Cardiac CatheterizationNCT05539092
The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients
A study testing changing angle of bed in people with Cardiac Catheterization, run by Mansoura University.
Trial summary
Care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. In 2019, approximately 18.6 million deaths were attributed to CVD globally. As a consequence, cardiac catheterization remains the criterion standard for evaluation of CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Catheterization
- What is being tested?
- changing angle of bed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 28 Feb 2023
- 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
- Adult patient ≥ 18 years old of both sexes.
- Conscious patients admitted to the CCU after diagnostic or therapeutic cardiac catheterization.
- Patients who will have femoral artery catheterization.
- Patients who will have normal prothrombin time and partial thromboplastin time.
Who cannot join
- Patients who have previous surgery in the iliac or femoral artery.
- Patients who have chronic back pain.
- Patients who have an active bleed¬ing, hematoma and ecchymosis from insertion site prior to the sheath withdrawal.
- Patient who take anti-coagulant drugs and analgesic therapy within the previous 24 hours before the procedure.
About this study
Official title: Faculty of Nursing- Critical Care and Emergency Nursing Department
Care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. In 2019, approximately 18.6 million deaths were attributed to CVD globally. As a consequence, cardiac catheterization remains the criterion standard for evaluation of CAD.
Read the detailed description
This study will be conducted in three phases; preparation, implementation, and evaluation.
- Preparation phase
- Ethical approval will be obtained from the Research Ethics Committee (REC) of the Faculty of Nursing - Mansoura University.
- Content validity of the developed tool will be reviewed by a jury of five experts in the study field and the suggestions of the jury members will be considered.
- The reliability of this tool will be assessed also by using Cronbach's Alpha Test.
- Implementation phase
- An initial assessment will be carried out for all patients to confirm that they are free from the exclusion criteria.
- Patients will be assigned into two groups: intervention group and control group, 41 patients for each group.
- Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission using part I and part II of tool I.
- In both groups after cardiac catheterization procedure: the sheath will be removed immediately by the nurse.
- In the control group: positioning the patients in supine for 6 hours and the affected leg was straight and immobilized.
- In the intervention group: the researcher will change angle of bed from 15° to 45°.
- The severity of pain will be assessed by using part III of tool I for five times starting immediately after sheath removal.
- Vascular complications monitoring scales will be assessed by using tool III for five times starting immediately after sheath removal.
- Evaluation phase This phase aims to investigate the effect of changing angle of bed on pain severity and vascular complications for both groups.
- Conditions
- Cardiac Catheterization
- Being tested
- changing angle of bed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changing angle of bedOther
Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission. the researcher will change angle of bed from 15° to 45°.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | the researcher will change angle of bed from 15° to 45°. The severity of pain will be assessed for five times starting immediately after sheath removal. Vascular complications monitoring scales will be assessed I for five times starting immediately after sheath removal. Receives: Other: changing angle of bed |
| control group | No intervention | positioning the patients in supine for 6 hours and the affected leg was straight and immobilized. The severity of pain will be assessed for five times starting immediately after sheath removal. Vascular complications monitoring scales will be assessed I for five times starting immediately after sheath removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing pain severity according to the numerical pain scale
Patients who receive changing angle of bed after cardiac catheterization will have less pain severity according to the numerical pain scale than those who will receive hospital routine care.
Measured: 6 hours
Secondary outcomes (1)
reduction of vascular complications according to the vascular complications monitoring scales
The vascular complications will be decreased after changing angle of bed among cardiac catheterization patients according to the vascular complications monitoring scales
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara sobh mohamed ramadan ellawindy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539092
- Sponsor's protocol ID
- Ref.no.p 0.0237
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faculty of Nursing- Critical Care and Emergency Nursing Department
- ClinicalTrials.gov ID
- NCT05539092
- Acronym / sponsor ID
- Ref.no.p 0.0237
- Conditions
- Cardiac Catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 14 Sep 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.
Care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. In 2019, approximately 18.6 million deaths were attributed to CVD globally. As a consequence, cardiac catheterization remains the criterion standard for evaluation of CAD.
Detailed description
This study will be conducted in three phases; preparation, implementation, and evaluation.
- Preparation phase
- Ethical approval will be obtained from the Research Ethics Committee (REC) of the Faculty of Nursing - Mansoura University.
- Content validity of the developed tool will be reviewed by a jury of five experts in the study field and the suggestions of the jury members will be considered.
- The reliability of this tool will be assessed also by using Cronbach's Alpha Test.
- Implementation phase
- An initial assessment will be carried out for all patients to confirm that they are free from the exclusion criteria.
- Patients will be assigned into two groups: intervention group and control group, 41 patients for each group.
- Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission using part I and part II of tool I.
- In both groups after cardiac catheterization procedure: the sheath will be removed immediately by the nurse.
- In the control group: positioning the patients in supine for 6 hours and the affected leg was straight and immobilized.
- In the intervention group: the researcher will change angle of bed from 15° to 45°.
- The severity of pain will be assessed by using part III of tool I for five times starting immediately after sheath removal.
- Vascular complications monitoring scales will be assessed by using tool III for five times starting immediately after sheath removal.
- Evaluation phase This phase aims to investigate the effect of changing angle of bed on pain severity and vascular complications for both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: changing angle of bedthe researcher will change angle of bed from 15° to 45°. The severity of pain will be assessed for five times starting immediately after sheath removal. Vascular complications monitoring scales will be assessed I for five times starting immediately after sheath removal. |
| control group | No intervention | –positioning the patients in supine for 6 hours and the affected leg was straight and immobilized. The severity of pain will be assessed for five times starting immediately after sheath removal. Vascular complications monitoring scales will be assessed I for five times starting immediately after sheath removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient ≥ 18 years old of both sexes.
- Conscious patients admitted to the CCU after diagnostic or therapeutic cardiac catheterization.
- Patients who will have femoral artery catheterization.
- Patients who will have normal prothrombin time and partial thromboplastin time.
Key exclusion criteria (4 listed)
- Patients who have previous surgery in the iliac or femoral artery.
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 |
|---|---|---|
| changing angle of bedBefore the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission. the researcher will change angle of bed from 15° to 45°. | Other | intervention group |
Primary outcome
changing pain severity according to the numerical pain scale
Time frame: 6 hours
Patients who receive changing angle of bed after cardiac catheterization will have less pain severity according to the numerical pain scale than those who will receive hospital routine care.
1 secondary outcome
reduction of vascular complications according to the vascular complications monitoring scales
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing changing angle of bed in people with Cardiac Catheterization, run by Mansoura University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
changing pain severity according to the numerical pain scale (time frame: 6 hours). 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 14 Sep 2022.