Effect of Progressive Relaxation ExerciseNCT06871332
Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction
A study testing Progressive relaxation exercise group in people with Effect of Progressive Relaxation Exercise, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Progressive Relaxation Exercise
- What is being tested?
- Progressive relaxation exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2023to 5 Apr 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
- able to speak and understand Turkish,
- over 18 years of age,
- intervened in the femoral region,
- with only one catheter in the femoral region,
- without vision and hearing problems,
- undergoing angiography procedure for the first time,
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- with normal vital signs,
- who have not been administered analgesics for any reason prior to sheath removal after the procedure,
- patients who volunteered to participate in the study were included in the study.
Who cannot join
- patients with chronic pain using transdermal patches,
- patients with impaired time and place orientation,
- patients with psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction Related to Femoral Sheath Removal: a Randomized Controlled Study
This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.
Read the detailed description
This study aimed to determine the effect of progressive relaxation exercise (PRE) applied to patients undergoing percutaneous coronary intervention (PCI) on pain, anxiety and patient satisfaction related to femoral sheath removal. This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed PRE for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.
- Being tested
- Progressive relaxation exercise group
- Keywords
- Anxiety, Femoral Sheath, Pain, Progressive Relaxation Exercise, Satisfaction
- Medical subject headings
- Anxiety Disorders, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercise groupOther
Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal.
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation exercises group | Experimental | Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. Receives: Other: Progressive relaxation exercise group |
| Control group | No intervention | The patients in the control group received the standard practice of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Patients' pain is evaluated with the Visual Analog Scale (VAS) .The VAS is a 10 cm long ruler drawn horizontally or vertically. Patients were told that 0 on the scale means no pain and 10 means unbearable pain at the highest level. The patient was asked to mark the point on this scale indicating the level of pain they felt.
Measured: One minute after femoral sheath removal
Anxiety level
Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. patients were told that 0 on the scale means no anxiety and 10 means unbearable anxiety at the highest level. The patient was asked to mark the point on this scale indicating the level of anxiety they felt.
Measured: One minute after femoral sheath removal
Patient satisfaction
Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. It was explained to the patient that the number 0 indicated no satisfaction with the application and the number 10 indicated the highest level of satisfaction and the patient was asked to mark on the ruler.
Measured: One minute after sheath removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start2 Aug 2023
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Progressive Relaxation ExerciseStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871332
- Sponsor's protocol ID
- 2022/543
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korkut S, Oguzhan A. The Effect of Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction Related to Femoral Sheath Removal: A Randomized Controlled Study. Catheter Cardiovasc Interv. 2025 Dec;106(7):3714-3721. doi: 10.1002/ccd.70258. Epub 2025 Oct 13.
PubMed 41078153
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction Related to Femoral Sheath Removal: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06871332
- Acronym / sponsor ID
- 2022/543
- Keywords
- Anxiety, Femoral Sheath, Pain, Progressive Relaxation Exercise, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 11 Mar 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 single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.
Detailed description
This study aimed to determine the effect of progressive relaxation exercise (PRE) applied to patients undergoing percutaneous coronary intervention (PCI) on pain, anxiety and patient satisfaction related to femoral sheath removal. This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed PRE for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation exercises group | Experimental | Other: Progressive relaxation exercise groupPatients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. |
| Control group | No intervention | –The patients in the control group received the standard practice of the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- able to speak and understand Turkish,
- over 18 years of age,
- intervened in the femoral region,
- with only one catheter in the femoral region,
- without vision and hearing problems,
Key exclusion criteria (3 listed)
- patients with chronic pain using transdermal patches,
- patients with impaired time and place orientation,
- patients with psychiatric disorders.
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 |
|---|---|---|
| Progressive relaxation exercise groupPatients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. | Other | Progressive relaxation exercises group |
Primary outcome
Pain level
Time frame: One minute after femoral sheath removal
Patients' pain is evaluated with the Visual Analog Scale (VAS) .The VAS is a 10 cm long ruler drawn horizontally or vertically. Patients were told that 0 on the scale means no pain and 10 means unbearable pain at the highest level. The patient was asked to mark the point on this scale indicating the level of pain they felt.
Anxiety level
Time frame: One minute after femoral sheath removal
Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. patients were told that 0 on the scale means no anxiety and 10 means unbearable anxiety at the highest level. The patient was asked to mark the point on this scale indicating the level of anxiety they felt.
Patient satisfaction
Time frame: One minute after sheath removal
Patients' anxiety is evaluated with the Visual Analog Scale (VAS). The VAS is a 10 cm long ruler drawn horizontally or vertically. It was explained to the patient that the number 0 indicated no satisfaction with the application and the number 10 indicated the highest level of satisfaction and the patient was asked to mark on the ruler.
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 11 Mar 2025.
- Derived from this study: PubMed 41078153Korkut S, Oguzhan A. The Effect of Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction Related to Femoral Sheath Removal: A Randomized Controlled Study. Catheter Cardiovasc Interv. 2025 Dec;106(7):3714-3721. doi: 10.1002/ccd.70258. Epub 2025 Oct 13.
- 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 Progressive relaxation exercise group in people with Effect of Progressive Relaxation Exercise, run by TC Erciyes 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 9 inclusion and 3 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 11 Mar 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?
Pain level (time frame: One minute after femoral sheath removal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06871332, which also lists 1 linked publication.
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 11 Mar 2025.