Back to results

The Effect of Reiki and Acupressure on Pain, Anxiety and Vital Signs

Primary Purpose

Coronary Artery Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Acupressure

Reiki

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Acupressure, Reiki, Pain, Anxiety, Vital Signs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Acupressure group

Reiki group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05381246

First Posted

May 14, 2022

Last Updated

May 14, 2022

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT05381246

Brief Title

The Effect of Reiki and Acupressure on Pain, Anxiety and Vital Signs

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 15, 2022 (Anticipated)

Primary Completion Date

August 15, 2022 (Anticipated)

Study Completion Date

November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention, Acupressure, Reiki, Pain, Anxiety, Vital Signs

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupressure group

Arm Type

Experimental

Arm Description

Arm Title

Reiki group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Acupressure

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Reiki

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain evaluated using the Visual Analog Scale

Description

Time Frame

30 minutes

Title

Anxiety evaluated using the State Anxiety Inventory

Description

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.

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abdullah Avcı, Master

Phone

+90 324 241 00 00

Ext

22921

abdullahavci@mersin.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meral Gün, Doctorate

Organizational Affiliation

Mersin University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of Reiki and Acupressure on Pain, Anxiety and Vital Signs

We'll reach out to this number within 24 hrs