Coronary Artery DiseaseNCT05381246
The Effect of Reiki and Acupressure on Pain, Anxiety and Vital Signs
A study testing Acupressure and Reiki in people with Coronary Artery Disease, run by Mersin University.
Trial summary
This research aims to determine the effects of reiki and acupressure applied after percutaneous coronary intervention on pain, anxiety and vital signs during femoral catheter extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Acupressure and Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 15 Nov 2022
- 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
- 18 years and over,
- Percutaneous coronary intervention (PCI) for the first time,
- Previously planned PCI (elective patients),
- No additional procedure to percutaneous coronary intervention,
- Awake and conscious during percutaneous coronary intervention (not taking sedatives)
- A single sandbag is placed on the intervention area,
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- Able to lie flat on his back (without respiratory distress),
- Hemodynamically stable (absence of chest pain and arrhythmia),
- No analgesic drug administered at least four hours before,
- No complications such as hematoma or bleeding in the operation area,
- No deformity or lesion in the areas where acupressure will be applied,
- No previous experience of acupressure and reiki application,
- Not diagnosed with anxiety disorder and not receiving medical treatment,
- Literate,
- Have sufficient communication skills and
- Those who signed the Informed Consent Form to participate
Who cannot join
- Emergency patients whose PCI was not planned beforehand,
- Bleeding, hematoma, etc. at the femoral intervention site during and after the procedure. developing complications,
- Any deformity, wound or lesion in the areas where acupressure will be applied,
- Coronary angiography only,
- Thrombocyte level less than 100,000 mg/dl,
- Those who did not sign the Informed Consent Form to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Reiki and Acupressure Applied After Percutaneous Coronary Intervention on Pain, Anxiety and Vital Signs During Femoral Catheter Extraction: A Randomized Controlled Trial.
This research aims to determine the effects of reiki and acupressure applied after percutaneous coronary intervention on pain, anxiety and vital signs during femoral catheter extraction.
Read the detailed description
In this study, 84 patients with percutaneous coronary intervention were assigned to the reiki, acupressure and control groups by block randomization method.In the acupressure group (n=28) the heart meridian 7th point (HT7) large intestine meridian 4th point (LI4) and pericardial meridian 6th point (PC6) will be applied to a total of three points.Depending on the preparation and compression time on each point, the session duration of each patient will be 18 minutes on average.In the reiki group (n=28) the crown chakra (top of the head), the forehead chakra (above the forehead), the throat chakra (above the throat), the heart chakra (the middle of the chest), the solar plexus (under the chest, above the navel), the sacral chakra (below the navel) and the root chakra (above the coccyx) will be applied to the region of the 7 chakra points on.In the reiki group, the reiki application time will take 21 minutes on average.Routine care will be applied to the control group (n=28).Pre-test data of patients in the acupressure, reiki and control groups will be collected 30 minutes before femoral catheter extraction after percutaneous coronary. Posttest data will be collected five minutes after femoral catheter extraction.
Data will be collected using the "Personal Information Form", "Visual Analog Scale", "State Anxiety Inventory" and "Vital Signs Evaluation Form".
- Conditions
- Coronary Artery Disease
- Being tested
- Acupressure, Reiki
- Keywords
- Percutaneous Coronary Intervention, Acupressure, Reiki, Pain, Anxiety, Vital Signs
- Medical subject headings
- Coronary Artery Disease, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
In the acupressure group, heart meridian 7th point (HT7), large intestine meridian 4th point, and pericardial meridian 6th point (PC6) will be applied. Tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Subsequently, consecutive (breathing rhythm) compressions will be applied to the acupressure points determined by the researcher, without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief Since the symmetry of the selected three different points will also be applied to the other extremity, a total of 18 minutes of compression will be applied to each point, provided that it is three minutes.
ReikiOther
In the reiki group, the crown chakra (top of the head), the forehead chakra (above the forehead), the throat chakra (above the throat), the heart chakra (the middle of the chest), the solar plexus (under the chest, above the navel), the sacral chakra (below the navel) and the root chakra (above the coccyx) will be applied to the region of the 7 chakra points on.In the reiki group, the reiki application time will take 21 minutes on average.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | A total of 18 minutes of compression will be applied to each point for three minutes, as the Heart Meridian is at the 7th point (HT7), the Large Intestine Meridian is at the 4th point (LI4) and the pericardial meridian is at the 6th point (PC6). Receives: Other: Acupressure |
| Reiki group | Experimental | In the reiki group the crown chakra (top of the head), the forehead chakra (above the forehead), the throat chakra (above the throat), the heart chakra (the middle of the chest), the solar plexus (under the chest, above the navel), the sacral chakra (below the navel) and the root chakra (above the coccyx) will be applied to the region of the 7 chakra points on.In the reiki group, the reiki application time will take 21 minutes on average. Receives: Other: Reiki |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using the Visual Analog Scale
The scale consists of a 10 cm ruler on which there is no pain on one end and excruciating pain on the other, on which the patient marks the pain. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded.
