Family SizeCABGNCT07243925
Effect of Family Participation-Based Intervention Before Coronary Artery Bypass Grafting (CABG) on Patients' Anxiety, Independence, and Psychological Resilience: A Randomized Controlled Trial
A study testing Family Involvement-Based Nursing Intervention in people with Family Size and Coronary Artery Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was conducted to examine the effect of a family-based intervention prior to coronary artery bypass grafting (CABG) surgery on patients' psychosocial and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Family Size, Coronary Artery Disease
- What is being tested?
- Family Involvement-Based Nursing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Undergoing CABG surgery for the first time
- Being conscious and able to communicate
- Voluntarily agreeing to participate
- Having at least one family member who is able to be involved in the patient care process
Who cannot join
- Having a severe cognitive or psychiatric disorder
- Requiring prolonged intensive care admission due to postoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial was conducted to examine the effect of a family-based intervention prior to coronary artery bypass grafting (CABG) surgery on patients' psychosocial and functional outcomes. In the intervention group, family members who would participate in the care process received structured training, and their active participation in the pre- and post-operative care process was ensured. The control group received standard care.
The study found that the family-based intervention reduced patients' preoperative anxiety levels, supported their independence, and strengthened their psychological resilience. The findings suggest that encouraging family involvement in patient care prior to CABG surgery can significantly contribute to both improving psychosocial adjustment and supporting the recovery process.
Read the detailed description
Coronary Artery Bypass Grafting (CABG) surgery is a life-saving intervention in the treatment of cardiac diseases; however, it poses significant psychosocial and functional challenges for patients. In the preoperative period, uncertainty, fear of death, and concerns regarding recovery increase patients' anxiety levels, while in the postoperative period, loss of independence, limitations in daily living activities, and decreased psychological resilience are frequently observed. Existing literature predominantly focuses on pharmacological approaches or standard care practices for managing these issues, while studies systematically examining family involvement as an intervention model remain limited. This study evaluated the effects of a family involvement-based structured intervention on anxiety, independence, and psychological resilience in patients undergoing CABG surgery, using a randomized controlled design. Within the intervention, first-degree family members who would participate in the patient's care received training covering the surgical process, care needs, and psychosocial support strategies, and were actively engaged in both pre- and postoperative patient care. The results demonstrated that the family involvement-based intervention significantly reduced patients' anxiety, enhanced independence, and improved psychological resilience. These findings highlight that family involvement contributes not only to the physical care of CABG patients but also to their psychosocial adaptation and recovery processes. As one of the first studies to address these dimensions simultaneously, this research provides an original contribution to strengthening family-centered care in nursing practice and restructuring surgical patient care protocols.
- Conditions
- Family Size, Coronary Artery Disease
- Being tested
- Family Involvement-Based Nursing Intervention
- Keywords
- family, coronary, family involvement
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Involvement-Based Nursing InterventionOther
Also called Family Group
The intervention process began with the identification of a family member who could actively participate in the patient's care. These individuals were typically defined as spouses, children, siblings, or close relatives living together. Patients included in the study were admitted to the cardiovascular surgery ward approximately three days before the planned surgery. During this period, routine preoperative preparations were carried out for the patients. These preparations included carotid and saphenous vein Doppler ultrasonography, consultations with the pulmonary medicine and cardiology departments, and preoperative blood preparation
| Study group | Role | What they receive |
|---|---|---|
| Family Involvement Intervention Group | Experimental | Family Involvement Intervention Group Receives: Other: Family Involvement-Based Nursing Intervention |
| Standard Care Control Group | No intervention | Standard Care Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Level
Patients' anxiety levels prior to coronary artery bypass graft (CABG) surgery will be assessed using the State Anxiety Scale (SAS). The scale consists of 20 items and yields scores ranging from 20 to 80; higher scores indicate higher anxiety levels. The measurement will be conducted in person 24 hours before the surgical procedure.
Measured: Measured on the day before surgery
Psychological Resilience Assessed by the Brief Resilience Scale (BRS)
Participants' psychological resilience levels will be assessed using the Brief Resilience Scale (BRS). The scale consists of 6 items and is scored on a 1-5 point scale. The average score is calculated; higher scores indicate stronger psychological resilience. The measurement will be taken prior to the surgical procedure (24 hours beforehand).
Measured: The day before the surgery
Secondary outcomes (1)
Functional Independence in Activities of Daily Living Assessed by the Modified Barthel Index (MBI)
Participants' levels of independence in daily living activities will be assessed using the Modified Barthel Index (MBI). The MBI measures 10 basic activities of daily living (e.g., eating, bathing, dressing, mobility, toileting). The score range is 0-100; a higher score indicates greater independence. The measurement is taken upon discharge from the hospital (approximately 5-7 days after surgery).
