- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664306
Tele-Nursing Counseling in Coronary Artery Bypass Graft Surgery
The Effect of Tele-Nursing Counseling on Symptom Control and Self Care Strength in Patients Undergoing Coronary Artery Bypass Graft Surgery
It was planned as randomized controlled experimental study to examine the effect of post discharge telenursing counseling on symptom control and self-care in patients who undergoing coronary artery bypass graft surgery.
The research was carried out between July 2022 and July 2023, Istanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Cardiovascular Surgery (CVS) Clinic. The sample of the study consisted of patients, 36 intervention and 36 control. In the study, ethics committee approval, institutional permissions and written consent were obtained from the patients. Data were collected with the Personel Information Form, Cardiac Surgery Symptom Inventory and Self-Care Strength scale.Cardiac Surgery Symptom Inventory and Self-Care Scale were administered to the control group in the first 24 hours of discharge and in the 3rd week after discharge. The Cardiac Surgery Symptom Inventory and Self-Care Scale were evaluated in the intervention group by applying a telephone call protocol in the first 24 hours, first week, second week and third week of discharge.Data were evaluated with Kolmogorov-Smirnov test, ANAOVA (variance) test, Tukey test, Chi-Square tests, Pearson correlation test and Cronbach alpha reliability coefficients using SPPS software version 26 (IBM Corp, Armonk, NY,USA). All analyzes were performed with a 95% confidence interval.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kartal
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Istanbul, Kartal, Turkey (Türkiye), 34870
- Fenerbahce University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being the first patient to undergo open heart surgery,
- Not having undergone any other surgical procedures during heart surgery,
- Being able to read and write Turkish,
- Being able to communicate by telephone,
- Volunteering to participate in the research.
Exclusion Criteria:
- Having hearing, comprehension, vision, and speech problems;
- Having neurological diseases such as dementia or Alzheimer's;
- Developing complications after discharge and deciding on a second surgical intervention;
- Not having a phone and not being able to communicate regularly.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experimental group
The experimental group was contacted by phone once a week, starting on the day they were discharged and continuing for three weeks thereafter.
The meetings were limited to 10 minutes.
Data was collected from patients at each interview using the "Self-Care Ability Scale" and the "Cardiac Surgery Symptom Inventory".
Calls were made and data recorded in accordance with the Telephone Calling Protocol.
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Complications following coronary artery bypass graft surgery typically occur within the first six weeks.
Patients who do not develop complications postoperative period are discharged within an average of 7 days and spend a large part of their recovery at home.
Early diagnosis and prevention of complications that may arise after hospital discharge are possible with good monitoring and care.Telephone Counseling Form: The protocol was developed considering the times when patients undergoing open heart surgery experience the most problems and need support after discharge.Telephone Interview Protocol: This system was developed to support interpersonal interaction, problem-solving, and socio-emotional communication, and conceptually divides communication into two main categories.Self-Care Ability Scale:This scale,designed to determine individuals' ability and capacity to care for themselves.Cardiac Surgery Symptom Inventory (CSSI): The original inventory consists of 5 sub-dimensions.
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No Intervention: Control group
The control group was contacted by phone a total of two times.
The meetings were limited to 10 minutes.
Telephone conversations were conducted in accordance with the Telephone Dialing Protocol.
Patients were contacted by phone on the day of their discharge and again in the third week after discharge.Data was collected in each interview using the "Self-Care Power Scale" and the "Cardiac Surgery Symptom Inventory".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patients in the experimental group who received post-discharge telenursing counseling after coronary artery bypass graft surgery reported fewer symptoms compared to the control group.
Time Frame: Three weeks
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The symptoms experienced by the experimental group were recorded according to the Cardiac Surgery Symptom Inventory through telephone interviews conducted over a period of 4 weeks.
Cardiac Surgery Symptom Inventory (CSSI): The original inventory contains 76 items and consists of 5 sub-dimensions: general, cardiac, trunk, lower and upper extremity symptoms.
The scale is unidimensional and consists of 35 items.
The inventory is Likert-type, and symptoms are rated on a scale of 0-4 as "None", "Very Little", "Moderate", "Much", "Quite a lot".
Following the counseling sessions, inventory scores were calculated based on patient statements and compared with a control group.
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Three weeks
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Patients in the experimental group who received telenursing counseling after discharge from coronary artery bypass graft surgery had higher self-care abilities compared to the control group.
Time Frame: Three weeks
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After receiving telephone-based counseling training, patients in the study group were assessed weekly for their self-care abilities for four weeks.
Self-Care Ability Scale was used to assign scores based on patients' statements.
Self-Care Ability Scale: This scale, designed to determine individuals' ability and capacity to care for themselves, consists of 35 items.
The scale focuses on individuals' self-assessment of their engagement in self-care activities.
Each item is scored from 0 to 4. Individuals' orientation towards self-care is determined by participants' responses on a 5-point Likert-type scale.
The response "Does not describe me at all" receives 0 points, while the others receive 1 point each: "Does not describe me much," 2 points each: "No opinion," 3 points each: "Describes me somewhat," and 4 points each: "Describes me very much."
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Three weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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