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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05381246
Other study ID # MERSIN-AVCI-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2022
Est. completion date November 15, 2022

Study information

Verified date May 2022
Source Mersin University
Contact Abdullah Avci, Master
Phone +90 324 241 00 00
Email abdullahavci@mersin.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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".


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date November 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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, - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupressure
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.
Reiki
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes
Primary 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. 30 minutes
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