Protocol summary

Study aim
Determining the Effect of Nursing Care Based on Gordon's Functional Health Pattern on Length of Hospital Stay and Quality of Life in Patients with Acute Coronary Syndrome
Design
This is a randomized, single-blind, parallel-group, controlled clinical trial with intervention and control groups, involving 60 patients, using SPSS software for data analysis.
Settings and conduct
Patients with Acute Coronary Syndrome admitted to the ICUs of hospitals affiliated with Jundishapur University, who are blinded to their group allocation (intervention or control).
Participants/Inclusion and exclusion criteria
(1) confirmed diagnosis of Acute Coronary Syndrome by a cardiologist based on the triple diagnostic triad; (2) age ≥ 18 years; (3) ability to read and write in Persian; (4) full consciousness and orientation to time and place; and (5) no history of cognitive or psychiatric disorders.
Intervention groups
The research group will include ACS patients admitted to the CCU/ICU departments of teaching hospitals affiliated with Ahvaz University of Medical Sciences, who meet the inclusion criteria.
Main outcome variables
Primary Outcomes: 1. Quality of life: Measured using the [e.g., SF-36 or WHOQOL-BREF] questionnaire at three time points: before the intervention, immediately after the intervention, and 1 month after discharge. 2. Length of hospital stay: Number of days from admission to discharge. Clinical Implications of Results: If this care model proves effective, Gordon's Functional Health Pattern model can be adopted as a standard, cost-effective, and practical approach in cardiac wards to improve quality of life and reduce hospital stay duration in patients with acute coronary syndrome. Furthermore, it can be integrated into nursing education curricula.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260612069760N1
Registration date: 2026-07-28, 1405/05/06
Registration timing: registered_while_recruiting

Last update: 2026-07-28, 1405/05/06
Update count: 0
Registration date
2026-07-28, 1405/05/06
Registrant information
Name
Aida Karaminia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2653
Email address
aydakaraminia@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing care based on Gordon's functional health model on length of hospitalization and quality of life in patients with Acute Coronary Syndrome
Public title
The Effect of Targeted Nursing Care on Recovery of Cardiac Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of Acute Coronary Syndrome by a cardiologist based on the triple triad criteria. Patients aged 18 years and older Ability to read and write in Persian Fully conscious and oriented to time and place No history of cognitive or psychiatric disorders
Exclusion criteria:
Patient's unwillingness to continue participation in the study for any reason Deterioration of the participant's condition or death Occurrence of any disease or injury that may affect the participant's functional independence during the study, such as CVA or spinal cord injuries.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants to intervention and control groups will be performed using block randomization. For this purpose, blocks of a specified size (e.g., 4 or 6) will be formed to ensure a balanced number of participants in both groups throughout the study. For each block, a random sequence of letters (A for the intervention group and B for the control group) will be generated using specialized software. These sequences will then be applied consecutively to allocate participants. To ensure allocation concealment and to prevent selection bias, the generated sequences will be written on cards and placed in opaque, sealed, and sequentially numbered envelopes. These envelopes will be kept by an individual who is independent of the enrollment and intervention processes. They will be opened in sequential order only after final confirmation of participant eligibility and completion of baseline assessments, at which point the participant's group assignment will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Block 3, Golestan Female Student Dormitory, Golestan Boulevard
City
Ahvaz
Postal code
6135815751
Approval date
2026-06-07, 1405/03/17
Ethics committee reference number
IR.AJUMS.REC.1405.097

Health conditions studied

1

Description of health condition studied
Patients diagnosed with Acute Coronary Syndrome (ACS)
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
Quality of life assessed using the Seattle Questionnaire before intervention, immediately after intervention, and three months post-intervention.
Timepoint
Three months post-intervention
Method of measurement
Demographic Questionnaire, Seattle Angina Questionnaire (SAQ), Gordon's Functional Health Pattern Assessment Questionnaire

2

Description
Length of hospital stay measured from admission to discharge.
Timepoint
At discharge
Method of measurement
Length of stay is a quantitative and objective variable that, unlike quality of life, does not require a questionnaire or psychometric instrument. This variable is extracted directly from the patient's chart or medical records.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with acute coronary syndrome will receive routine hospital care plus a Gordon's Functional Health Patterns-based nursing care program. The intervention consists of a comprehensive 14-day structured nursing program based on the 11 functional health patterns, including patient education, counseling, nutritional management, physical activity guidance, medication adherence, stress management, and follow-up. Participants will also receive a follow-up telephone call three months after the intervention.
Category
Lifestyle

2

Description
Control group: Control group: Patients with acute coronary syndrome will receive routine hospital care only. They will not receive the Gordon's Functional Health Patterns-based nursing care program. Outcomes will be assessed at the same time points as the intervention group: before the intervention, immediately after the intervention, and three months after the intervention.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
"Teaching hospitals affiliated with Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Neda Sayady
Street address
"Block 3, Golestan Female Student Dormitory, Golestan Boulevard
City
Ahvaz
Postal code
61358157751
Phone
Email
aydakaraminia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Abdullah Rafiei
Street address
"Block 3, Golestan Female Student Dormitory, Golestan Boulevard"
City
Ahvaz
Postal code
613581571
Phone
Email
aydakaraminia@gmail.com
Grant name
Dr. Abdullah Rafiei
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
20
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
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Sayady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
"Block 3, Golestan Female Student Dormitory, Golestan Boulevard"
City
Ahvaz
Province
Khuzestan
Postal code
6135815751
Phone
986133112653
Email
aydakaraminia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Sayady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
"Golestan Expressway, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khuzestan
Postal code
6135715794
Phone
986133110000
Email
aydakaraminia@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Sayady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
"Block 3, Golestan Female Student Dormitory, Golestan Boulevard
City
Ahvaz
Province
Khuzestan
Postal code
6135815751
Phone
989031354359
Email
sayadi_neda@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only limited portions of the information pertaining to the original message or equivalent content may be disclosed.
When the data will become available and for how long
The access period will commence following the publication of the study results.
To whom data/document is available
For all people
Under which criteria data/document could be used
Utilization of Gordon's Functional Health Pattern Model for the Enhancement of Patients' Quality of Life
From where data/document is obtainable
Reputable Scientific Websites
What processes are involved for a request to access data/document
A systematic search was performed using the following keywords: Gordon, Quality of Life, and Acute Coronary Syndrome.
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