Percutaneous Coronary InterventionNCT06445387
Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
A study testing Virtual Reality Glasses and Ice Application Group in people with Percutaneous Coronary Intervention and Virtual Reality, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Virtual Reality, Nursing Caries
- What is being tested?
- Virtual Reality Glasses and Ice Application Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2021to 4 Jan 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intervention in the femoral region,
- Femoral sheath size is 6-7 fr,
- Presence of only one sheath in the femoral region,
- No analgesics were administered before femoral sheath removal,
- Absence of serious bleeding and major hematoma in the femoral region,
- Being over 18 years of age,
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- No communication problems,
- Having a place and time orientation,
- No dizziness,
- Not having any psychiatric disease,
- No visual, auditory or mental problems,
- No previously identified cold allergy,
- Being willing and willing to participate in the study,
Who cannot join
- Serious bleeding and major hematoma development in the femoral region,
- Not applying intracoronary stent or coronary angioplasty after coronary angiography,
- Vital signs are abnormal enough to prevent intervention,
- Having visual, auditory and mental disabilities,
- Having a communication problem,
- Not being willing and able to participate in the study,
- It is defined as wanting to withdraw from the study at any stage of the study or being excluded from the study by the researcher.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University İnstitute of Health Sciences
Amasya, Merkez, 05100
About this study
Official title: The Effect of Virtual Reality Glasses and Ice Applıcatıon on the Level of Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.
Read the detailed description
After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).
Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.
Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.
Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.
The pain level of the patients was evaluated using a numerical rating scale;
- before the femoral sheath extraction (PAS1),
- during the femoral sheathing (SDQ2),
- immediately after the femoral sheathing (SDQ3),
- 30 minutes after the femoral sheathing (SDQ4) and
- 1 hour after the femoral sheathing (SDQ4). SDÖ5) was evaluated and recorded.
- Conditions
- Percutaneous Coronary Intervention, Virtual Reality, Nursing Caries, Cryotherapy, Pain Management
- Being tested
- Virtual Reality Glasses, Ice Application Group, Control Group
- Keywords
- Percutaneous Coronary Intervention, Virtual Reality, Pain Management, Nursing, Ice Application
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesOther
Also called Experimental
Preparation Stage of Virtual Glasses: A 20-minute video consisting of nature scenes shot with a 360-degree camera was selected by the researchers from YouTube. Permission was obtained from the person who created the video.
For the selection of music, both the music that is good for diseases were examined in the literature and an expert opinion was taken from a faculty member (Phd, assistant professor) working at the Faculty of Music and Fine Arts of a university. The music used in the video was created with works selected from the Hüseyni maqam.
Ice Application GroupOther
Also called Experimental
Features of the ice and ice bag used for patients in ice application; Ice cubes with dimensions of 9.5 x 26 x 3.5 cm were used. The ice bag is made of cotton and polyester coated fabric and is easily bendable. In this way, the ice bag was ensured to fit properly to the patient's femoral region. It is reusable and heat insulated. The procedure was carried out by following the cold application step protocol created by the researchers using the literature.
Control GroupOther
Also called Control
They continued to receive their routine treatment and care. No changes were made in their routine treatment and care.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses Gruop | Experimental | The procedure was tested for five minutes, one hour before application, to evaluate the patients' compliance and to detect any possible problems after wearing the glasses. In patients who did not experience any problems after the test, glasses were put on the patient just before the femoral sheath and remained on for 20 minutes. Receives: Other: Virtual Reality Glasses |
| Ice Application Group | Experimental | Before taking the femoral sheath, the researcher applied cold to the area where the femoral sheath was located with an ice pack for 20 minutes. A femoral sheath was performed immediately after the ice bag was removed. Receives: Other: Ice Application Group |
| Control Group | Other | The general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores: Numerical rating scale
The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time).
Measured: "through study completion, an average of 1 year".
Secondary outcomes (4)
Physiological parameter
Vital parameters (Pulse rate measured in minutes) of the patients were evaluated
Pulse rate was measured before femoral sheath removal (time 1) Pulse rate was measured during femoral sheath removal (2nd time) Pulse rate was measured immediately after femoral sheath removal (3rd time) Pulse rate was measured 30 minutes after femoral sheath removal (4th time) Pulse rate was measured 1 hour after femoral sheath removal (5th time
Measured: "through study completion, an average of 1 year".
Physiological parameter
Vital parameters (respiration-rate measured in minutes) of the patients were evaluated.
Respiration rate was measured before femoral sheath removal (time 1) Respiration rate was measured during femoral sheath removal (2nd time) Respiration rate was measured immediately after femoral sheath removal (3rd time) Respiration rate was measured 30 minutes after femoral sheath removal (4th time) Respiration rate was measured 1 hour after femoral sheath removal (5th time)
Measured: "through study completion, an average of 1 year".
Physiological parameter
Vital parameters (blood pressure-measured in mmHg) of the patients were evaluated
Blood pressure was measured before femoral sheath removal (time 1) Blood pressure was measured during femoral sheath removal (2nd time) Blood pressure was measured immediately after femoral sheath removal (3rd time) Blood pressure was measured 30 minutes after femoral sheath removal (4th time) Blood pressure was measured 1 hour after femoral sheath removal (5th time)
Measured: "through study completion, an average of 1 year".
