Open Heart SurgeryNCT05316207
Tele-Nursing Follow-Up After Open Heart Surgery
A study testing Telenursing in people with Open Heart Surgery and Tele-nursing, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Failure to follow-up patients by healthcare professionals after discharge may increase the development of anxiety and complications in patients. Aim: The aim of this study is to determine the effects of tele-nursing method to patients who have undergone Open Heart Surgery (OHS) after discharge on anxiety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Heart Surgery, Tele-nursing
- What is being tested?
- Telenursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 21 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen years and older,
- Able to speak and understand Turkish,
- Without hearing, comprehension, vision and speech problems,
- Open heart surgery for the first time,
- Those who were not diagnosed with depression or anxiety disorder before surgery and didn't use medication for this purpose,
- Having a mobile phone that can take photos by herself/himself or her/his attendants,
- No serious complications to delay hospital discharge,
- Patients who volunteered to participate were included in the study.
Who cannot join
- Patients who wished to withdraw from the study after volunteering were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medical Park Hospital
Gaziantep, Şahinbey, 27027
About this study
Official title: Investigation of the Effect of Tele-Nursing on Anxiety And Complications in Patients With Open Heart Surgery
Introduction: Failure to follow-up patients by healthcare professionals after discharge may increase the development of anxiety and complications in patients.
Aim: The aim of this study is to determine the effects of tele-nursing method to patients who have undergone Open Heart Surgery (OHS) after discharge on anxiety and some other complications.
Material and Methods:This quasi-experimental randomized controlled study, which was conducted in a private hospital between November 2020 and April 2021, included 75 patients, 38 from the Intervention (IG) and 37 from the Control Group (KG). IG and CG patients were provided routine treatment and care. In addition to the IG, training and counselling were provided at least four times by phone calls between the first week after discharge and the end of the first month. Descriptive Form and State-Trait Anxiety Inventory (STAI-S and T) were administered to all patients before discharge, and STAI-S was administered at the end of the first month after discharge. Post-discharge complications were evaluated by medical doctor in both groups. These data, number of hospitalization and readmission rates were obtained from hospital records.
- Conditions
- Open Heart Surgery, Tele-nursing
- Being tested
- Telenursing
- Keywords
- Anxiety, Complication, Readmission, Hospitalization
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelenursingOther
From the end of the first week after discharge to the end of the first month, patients were counseled over the phone during the home process. Complications were followed up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | IG was formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and whose routine controls were determined by the randomization method. The patients in the IG would call by the researcher at least four times, at the end of the first, second, third and fourth weeks after discharge, to provide education and counseling via tele-nursing. In these phone calls, the current problems of the patient, if any, and the issues that should be paid attention to during the home care process after open heart surgery were explained.It was stated that, unlike the patients in CG, patients in IG would be called by the researcher at least four times at the end of the first, second, third and fourth weeks after discharge to provide education and counseling via tele-nursing. Receives: Other: Telenursing |
| Control Group | No intervention | The patients in the CG were formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and who were determined by the randomization method, whose routine controls were made after discharge. No application was made to the patients in the CG by the researcher within the scope of the study. However, the researcher gave the phone number to the patients in the CG in terms of their right to receive ethical and professional care, and it was stated that they could call between 10:00 and 22:00 if needed. The reasons for calling the investigator from the CG were recorded . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of change in anxiety levels between groups before discharge and one month after discharge
Anxiety levels of all participants who met the inclusion criteria were measured using the state and trait anxiety scale in the pre-test. At the end of the first week after discharge, the intervention was started for the patients in the study group and the intervention was completed at the end of the first month after discharge. One month after discharge, the state anxiety levels were measured again with the state anxiety scale.
Measured: State and trait anxiety levels were measured 72 hours before discharge for all participants who met the inclusion criteria.State anxiety levels of all participants were measured one month after discharge.
