Coronary AngiographyNCT06844682
Effect of Position on Back Pain and Comfort After Angiography
A study testing intervention group in people with Coronary Angiography, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
After coronary angiography, back pain and comfort levels were measured while the intervention group was positioned and the control group was not positioned Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2023to 28 Feb 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary angiography for the first time in the coronary intensive care unit and cardiology clinic
- Volunteer to participate in the study
- Femoral angiography procedure performed
- It created patients who had no obstacle to communication.
Who cannot join
- More than one coronary angiography procedure was performed
- Not volunteering to participate in the study
- Radial angiography procedure was performed
- Having a history of back surgery, existing hernia, or chronic waist or back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Posıtıon Gıven to Patıents After Coronary Angıography on Back Paın and Comfort
After coronary angiography, back pain and comfort levels were measured while the intervention group was positioned and the control group was not positioned
Read the detailed description
Patients were assigned to the control and intervention groups by the minimization method. Data were collected using the Visual Analog Scale (VAS) and a Patient Introduction Form to assess the pain and comfort levels of the patients. Prior to the starting the research, the necessary permissions were obtained from the institution where the study was conducted, from the patients and the ethics committee. In the analysis of data, frequency and percentage values, Kolmogorov-Smirnov test for the normal distribution of continuous variables, chi-square for comparisons of qualitative variables, two-way analysis of variance for comparison of repeated measurements of pain and comfort scores according to groups, and the relationship between two continuous variables were evaluated with the Pearson correlation coefficient. p<0.05 was considered statistically significant. IBM SPSS Statistics 23 package program was used for the analysis of the date. The intervention group was hospitalized in supine position after coronary angiography. The first measurement was taken when the patient was placed in bed after the procedure, and the Patient Introduction Form and VAS for comfort and pain were applied (Hour 0). Following the withdrawal of the mattresses, the patient was given the semi-fowler position. VAS was applied at the 2nd and 4th hours after the positioning. Patients in the control group were placed to bed in the supine position in accordance with the routine practice of the clinic at the exit of coronary angiography and were allowed to stay in this position for six hours. When the patients were put to in bed, the Patient Introduction Form, VAS were applied for comfort and pain (0. hour). VAS was applied at the 2nd and 4th hours following the removal of the mattresses. Patients' back pain and comfort were evaluated, and the results were recorded on the relevant forms.
- Conditions
- Coronary Angiography
- Being tested
- intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupOther
Following the removal of the mattresses, the patient was placed in the semi-fawler position.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | At the end of CAG, the patients were laid in the supine position in line with the routine practice of the clinic and were allowed to remain in this position for 6 hours. While lying in bed, the patient identification form and VAS for comfort and pain were applied (Hour 0). VAS was applied at the 2nd and 4th hours following the removal of the mattresses. The patients' back pain and comfort were evaluated and the results were recorded on the relevant forms. |
| intervention group | Experimental | After CAG, the patients were placed on the bed in the supine position. The first measurement was taken when he was put to bed after CAG, and the patient introduction form and VAS for comfort and pain were applied (0th hour). Following the removal of the mattresses, the patient was placed in the semi-fawler position. VAS was applied 2 and 4 hours after positioning. The patients' back pain and comfort were evaluated with the given position, and the results were recorded on the relevant forms. Receives: Other: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
control group
Patients were put to bed in the supine position at the exit of the CAG in accordance with the routine practice of the clinic and were allowed to stay in this position for 6 hours. When the patient was put to bed, VAS was applied for the patient introduction form, comfort and pain (0. hour). 2 From the withdrawal of mattresses. and 4. during the hours, VAS was applied. The patients' back pain and comfort were evaluated and the results were recorded in the relevant forms.
Measured: three months
intervention group
The patients were put to bed after KAG. The first measurement was taken when he was put to bed after KAG. The patient introduction form, VAS were applied for comfort and pain (0. At sa Tu). Following the withdrawal of the mattresses, the patient was given the semi-fawler position. 2 After being given the position. and 4. hours later, VAS was applied. The back pain and comfort of the patients were evaluated with the given position and the results were recorded on the relevant forms.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start5 Nov 2023
- Primary completion10 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyüp Fırat, Sanko University
- Investigators
- Eyüp FIRAT, Principal investigator, SANKO Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844682
- Sponsor's protocol ID
- AIBU-SBF-EF-01
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 25 Feb 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Posıtıon Gıven to Patıents After Coronary Angıography on Back Paın and Comfort
- ClinicalTrials.gov ID
- NCT06844682
- Acronym / sponsor ID
- AIBU-SBF-EF-01
- Conditions
- Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 25 Feb 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.