Measured: The measurement is taken upon discharge from the hospital (approximately 5-7 days after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Oct 2025
- Primary completion30 Jun 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family SizeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Sir, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243925
- Sponsor's protocol ID
- CABG-FAMINT-TR-2025
- Acronym
- CABG
- Status last verified
- Jul 2026
- First submitted
- 22 Sep 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Family Participation-Based Intervention Before Coronary Artery Bypass Grafting (CABG) on Patients' Anxiety, Independence, and Psychological Resilience: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07243925
- Acronym / sponsor ID
- CABG / CABG-FAMINT-TR-2025
- Conditions
- Family Size, Coronary Artery Disease
- Keywords
- family, coronary, family involvement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial was conducted to examine the effect of a family-based intervention prior to coronary artery bypass grafting (CABG) surgery on patients' psychosocial and functional outcomes. In the intervention group, family members who would participate in the care process received structured training, and their active participation in the pre- and post-operative care process was ensured. The control group received standard care.
The study found that the family-based intervention reduced patients' preoperative anxiety levels, supported their independence, and strengthened their psychological resilience. The findings suggest that encouraging family involvement in patient care prior to CABG surgery can significantly contribute to both improving psychosocial adjustment and supporting the recovery process.
Detailed description
Coronary Artery Bypass Grafting (CABG) surgery is a life-saving intervention in the treatment of cardiac diseases; however, it poses significant psychosocial and functional challenges for patients. In the preoperative period, uncertainty, fear of death, and concerns regarding recovery increase patients' anxiety levels, while in the postoperative period, loss of independence, limitations in daily living activities, and decreased psychological resilience are frequently observed. Existing literature predominantly focuses on pharmacological approaches or standard care practices for managing these issues, while studies systematically examining family involvement as an intervention model remain limited. This study evaluated the effects of a family involvement-based structured intervention on anxiety, independence, and psychological resilience in patients undergoing CABG surgery, using a randomized controlled design. Within the intervention, first-degree family members who would participate in the patient's care received training covering the surgical process, care needs, and psychosocial support strategies, and were actively engaged in both pre- and postoperative patient care. The results demonstrated that the family involvement-based intervention significantly reduced patients' anxiety, enhanced independence, and improved psychological resilience. These findings highlight that family involvement contributes not only to the physical care of CABG patients but also to their psychosocial adaptation and recovery processes. As one of the first studies to address these dimensions simultaneously, this research provides an original contribution to strengthening family-centered care in nursing practice and restructuring surgical patient care protocols.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Involvement Intervention Group | Experimental | Other: Family Involvement-Based Nursing InterventionFamily Involvement Intervention Group |
| Standard Care Control Group | No intervention | –Standard Care Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 18 years of age or older
- Undergoing CABG surgery for the first time
- Being conscious and able to communicate
- Voluntarily agreeing to participate
- Having at least one family member who is able to be involved in the patient care process
Key exclusion criteria (2 listed)
- Having a severe cognitive or psychiatric disorder
- Requiring prolonged intensive care admission due to postoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Involvement-Based Nursing InterventionAlso: Family GroupThe intervention process began with the identification of a family member who could actively participate in the patient's care. These individuals were typically defined as spouses, children, siblings, or close relatives living together. Patients included in the study were admitted to the cardiovascular surgery ward approximately three days before the planned surgery. During this period, routine preoperative preparations were carried out for the patients. These preparations included carotid and saphenous vein Doppler ultrasonography, consultations with the pulmonary medicine and cardiology departments, and preoperative blood preparation | Other | Family Involvement Intervention Group |
Primary outcome
Preoperative Anxiety Level
Time frame: Measured on the day before surgery
Patients' anxiety levels prior to coronary artery bypass graft (CABG) surgery will be assessed using the State Anxiety Scale (SAS). The scale consists of 20 items and yields scores ranging from 20 to 80; higher scores indicate higher anxiety levels. The measurement will be conducted in person 24 hours before the surgical procedure.
Psychological Resilience Assessed by the Brief Resilience Scale (BRS)
Time frame: The day before the surgery
Participants' psychological resilience levels will be assessed using the Brief Resilience Scale (BRS). The scale consists of 6 items and is scored on a 1-5 point scale. The average score is calculated; higher scores indicate stronger psychological resilience. The measurement will be taken prior to the surgical procedure (24 hours beforehand).
1 secondary outcome
Functional Independence in Activities of Daily Living Assessed by the Modified Barthel Index (MBI)
Time frame: The measurement is taken upon discharge from the hospital (approximately 5-7 days after surgery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. No, IPD will not be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Involvement-Based Nursing Intervention in people with Family Size and Coronary Artery Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Level (time frame: Measured on the day before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.