurse‑led self‑care modules on the clinical outcomes of patients undergoing open‑heart surgery.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Amirhosein Madadi
Street address
Emam Hosein Hospital - Shahid Madani St - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
02173431000-1
Phone
+98 21 7343 1000
Fax
+98 21 7343 1000
Email
info@sbmu.ac.ir
Web page address
https://ehmc.sbmu.ac.ir/

2

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Amirhosein Madadi
Street address
Iran - Tehran - Yadegar emam highway – saadat abad intersection - shahid modarres hospital
City
Tehran
Province
Tehran
Postal code
021-23515
Phone
+98 21 23515
Fax
+98 21 23515
Email
IPD.modares@sbmu.ac.ir
Web page address
https://modarres.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Neda sanaie
Street address
Tehran, Velenjak, Daneshjou Boulevard, Arabi Street, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 23871
Fax
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Neda Sanaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
**Tehran, Valiasr Street, intersection with Ayatollah Hashemi Rafsanjani Highway, opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery.**
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
02188655366-70
Fax
+98 21 8865 5363
Email
nedasanaie@ymail.com
Web page address
https://nm.sbmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Neda Sanaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr Street, intersection with Ayatollah Hashemi Rafsanjani Highway, opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
88655366-337
Fax
+98 21 8865 5363
Email
nedasanaie@ymail.com
Web page address
https://nm.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Neda Sanaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr Street, intersection with Ayatollah Hashemi Rafsanjani Highway, opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
88655366-337
Fax
+98 21 8865 5363
Email
nedasanaie@ymail.com
Web page address
https://nm.sbmu.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all datails
When the data will become available and for how long
2027
To whom data/document is available
everyone
Under which criteria data/document could be used
any condition
From where data/document is obtainable
author
What processes are involved for a request to access data/document
nothing
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