Coronary AngiographySB-FCRNCT07889479
Effects of Stress Ball Use During Femoral Catheter Removal After Coronary Angiography
A study testing Stress Ball Intervention in people with Coronary Angiography, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of using a stress ball during femoral catheter removal on quality of recovery, patient comfort, and pain in adults undergoing coronary angiography. The study was conducted at a hospital in Istanbul, Türkiye, between November 2024 and May 2025. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Stress Ball Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 28 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- No communication difficulties that would prevent participation in the study.
- Adequate mental status to participate in the study.
- No physical limitations preventing the use of a stress ball.
- Underwent coronary angiography via femoral arterial access.
- No complications during the coronary angiography procedure.
- Voluntary agreement to participate in the study and provision of written informed consent.
Who cannot join
- Not meeting the inclusion criteria.
- Requesting withdrawal from the study at any stage.
- Being discharged before completion of data collection.
- Developing complications during the intervention or data collection process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Stress Ball Use During Femoral Catheter Removal on Quality of Recovery, Comfort, and Pain Following Coronary Angiography: A Randomized Controlled Trial
This study aimed to evaluate the effects of using a stress ball during femoral catheter removal on quality of recovery, patient comfort, and pain in adults undergoing coronary angiography.
The study was conducted at a hospital in Istanbul, Türkiye, between November 2024 and May 2025. A total of 84 patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups, with 42 patients in each group.
Read more
Patients in the intervention group were asked to repeatedly squeeze and release a stress ball during femoral catheter removal. Patients in the control group received routine clinical care without the stress ball intervention.
Pain was assessed 15 minutes after catheter removal. Quality of recovery and patient comfort were evaluated before discharge using standardized assessment scales.
The study was designed to determine whether stress ball use could improve recovery and comfort and reduce pain during care following coronary angiography.
Read the detailed description
Femoral catheter removal following coronary angiography may cause pain, discomfort, and anxiety, potentially affecting patients' recovery experiences. Simple, non-pharmacological nursing interventions may help improve patient comfort during this procedure.
This study was designed as a single-center, two-arm, parallel-group randomized controlled trial to investigate the effects of stress ball use during femoral catheter removal on quality of recovery, perianesthesia comfort, and pain.
Adult patients undergoing coronary angiography via femoral arterial access were randomly assigned to an intervention group or a control group. In the intervention group, patients were instructed to repeatedly squeeze a medium-firm silicone stress ball while counting to three and then release it during catheter removal. Patients in the control group received routine clinical care without the stress ball intervention.
Pain intensity was assessed using a Numerical Rating Scale 15 minutes after catheter removal. Quality of recovery and perianesthesia comfort were assessed using standardized scales before discharge.
The study evaluated whether this simple, low-cost, non-pharmacological intervention could improve patient-reported recovery and comfort and reduce pain associated with femoral catheter removal.
- Conditions
- Coronary Angiography
- Being tested
- Stress Ball Intervention
- Keywords
- Coronary Angiography, Femoral Catheter Removal, Stress Ball, Quality of Recovery, Patient Comfort, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball InterventionOther
Participants assigned to the intervention group were instructed to use a medium-sized, medium-firm silicone stress ball during femoral catheter removal following coronary angiography. Participants repeatedly squeezed the stress ball while counting to three and then released it. This procedure was continued during catheter removal as a non-pharmacological nursing intervention. All participants also received routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | Participants in the intervention group received routine clinical care and were instructed to use a medium-sized, medium-firm silicone stress ball during femoral catheter removal following coronary angiography. Participants repeatedly squeezed the stress ball while counting to three and then released it, continuing this procedure during catheter removal. Receives: Other: Stress Ball Intervention |
| Control Group | No intervention | Participants in the control group received routine clinical care during femoral catheter removal following coronary angiography. No stress ball intervention was administered. Pain intensity was assessed 15 minutes after catheter removal, while quality of recovery and perianesthesia comfort were evaluated before discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-14 Scale (QoR-14)
Patient comfort was assessed using the 24-item Perianesthesia Comfort Scale (PCS), based on Kolcaba's Comfort Theory. Each item is rated on a 6-point Likert scale, with negatively worded items reverse-scored. Total scores range from 24 to 144, with higher scores indicating greater comfort.
Measured: Once, at 24 hours after coronary angiography, immediately before hospital discharge.
Secondary outcomes (2)
Perianesthesia Comfort Scale (PCS)
Patient comfort was assessed using the 24-item Perianesthesia Comfort Scale (PCS), based on Kolcaba's Comfort Theory. Each item is rated on a 6-point Likert scale, with negatively worded items reverse-scored. Total scores range from 24 to 144, with higher scores indicating greater comfort. The scale was administered before hospital discharge.
Measured: Once, at 24 hours after coronary angiography, immediately before hospital discharge.
Pain Intensity Measured by the Numeric Rating Scale (NRS)
Pain intensity was assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Pain scores were compared between the stress ball intervention group and the routine care group.