Measured: 30 minutes
Anxiety evaluated using the State Anxiety Inventory
The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start15 May 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Avcı, Mersin University
- Investigators
- Meral Gün, Doctorate, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381246
- Sponsor's protocol ID
- MERSİN-AVCI-001
- Status last verified
- May 2022
- First submitted
- 14 May 2022
- Last updated
- 19 May 2022
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki and Acupressure Applied After Percutaneous Coronary Intervention on Pain, Anxiety and Vital Signs During Femoral Catheter Extraction: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05381246
- Acronym / sponsor ID
- MERSİN-AVCI-001
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Acupressure, Reiki, Pain, Anxiety, Vital Signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 19 May 2022 (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 research aims to determine the effects of reiki and acupressure applied after percutaneous coronary intervention on pain, anxiety and vital signs during femoral catheter extraction.
Detailed description
In this study, 84 patients with percutaneous coronary intervention were assigned to the reiki, acupressure and control groups by block randomization method.In the acupressure group (n=28) the heart meridian 7th point (HT7) large intestine meridian 4th point (LI4) and pericardial meridian 6th point (PC6) will be applied to a total of three points.Depending on the preparation and compression time on each point, the session duration of each patient will be 18 minutes on average.In the reiki group (n=28) the crown chakra (top of the head), the forehead chakra (above the forehead), the throat chakra (above the throat), the heart chakra (the middle of the chest), the solar plexus (under the chest, above the navel), the sacral chakra (below the navel) and the root chakra (above the coccyx) will be applied to the region of the 7 chakra points on.In the reiki group, the reiki application time will take 21 minutes on average.Routine care will be applied to the control group (n=28).Pre-test data of patients in the acupressure, reiki and control groups will be collected 30 minutes before femoral catheter extraction after percutaneous coronary. Posttest data will be collected five minutes after femoral catheter extraction.
Data will be collected using the "Personal Information Form", "Visual Analog Scale", "State Anxiety Inventory" and "Vital Signs Evaluation Form".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureA total of 18 minutes of compression will be applied to each point for three minutes, as the Heart Meridian is at the 7th point (HT7), the Large Intestine Meridian is at the 4th point (LI4) and the pericardial meridian is at the 6th point (PC6). |
| Reiki group | Experimental | Other: ReikiIn the reiki group the crown chakra (top of the head), the forehead chakra (above the forehead), the throat chakra (above the throat), the heart chakra (the middle of the chest), the solar plexus (under the chest, above the navel), the sacral chakra (below the navel) and the root chakra (above the coccyx) will be applied to the region of the 7 chakra points on.In the reiki group, the reiki application time will take 21 minutes on average. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18 years and over,
- Percutaneous coronary intervention (PCI) for the first time,
- Previously planned PCI (elective patients),
- No additional procedure to percutaneous coronary intervention,
- Awake and conscious during percutaneous coronary intervention (not taking sedatives)
Key exclusion criteria (6 listed)
- Emergency patients whose PCI was not planned beforehand,
- Bleeding, hematoma, etc. at the femoral intervention site during and after the procedure. developing complications,
- Any deformity, wound or lesion in the areas where acupressure will be applied,
- Coronary angiography only,
- Thrombocyte level less than 100,000 mg/dl,
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 |
|---|---|---|
| AcupressureIn the acupressure group, heart meridian 7th point (HT7), large intestine meridian 4th point, and pericardial meridian 6th point (PC6) will be applied. Tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Subsequently, consecutive (breathing rhythm) compressions will be applied to the acupressure points determined by the researcher, without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief Since the symmetry of the selected three different points will also be applied to the other extremity, a total of 18 minutes of compression will be applied to each point, provided that it is three minutes. | Other | Acupressure group |
| ReikiIn the reiki group, the crown chakra (top of the head), the forehead chakra (above the forehead), the throat chakra (above the throat), the heart chakra (the middle of the chest), the solar plexus (under the chest, above the navel), the sacral chakra (below the navel) and the root chakra (above the coccyx) will be applied to the region of the 7 chakra points on.In the reiki group, the reiki application time will take 21 minutes on average. | Other | Reiki group |
Primary outcome
Pain evaluated using the Visual Analog Scale
Time frame: 30 minutes
The scale consists of a 10 cm ruler on which there is no pain on one end and excruciating pain on the other, on which the patient marks the pain. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded.
Anxiety evaluated using the State Anxiety Inventory
Time frame: 30 minutes
The scale consists of 20 statements. The total score can range from 20 to 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- 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.
Meral Gün, Doctorate study director
Mersin University
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Reiki in people with Coronary Artery Disease, run by Mersin University.
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 16 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Abdullah Avcı, Master (+90 324 241 00 00 ext. 22921, abdullahavci@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluated using the Visual Analog Scale (time frame: 30 minutes). 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 19 May 2022.