NCT05381246

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable coronary-artery-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 14, 2022

Last Update Submit

May 14, 2022

Conditions

Keywords

Percutaneous Coronary InterventionAcupressureReikiPainAnxietyVital Signs

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

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).

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.

Other: Reiki

Control group

NO INTERVENTION

Interventions

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.

Acupressure group
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.

Reiki group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseasePainAnxiety Disorders

Interventions

AcupressureTherapeutic Touch

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body TherapiesSpiritual Therapies

Study Officials

  • Meral Gün, Doctorate

    Mersin University

    STUDY DIRECTOR

Central Study Contacts

Abdullah Avcı, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing researcher

Study Record Dates

First Submitted

May 14, 2022

First Posted

May 19, 2022

Study Start

May 15, 2022

Primary Completion

August 15, 2022

Study Completion

November 15, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share