Measured: 15 minutes after femoral catheter removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start30 May 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a single-center, two-arm, parallel-group randomized controlled trial. A total of 84 participants were randomly assigned in a 1:1 ratio to either the intervention group (n=42), which received a stress ball intervention during femoral catheter removal, or the control group (n=42), which received routine clinical care. Each participant remained in their assigned group throughout the study, with no crossover between groups.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Erdoğan, Maltepe University
- Investigators
- Hatice Erdoğan, Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889479
- Sponsor's protocol ID
- HE-STRESSBALL-CAG-2024
- Acronym
- SB-FCR
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect participant confidentiality and privacy. No individual participant data sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Use During Femoral Catheter Removal on Quality of Recovery, Comfort, and Pain Following Coronary Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07889479
- Acronym / sponsor ID
- SB-FCR / HE-STRESSBALL-CAG-2024
- Conditions
- Coronary Angiography
- Keywords
- Coronary Angiography, Femoral Catheter Removal, Stress Ball, Quality of Recovery, Patient Comfort, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 22 Oct 2026 (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 aimed to evaluate the effects of using a stress ball during femoral catheter removal on quality of recovery, patient comfort, and pain in adults undergoing coronary angiography.
The study was conducted at a hospital in Istanbul, Türkiye, between November 2024 and May 2025. A total of 84 patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups, with 42 patients in each group.
Patients in the intervention group were asked to repeatedly squeeze and release a stress ball during femoral catheter removal. Patients in the control group received routine clinical care without the stress ball intervention.
Pain was assessed 15 minutes after catheter removal. Quality of recovery and patient comfort were evaluated before discharge using standardized assessment scales.
The study was designed to determine whether stress ball use could improve recovery and comfort and reduce pain during care following coronary angiography.
Detailed description
Femoral catheter removal following coronary angiography may cause pain, discomfort, and anxiety, potentially affecting patients' recovery experiences. Simple, non-pharmacological nursing interventions may help improve patient comfort during this procedure.
This study was designed as a single-center, two-arm, parallel-group randomized controlled trial to investigate the effects of stress ball use during femoral catheter removal on quality of recovery, perianesthesia comfort, and pain.
Adult patients undergoing coronary angiography via femoral arterial access were randomly assigned to an intervention group or a control group. In the intervention group, patients were instructed to repeatedly squeeze a medium-firm silicone stress ball while counting to three and then release it during catheter removal. Patients in the control group received routine clinical care without the stress ball intervention.
Pain intensity was assessed using a Numerical Rating Scale 15 minutes after catheter removal. Quality of recovery and perianesthesia comfort were assessed using standardized scales before discharge.
The study evaluated whether this simple, low-cost, non-pharmacological intervention could improve patient-reported recovery and comfort and reduce pain associated with femoral catheter removal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a single-center, two-arm, parallel-group randomized controlled trial. A total of 84 participants were randomly assigned in a 1:1 ratio to either the intervention group (n=42), which received a stress ball intervention during femoral catheter removal, or the control group (n=42), which received routine clinical care. Each participant remained in their assigned group throughout the study, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Other: Stress Ball InterventionParticipants in the intervention group received routine clinical care and were instructed to use a medium-sized, medium-firm silicone stress ball during femoral catheter removal following coronary angiography. Participants repeatedly squeezed the stress ball while counting to three and then released it, continuing this procedure during catheter removal. |
| Control Group | No intervention | –Participants in the control group received routine clinical care during femoral catheter removal following coronary angiography. No stress ball intervention was administered. Pain intensity was assessed 15 minutes after catheter removal, while quality of recovery and perianesthesia comfort were evaluated before discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older.
- No communication difficulties that would prevent participation in the study.
- Adequate mental status to participate in the study.
- No physical limitations preventing the use of a stress ball.
- Underwent coronary angiography via femoral arterial access.
Key exclusion criteria (4 listed)
- Not meeting the inclusion criteria.
- Requesting withdrawal from the study at any stage.
- Being discharged before completion of data collection.
- Developing complications during the intervention or data collection process.
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 |
|---|---|---|
| Stress Ball InterventionParticipants assigned to the intervention group were instructed to use a medium-sized, medium-firm silicone stress ball during femoral catheter removal following coronary angiography. Participants repeatedly squeezed the stress ball while counting to three and then released it. This procedure was continued during catheter removal as a non-pharmacological nursing intervention. All participants also received routine clinical care. | Other | Stress Ball Group |
Primary outcome
Quality of Recovery-14 Scale (QoR-14)
Time frame: Once, at 24 hours after coronary angiography, immediately before hospital discharge.
Patient comfort was assessed using the 24-item Perianesthesia Comfort Scale (PCS), based on Kolcaba's Comfort Theory. Each item is rated on a 6-point Likert scale, with negatively worded items reverse-scored. Total scores range from 24 to 144, with higher scores indicating greater comfort.
2 secondary outcomes
Perianesthesia Comfort Scale (PCS)
Time frame: Once, at 24 hours after coronary angiography, immediately before hospital discharge.
Pain Intensity Measured by the Numeric Rating Scale (NRS)
Time frame: 15 minutes after femoral catheter removal.
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 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to protect participant confidentiality and privacy. No individual participant data sharing plan was established for this study.
Related trials for Coronary Angiography
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
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.
Hatice Erdoğan principal investigator
Maltepe 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 Stress Ball Intervention in people with Coronary Angiography, run by Maltepe 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 7 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 26 Oct 2026. 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?
Quality of Recovery-14 Scale (QoR-14) (time frame: Once, at 24 hours after coronary angiography, immediately before hospital 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 26 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.