After coronary angiography, back pain and comfort levels were measured while the intervention group was positioned and the control group was not positioned
Detailed description
Patients were assigned to the control and intervention groups by the minimization method. Data were collected using the Visual Analog Scale (VAS) and a Patient Introduction Form to assess the pain and comfort levels of the patients. Prior to the starting the research, the necessary permissions were obtained from the institution where the study was conducted, from the patients and the ethics committee. In the analysis of data, frequency and percentage values, Kolmogorov-Smirnov test for the normal distribution of continuous variables, chi-square for comparisons of qualitative variables, two-way analysis of variance for comparison of repeated measurements of pain and comfort scores according to groups, and the relationship between two continuous variables were evaluated with the Pearson correlation coefficient. p<0.05 was considered statistically significant. IBM SPSS Statistics 23 package program was used for the analysis of the date. The intervention group was hospitalized in supine position after coronary angiography. The first measurement was taken when the patient was placed in bed after the procedure, and the Patient Introduction Form and VAS for comfort and pain were applied (Hour 0). Following the withdrawal of the mattresses, the patient was given the semi-fowler position. VAS was applied at the 2nd and 4th hours after the positioning. Patients in the control group were placed to bed in the supine position in accordance with the routine practice of the clinic at the exit of coronary angiography and were allowed to stay in this position for six hours. When the patients were put to in bed, the Patient Introduction Form, VAS were applied for comfort and pain (0. hour). VAS was applied at the 2nd and 4th hours following the removal of the mattresses. Patients' back pain and comfort were evaluated, and the results were recorded on the relevant forms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –At the end of CAG, the patients were laid in the supine position in line with the routine practice of the clinic and were allowed to remain in this position for 6 hours. While lying in bed, the patient identification form and VAS for comfort and pain were applied (Hour 0). VAS was applied at the 2nd and 4th hours following the removal of the mattresses. The patients' back pain and comfort were evaluated and the results were recorded on the relevant forms. |
| intervention group | Experimental | Other: intervention groupAfter CAG, the patients were placed on the bed in the supine position. The first measurement was taken when he was put to bed after CAG, and the patient introduction form and VAS for comfort and pain were applied (0th hour). Following the removal of the mattresses, the patient was placed in the semi-fawler position. VAS was applied 2 and 4 hours after positioning. The patients' back pain and comfort were evaluated with the given position, and the results were recorded on the relevant forms. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Coronary angiography for the first time in the coronary intensive care unit and cardiology clinic
- Volunteer to participate in the study
- Femoral angiography procedure performed
- It created patients who had no obstacle to communication.
Key exclusion criteria (4 listed)
- More than one coronary angiography procedure was performed
- Not volunteering to participate in the study
- Radial angiography procedure was performed
- Having a history of back surgery, existing hernia, or chronic waist or back pain
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 |
|---|---|---|
| intervention groupFollowing the removal of the mattresses, the patient was placed in the semi-fawler position. | Other | intervention group |
Primary outcome
control group
Time frame: three months
Patients were put to bed in the supine position at the exit of the CAG in accordance with the routine practice of the clinic and were allowed to stay in this position for 6 hours. When the patient was put to bed, VAS was applied for the patient introduction form, comfort and pain (0. hour). 2 From the withdrawal of mattresses. and 4. during the hours, VAS was applied. The patients' back pain and comfort were evaluated and the results were recorded in the relevant forms.
intervention group
Time frame: three months
The patients were put to bed after KAG. The first measurement was taken when he was put to bed after KAG. The patient introduction form, VAS were applied for comfort and pain (0. At sa Tu). Following the withdrawal of the mattresses, the patient was given the semi-fawler position. 2 After being given the position. and 4. hours later, VAS was applied. The back pain and comfort of the patients were evaluated with the given position and the results were recorded on the relevant forms.
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 25 Feb 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.
Eyüp FIRAT principal investigator
SANKO Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Coronary Angiography, run by Sanko 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 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: finished, as of the sponsor's last update on 25 Feb 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?
control group (time frame: three months). 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 25 Feb 2025.