Physiological parameter
Vital parameters (body temperature measured in degrees Centigrant) of the patients were evaluated
Body temperature was measured before femoral sheath removal (time 1) Body temperature was measured during femoral sheath removal (2nd time) Body temperature was measured immediately after femoral sheath removal (3rd time) Body temperature was measured 30 minutes after femoral sheath removal (4th time) Body temperature was measured 1 hour after femoral sheath removal (5th time)
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start12 Jul 2021
- Primary completion3 Nov 2022
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Model description
- It is a randomized controlled, single-blind, experimental study. Participants were assigned to three groups: intervention (virtual reality group and ice group) and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eylem Topbaş, Phd, Study director, Amasya University Faculty of Health ScienceGökhan KESKİN, Phd, Study director, Amasya University Faculty of Medical ScienceAycan SOYLU, Msc, Principal investigator, Amasya University Instutue of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445387
- Sponsor's protocol ID
- AU-SBE-ASoylu-03
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: starting in December 2025 Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Publications
Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.
PubMed 15297952Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002.
PubMed 9145556
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses and Ice Applıcatıon on the Level of Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
- ClinicalTrials.gov ID
- NCT06445387
- Acronym / sponsor ID
- AU-SBE-ASoylu-03
- Conditions
- Percutaneous Coronary Intervention, Virtual Reality, Nursing Caries, Cryotherapy, Pain Management
- Keywords
- Percutaneous Coronary Intervention, Virtual Reality, Pain Management, Nursing, Ice Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 6 Jun 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.
It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.
Detailed description
After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).
Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.
Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.
Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.
The pain level of the patients was evaluated using a numerical rating scale;
- before the femoral sheath extraction (PAS1),
- during the femoral sheathing (SDQ2),
- immediately after the femoral sheathing (SDQ3),
- 30 minutes after the femoral sheathing (SDQ4) and
- 1 hour after the femoral sheathing (SDQ4). SDÖ5) was evaluated and recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- It is a randomized controlled, single-blind, experimental study. Participants were assigned to three groups: intervention (virtual reality group and ice group) and control group.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses Gruop | Experimental | Other: Virtual Reality GlassesThe procedure was tested for five minutes, one hour before application, to evaluate the patients' compliance and to detect any possible problems after wearing the glasses. In patients who did not experience any problems after the test, glasses were put on the patient just before the femoral sheath and remained on for 20 minutes. |
| Ice Application Group | Experimental | Other: Ice Application GroupBefore taking the femoral sheath, the researcher applied cold to the area where the femoral sheath was located with an ice pack for 20 minutes. A femoral sheath was performed immediately after the ice bag was removed. |
| Control Group | Other | Other: Control GroupThe general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Intervention in the femoral region,
- Femoral sheath size is 6-7 fr,
- Presence of only one sheath in the femoral region,
- No analgesics were administered before femoral sheath removal,
- Absence of serious bleeding and major hematoma in the femoral region,
Key exclusion criteria (7 listed)
- Serious bleeding and major hematoma development in the femoral region,
- Not applying intracoronary stent or coronary angioplasty after coronary angiography,
- Vital signs are abnormal enough to prevent intervention,
- Having visual, auditory and mental disabilities,
- Having a communication problem,
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 |
|---|---|---|
| Virtual Reality GlassesAlso: ExperimentalPreparation Stage of Virtual Glasses: A 20-minute video consisting of nature scenes shot with a 360-degree camera was selected by the researchers from YouTube. Permission was obtained from the person who created the video. For the selection of music, both the music that is good for diseases were examined in the literature and an expert opinion was taken from a faculty member (Phd, assistant professor) working at the Faculty of Music and Fine Arts of a university. The music used in the video was created with works selected from the Hüseyni maqam. | Other | Virtual Reality Glasses Gruop |
| Ice Application GroupAlso: ExperimentalFeatures of the ice and ice bag used for patients in ice application; Ice cubes with dimensions of 9.5 x 26 x 3.5 cm were used. The ice bag is made of cotton and polyester coated fabric and is easily bendable. In this way, the ice bag was ensured to fit properly to the patient's femoral region. It is reusable and heat insulated. The procedure was carried out by following the cold application step protocol created by the researchers using the literature. | Other | Ice Application Group |
| Control GroupAlso: ControlThey continued to receive their routine treatment and care. No changes were made in their routine treatment and care. | Other | Control Group |
Primary outcome
Pain Scores: Numerical rating scale
Time frame: "through study completion, an average of 1 year".
The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time).
4 secondary outcomes
Physiological parameter
Time frame: "through study completion, an average of 1 year".
Physiological parameter
Time frame: "through study completion, an average of 1 year".
Physiological parameter
Time frame: "through study completion, an average of 1 year".
Physiological parameter
Time frame: "through study completion, an average of 1 year".
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 6 Jun 2024.
- Results publication: PubMed 15297952Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.
- Results publication: PubMed 9145556Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002.
- Individual participant dataSharing planned: No. starting in December 2025 Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
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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.
Eylem Topbaş, Phd study director
Amasya University Faculty of Health Science
Gökhan KESKİN, Phd study director
Amasya University Faculty of Medical Science
Aycan SOYLU, Msc principal investigator
Amasya University Instutue of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses and Ice Application Group in people with Percutaneous Coronary Intervention and Virtual Reality, run by Amasya 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 13 inclusion and 7 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 6 Jun 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?
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 Scores: Numerical rating scale (time frame: "through study completion, an average of 1 year".). 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 NCT06445387, which also lists 2 linked publications.
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 6 Jun 2024.