Secondary outcomes (1)
Rates of Complication Development
The rate of total hospitalization before and after the intervention, the rate of admission to the hospital for examination, leg incision infection, effusion, chest incision infection and other complications that may occur within one month after discharge, according to the groups
Measured: Complications developed in both groups were recorded at the end of the first week and the end of the fourth week after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Nov 2020
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadiriye Pehlivan, Hasan Kalyoncu University
- Investigators
- Kadiriye Pehlivan, MSc RN, Principal investigator, Hasan Kalyoncu UniversityAyla Yava, Prof, RN, Study director, Hasan Kalyoncu Üni̇versi̇tesi̇ University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316207
- Sponsor's protocol ID
- TelenursingOHS
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Tele-Nursing on Anxiety And Complications in Patients With Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05316207
- Acronym / sponsor ID
- TelenursingOHS
- Conditions
- Open Heart Surgery, Tele-nursing
- Keywords
- Anxiety, Complication, Readmission, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 7 Apr 2022 (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.
Introduction: Failure to follow-up patients by healthcare professionals after discharge may increase the development of anxiety and complications in patients.
Aim: The aim of this study is to determine the effects of tele-nursing method to patients who have undergone Open Heart Surgery (OHS) after discharge on anxiety and some other complications.
Material and Methods:This quasi-experimental randomized controlled study, which was conducted in a private hospital between November 2020 and April 2021, included 75 patients, 38 from the Intervention (IG) and 37 from the Control Group (KG). IG and CG patients were provided routine treatment and care. In addition to the IG, training and counselling were provided at least four times by phone calls between the first week after discharge and the end of the first month. Descriptive Form and State-Trait Anxiety Inventory (STAI-S and T) were administered to all patients before discharge, and STAI-S was administered at the end of the first month after discharge. Post-discharge complications were evaluated by medical doctor in both groups. These data, number of hospitalization and readmission rates were obtained from hospital records.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: TelenursingIG was formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and whose routine controls were determined by the randomization method. The patients in the IG would call by the researcher at least four times, at the end of the first, second, third and fourth weeks after discharge, to provide education and counseling via tele-nursing. In these phone calls, the current problems of the patient, if any, and the issues that should be paid attention to during the home care process after open heart surgery were explained.It was stated that, unlike the patients in CG, patients in IG would be called by the researcher at least four times at the end of the first, second, third and fourth weeks after discharge to provide education and counseling via tele-nursing. |
| Control Group | No intervention | –The patients in the CG were formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and who were determined by the randomization method, whose routine controls were made after discharge. No application was made to the patients in the CG by the researcher within the scope of the study. However, the researcher gave the phone number to the patients in the CG in terms of their right to receive ethical and professional care, and it was stated that they could call between 10:00 and 22:00 if needed. The reasons for calling the investigator from the CG were recorded . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eighteen years and older,
- Able to speak and understand Turkish,
- Without hearing, comprehension, vision and speech problems,
- Open heart surgery for the first time,
- Those who were not diagnosed with depression or anxiety disorder before surgery and didn't use medication for this purpose,
Key exclusion criteria (1 listed)
- Patients who wished to withdraw from the study after volunteering were excluded from the study.
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 |
|---|---|---|
| TelenursingFrom the end of the first week after discharge to the end of the first month, patients were counseled over the phone during the home process. Complications were followed up. | Other | Intervention Group |
Primary outcome
Determination of change in anxiety levels between groups before discharge and one month after discharge
Time frame: State and trait anxiety levels were measured 72 hours before discharge for all participants who met the inclusion criteria.State anxiety levels of all participants were measured one month after discharge.
Anxiety levels of all participants who met the inclusion criteria were measured using the state and trait anxiety scale in the pre-test. At the end of the first week after discharge, the intervention was started for the patients in the study group and the intervention was completed at the end of the first month after discharge. One month after discharge, the state anxiety levels were measured again with the state anxiety scale.
1 secondary outcome
Rates of Complication Development
Time frame: Complications developed in both groups were recorded at the end of the first week and the end of the fourth week after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Kadiriye Pehlivan, MSc RN principal investigator
Hasan Kalyoncu University
Ayla Yava, Prof, RN study director
Hasan Kalyoncu Üni̇versi̇tesi̇ University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing in people with Open Heart Surgery and Tele-nursing, run by Hasan Kalyoncu 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 7 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of change in anxiety levels between groups before discharge and one month after discharge (time frame: State and trait anxiety levels were measured 72 hours before discharge for all participants who met the inclusion criteria.State anxiety levels of all participants were measured one month after discharge.). 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 7 Apr 2022.