Open Heart SurgeryNCT06801145
The Effect of Video-supported Education on Anxiety Levels and the ICU Experience
A study testing Education with Video in people with Open Heart Surgery, run by Zeynep Turak at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effects of video-assisted education about the intensive care process on intensive care experiences and anxiety levels of patients scheduled for open-heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- Education with Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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
- Patients aged 18 and over,
- Cognitively competent,
- Communicative and cooperative,
- Patients undergoing planned surgery (patients not admitted for emergency surgery),
- Patients without a psychiatric diagnosis,
- Patients with sensory impairments such as vision, hearing, or speech,
- Patients with stable hemodynamic status in the clinic,
- Patients who volunteered to participate in the study were included in the study.
Who cannot join
- Patients who did not volunteer to participate,
- Patients whose surgery was canceled,
- Patients who underwent emergency surgery,
- Patients who underwent combined bypass and valve surgery,
- Patients with previous intensive care experience,
- Patients who developed complications before, during, or after surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Video-supported Education About the Intensive Care Process on Anxiety Levels and the ICU Experience of Patients Scheduled for Open-heart Surgery
This study was conducted to examine the effects of video-assisted education about the intensive care process on intensive care experiences and anxiety levels of patients scheduled for open-heart surgery.
Research Hypotheses H01: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does not affect their experiences of intensive care.
Read more
H1: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does affect their experiences of intensive care.
H02: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does not affect patients' anxiety levels.
H2: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does affect patients' anxiety levels.
Read the detailed description
The study will include an experimental and a control group. Patients in the experimental group will be administered the Patient Introduction Form, Trait Anxiety and State Anxiety Scales 48 hours before surgery. Then, video-assisted training will be given about the intensive care process, and the state anxiety scale will be applied again 24 hours before the surgery. Twenty-four hours after discharge from the intensive care unit to the clinic, the State Anxiety Scale and Intensive Care Experience Scales will be applied again. These scales will also be applied to patients in the control group who did not receive video-assisted education. Control group patients will not receive any intervention other than standard nursing care.
- Conditions
- Open Heart Surgery
- Being tested
- Education with Video
- Keywords
- BYPASS, OPEN HEART SUNGERY, Anxiety, patient education, intensive care experience
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education with VideoOther
Patients in the experimental group will be trained by the researcher 48 hours before the surgery with a video providing information about the intensive care process.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Video training will be provided 48 hours before the surgery. Receives: Other: Education with Video |
| Control group | No intervention | This group will receive no intervention other than the applied scales; only standard nursing care will be maintained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care experience
Intensive care experience will be evaluated with the Intensive Care Experience Scale. The scale has been developed to evaluate the experiences of patients in the intensive care unit.10 of the scale questions evaluate the frequency of the emotional condition in which the patient live, while the other 9 evaluate the compliance of the patient to intensive care. The substances prepared to evaluate the harmony of the patient in intensive care; Scored between 1 and 5.
Measured: 24 hours after arriving from intensive care care
Anxiety level
Anxiety level will be evaluated with the State-Trait Anxiety Inventory.The State-Trait Anxiety Inventory was first developed by Spielberger and colleagues in 1971, and its Turkish adaptation was completed by Öner and Le Compte in 1985. The scale consists of a total of 40 items and two separate subscales. The first 20 items assess individuals' state anxiety levels, while the remaining 20 items assess trait anxiety levels.
Measured: 48 hours before surgery, 24 hours before surgery, 24 hours after intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Oct 2023
- Primary completion30 Jan 2024
- Study completion30 Jun 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Turak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Turak, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801145
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/363
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2024
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-supported Education About the Intensive Care Process on Anxiety Levels and the ICU Experience of Patients Scheduled for Open-heart Surgery
- ClinicalTrials.gov ID
- NCT06801145
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/363
- Conditions
- Open Heart Surgery
- Keywords
- BYPASS, OPEN HEART SUNGERY, Anxiety, patient education, intensive care experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Zeynep TurakUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 30 Jan 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 study was conducted to examine the effects of video-assisted education about the intensive care process on intensive care experiences and anxiety levels of patients scheduled for open-heart surgery.
Research Hypotheses H01: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does not affect their experiences of intensive care.
H1: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does affect their experiences of intensive care.
H02: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does not affect patients' anxiety levels.
H2: Video-assisted education regarding the intensive care process provided to patients undergoing open heart surgery does affect patients' anxiety levels.
Detailed description
The study will include an experimental and a control group. Patients in the experimental group will be administered the Patient Introduction Form, Trait Anxiety and State Anxiety Scales 48 hours before surgery. Then, video-assisted training will be given about the intensive care process, and the state anxiety scale will be applied again 24 hours before the surgery. Twenty-four hours after discharge from the intensive care unit to the clinic, the State Anxiety Scale and Intensive Care Experience Scales will be applied again. These scales will also be applied to patients in the control group who did not receive video-assisted education. Control group patients will not receive any intervention other than standard nursing care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Education with VideoVideo training will be provided 48 hours before the surgery. |
| Control group | No intervention | –This group will receive no intervention other than the applied scales; only standard nursing care will be maintained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 and over,
- Cognitively competent,
- Communicative and cooperative,
- Patients undergoing planned surgery (patients not admitted for emergency surgery),
- Patients without a psychiatric diagnosis,
Key exclusion criteria (6 listed)
- Patients who did not volunteer to participate,
- Patients whose surgery was canceled,
- Patients who underwent emergency surgery,
- Patients who underwent combined bypass and valve surgery,
- Patients with previous intensive care experience,
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 |
|---|---|---|
| Education with VideoPatients in the experimental group will be trained by the researcher 48 hours before the surgery with a video providing information about the intensive care process. | Other | Experimental group |
Primary outcome
Intensive care experience
Time frame: 24 hours after arriving from intensive care care
Intensive care experience will be evaluated with the Intensive Care Experience Scale. The scale has been developed to evaluate the experiences of patients in the intensive care unit.10 of the scale questions evaluate the frequency of the emotional condition in which the patient live, while the other 9 evaluate the compliance of the patient to intensive care. The substances prepared to evaluate the harmony of the patient in intensive care; Scored between 1 and 5.
Anxiety level
Time frame: 48 hours before surgery, 24 hours before surgery, 24 hours after intensive care unit
Anxiety level will be evaluated with the State-Trait Anxiety Inventory.The State-Trait Anxiety Inventory was first developed by Spielberger and colleagues in 1971, and its Turkish adaptation was completed by Öner and Le Compte in 1985. The scale consists of a total of 40 items and two separate subscales. The first 20 items assess individuals' state anxiety levels, while the remaining 20 items assess trait anxiety levels.
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 15 Dec 2025.
- 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.
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 Education with Video in people with Open Heart Surgery, run by Zeynep Turak 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 6 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 15 Dec 2025. 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?
Intensive care experience (time frame: 24 hours after arriving from intensive care care). 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 15 Dec 2025.