Patient EngagementNCT06643182
Use of Back Support After Transfemoral Angiography
A study testing Back Support in people with Patient Engagement and Femoral Angiography, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patient Engagement, Femoral Angiography
- What is being tested?
- Back Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Sep 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over the age of 18 who underwent femoral coronary angiography,
- Patients who did not have verbal communication problems,
- Patients who consented to participate in the study were determined as patients.
Who cannot join
- Patients who underwent radial angiography,
- Have chronic low back pain,
- Have had previous back surgery/herniated disc,
- Have coagulation problems (PLT<50000 mm3),
- Did not consent to participate in the study,
- Have communication problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tunceli State Hospital
Tunceli
Mehdi Onaç, specialist doctor
About this study
Official title: Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.
Read the detailed description
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.
This study will be conducted to evaluate the effect of back support on patients undergoing transfemoral angiography on the patients' vital signs, which are defined as pulse, blood pressure, respiratory rate and blood oxygen saturation (SPO2), as well as comfort levels indicating satisfaction levels.
The study is planned to be completed between September 1, 2024 and April 1, 2025. The universe of the study, which was conducted as a randomized controlled trial model, consisted of patients who underwent angiography in the cardiovascular surgery intensive care units of Tunceli State Hospital. Randomization of the participants was planned to be assigned to the experimental and control groups via random.org (Back support group=40, Control group=40). "Patient Information Form", "Visual Analog Scale (VAS)" and "Immobilization Comfort Scale (IMC)" will be used in data collection. General linear model and mixed ANOVA analysis will be performed according to the characteristics of the data.
- Conditions
- Patient Engagement, Femoral Angiography
- Being tested
- Back Support
- Keywords
- femoral angiography, back support, vital signs, comfort
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back SupportOther
When the sandbag is to be left by the researcher together with the nurse caring for the patient, the patient will be placed in the left lateral position for a short time, a gel-filled orthopedic non-sweating viscose pillow will be placed in the patient's lumbar region and the patient will be placed in a supine position with the head supported.
| Study group | Role | What they receive |
|---|---|---|
| Back Gupport Group | Experimental | After the transfemoral angiography procedure, the patient will be taken to bed and monitored. Approximately 2 hours after the procedure, under the control of the doctor and nurse, the sheath in the patient's groin area will be pulled and a 3 kg sandbag will be left. A 36x33x10 cm gel-containing visco pillow will be placed in the patient's lumbar cavity by the research nurse and primary nurse to fill the anatomical space. The patient will be monitored in a supine position with the head elevated (30 degrees) and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours. Receives: Other: Back Support |
| Control Group | No intervention | The patients in this group will be monitored in the supine position with the head elevated (30 degrees) without pillow support and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of back support use on pulse
Patients will be monitored for 6 hours in a supported supine position and Pulse will be recorded at 3-hour intervals.
Measured: 6 hour (Data collection time for each patient)
Effect of back support use on blood pressure
Patients will be monitored for 6 hours in a supported supine position and blood pressure will be recorded at 3-hour intervals.m
Measured: 6 hour (Data collection time for each patient)
Effect of back support use on respiratory rate
Patients will be monitored for 6 hours in a supported supine position and respiratory rate will be recorded at 3-hour intervals.m
Measured: 6 hour (Data collection time for each patient)
Effect of back support use on partial oxygen saturation
Patients will be monitored for 6 hours in a supported supine position and partial oxygen saturation will be recorded at 3-hour intervals.m
Measured: 6 hour (Data collection time for each patient)
Effect of back support use on comfort
The immobilization comfort scale consists of 20 items and 6 statements. The total score is between 20 and 120. Scoring was done before and after back support.
Measured: 6 hour
Secondary outcomes (1)
Effect of back support use on pain
The numbers on the pain scale (VAS) are ranked from 0 to 10 at equal intervals, with pain intensity of 1-3 indicating mild pain; 4-6 indicating moderate pain; and 7-10 indicating severe pain. Scoring was done at 0th hour (before back support), 3rd hour (during back support) and 6th hour (after back support).
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643182
- Sponsor's protocol ID
- 2024/5744
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography
- ClinicalTrials.gov ID
- NCT06643182
- Acronym / sponsor ID
- 2024/5744
- Conditions
- Patient Engagement, Femoral Angiography
- Keywords
- femoral angiography, back support, vital signs, comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.
Detailed description
In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.
This study will be conducted to evaluate the effect of back support on patients undergoing transfemoral angiography on the patients' vital signs, which are defined as pulse, blood pressure, respiratory rate and blood oxygen saturation (SPO2), as well as comfort levels indicating satisfaction levels.
The study is planned to be completed between September 1, 2024 and April 1, 2025. The universe of the study, which was conducted as a randomized controlled trial model, consisted of patients who underwent angiography in the cardiovascular surgery intensive care units of Tunceli State Hospital. Randomization of the participants was planned to be assigned to the experimental and control groups via random.org (Back support group=40, Control group=40). "Patient Information Form", "Visual Analog Scale (VAS)" and "Immobilization Comfort Scale (IMC)" will be used in data collection. General linear model and mixed ANOVA analysis will be performed according to the characteristics of the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back Gupport Group | Experimental | Other: Back SupportAfter the transfemoral angiography procedure, the patient will be taken to bed and monitored. Approximately 2 hours after the procedure, under the control of the doctor and nurse, the sheath in the patient's groin area will be pulled and a 3 kg sandbag will be left. A 36x33x10 cm gel-containing visco pillow will be placed in the patient's lumbar cavity by the research nurse and primary nurse to fill the anatomical space. The patient will be monitored in a supine position with the head elevated (30 degrees) and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours. |
| Control Group | No intervention | –The patients in this group will be monitored in the supine position with the head elevated (30 degrees) without pillow support and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over the age of 18 who underwent femoral coronary angiography,
- Patients who did not have verbal communication problems,
- Patients who consented to participate in the study were determined as patients.
Key exclusion criteria (6 listed)
- Patients who underwent radial angiography,
- Have chronic low back pain,
- Have had previous back surgery/herniated disc,
- Have coagulation problems (PLT<50000 mm3),
- Did not consent to participate in 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 |
|---|---|---|
| Back SupportWhen the sandbag is to be left by the researcher together with the nurse caring for the patient, the patient will be placed in the left lateral position for a short time, a gel-filled orthopedic non-sweating viscose pillow will be placed in the patient's lumbar region and the patient will be placed in a supine position with the head supported. | Other | Back Gupport Group |
Primary outcome
Effect of back support use on pulse
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and Pulse will be recorded at 3-hour intervals.
Effect of back support use on blood pressure
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and blood pressure will be recorded at 3-hour intervals.m
Effect of back support use on respiratory rate
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and respiratory rate will be recorded at 3-hour intervals.m
Effect of back support use on partial oxygen saturation
Time frame: 6 hour (Data collection time for each patient)
Patients will be monitored for 6 hours in a supported supine position and partial oxygen saturation will be recorded at 3-hour intervals.m
Effect of back support use on comfort
Time frame: 6 hour
The immobilization comfort scale consists of 20 items and 6 statements. The total score is between 20 and 120. Scoring was done before and after back support.
1 secondary outcome
Effect of back support use on pain
Time frame: 6 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back Support in people with Patient Engagement and Femoral Angiography, run by Inonu 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 3 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Olmaz, PhD (+90 5349598752, dilekolmaz62@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of back support use on pulse (time frame: 6 hour (Data collection time for each patient)). The study lists 5 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 16 Oct 2024.