NCT06300294

Brief Summary

This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS). H1-1: Acupressure applied to individuals with ACS has an effect on blood pressure. H1-2: Acupressure applied to individuals with ACS has an effect on heart rate. H1-3: Acupressure applied to individuals with ACS has an effect on respiratory rate. H1-4: Acupressure applied to individuals with ACS has an effect on pain levels. H1-5: Acupressure applied to individuals with ACS has an effect on anxiety levels. H1-6: Acupressure applied to individuals with ACS has an effect on cortisol levels. H1-7: Acupressure applied to individuals with ACS has an effect on ECG changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

February 14, 2024

Last Update Submit

May 19, 2026

Conditions

Keywords

Acupressure, Anxiety, Vital Signs, acute coronary syndrome

Outcome Measures

Primary Outcomes (4)

  • means of blood pressure

    In this study, blood pressure was measured using monitors in the intensive care unit.

    up to 30 minutes

  • means of hear rate

    Heart rate is the pressure exerted on the vessel wall by the blood thrown by the left ventricle from the skin surface to the aorta during systole. In the research, heart rate is measured using a monitor.

    up to 30 minutes

  • means of respiratory rate

    Respiratory rate is the patient's breaths per minute. In this study, respiratory rate was taken from the monitor.

    up to 30 minutes

  • means of cortisol.

    The cortisol value in the blood will be measured.

    up to 60 minutes

Secondary Outcomes (3)

  • means of subjective anxiety scores.

    up to 30 minutes

  • means of subjective pain scores.

    up to 30 minutes

  • electrocardiography evaluation

    up to 30 minutes

Study Arms (2)

acupressure

EXPERIMENTAL

acupressure application and Routine care and treatment (filling out the initial hospitalization documents, measuring vital signs, taking an ECG, preparing for the CAG procedure, administering the ordered medications).

Other: acupressure

control

NO INTERVENTION

Routine care and treatment (filling out the initial hospitalization documents, measuring vital signs, taking an ECG, preparing for the CAG procedure, administering the ordered medications).

Interventions

* First follow-up (first 0-30 minutes of admission): Participants received routine care and treatment within the first 0-30 minutes of admission, in accordance with hospital protocol. * Second follow-up (6 hours after the CAG procedure): After the coronary angiography procedure was completed (after the sandbag was removed), the first acupressure application was performed on individuals whose vital signs were within the normal range. * Third follow-up (12 hours after the CAG procedure): Approximately 12 hours after the coronary angiography procedure, the second acupressure application was performed on individuals. * Fourth follow-up (Cortisol measurement): The fourth follow-up was conducted at 8:00 a.m. (sunrise) to determine cortisol levels. Physiological parameters were evaluated, and a venous blood sample was taken to determine cortisol levels.

acupressure

Eligibility Criteria

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

You may qualify if:

  • Volunteer to participate in the study,
  • Those aged 18 and over
  • Able to speak Turkish
  • Diagnosed with ACS for the first time
  • Cardiopulmonary resuscitation not applied
  • No orientation problems (those who score 15 on the Glasgow Coma Scale)
  • Not diagnosed with psychiatric disease
  • No amputation, fistula, lymphedema, neuropathy or hemiplegia in any of the Upper Extremities
  • Those who underwent femoral intervention for CAG procedure
  • Those who have not used any integrative practices based on pressure and stimulation such as acupressure, acupuncture and reflexology in the last month.
  • Vital signs (28) are within normal range:
  • Blood pressure: 90/60-120/80 mmHg Heart rate: 60-100 min Respiratory rate: 12-18 min

You may not qualify if:

  • Those with arrhythmia (AF, VT etc.)
  • Patients who have previously undergone Coronary Angiography
  • Diagnosed with myocarditis, pericarditis
  • Those who do not take any speed-breaking drugs (beloc, arlec, etc.).
  • Patients who underwent radial intervention for CAG procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa City Hospital

Manisa, 45000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Coronary SyndromeAnxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • aynur açıkgöz, PhD student

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The study protocol was developed using SPIRIT guidelines. Research reporting was structured according to the CONSORT checklist. To prevent selection bias in this study, participants were randomly assigned to intervention and control groups using block randomization. Because the researcher was also the administrator, blinding was not possible. However, the use of block randomization maintained balance between groups and prevented the prediction of group information in the early stages of the study. In this context, the researcher and the participants were blinded to their assignment to the group during the initial data collection process. Furthermore, to maintain objectivity during the data analysis process, the data analyst was not informed of the group assignments. All data were entered into the analysis program as "Group 1" and "Group 2," thus preventing any bias based on information.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: experimental and control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR DOCTOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 8, 2024

Study Start

May 5, 2024

Primary Completion

April 1, 2025

Study Completion

May 31, 2025

Last Updated

May 22, 2026

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations