NCT05350397

Brief Summary

Atrial fibrillation is a common cardiac arrhythmia affecting 1-2% of the population. This rate is expected to increase in the next 30 years. The aim of this study is to determine the effect of acupressure applied to patients with chronic atrial fibrillation on blood pressure and heart rate. This study was designed as a randomized, placebo-controlled experimental study. As a result of the power analysis, 3 groups were formed, each consisting of 23 subjects. No procedure was applied to the control group before and after the measurements. In patients in the placebo group, an inverted and loose acupressure wristband was attached to the Shenman point to avoid applying pressure to any part of the wrist. Acupressure wristbands were applied towards the Shenmen point to provide adequate pressure to the patients in the intervention group and acupressure was applied twice a day. Acupressure was applied 4 times in two days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable atrial-fibrillation

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

April 6, 2022

Last Update Submit

March 24, 2023

Conditions

Keywords

Acupressureatrial fibrillationblood pressureheart raterandomized controlled trialnursing care

Outcome Measures

Primary Outcomes (1)

  • Investigation of the effect of acupressure applied to patients with Atrial Fibrillation on systole blood pressure, diastolic blood pressure and heart rate

    The first criterion was planned to examine and report the effect of acupressure on systole blood pressure.

    6 months

Secondary Outcomes (1)

  • Investigation of the effect of acupressure applied to patients with Atrial Fibrillation on systole blood pressure, diastolic blood pressure and heart rate

    6 months

Other Outcomes (1)

  • Investigation of the effect of acupressure applied to patients with Atrial Fibrillation on systole blood pressure, diastolic blood pressure and heart rate

    6 months

Study Arms (3)

Acupressure group

EXPERIMENTAL

The patients in the intervention group were informed about what acupressure was and why it was applied. An acupressure wristband was correctly worn on both wrists to provide patients with adequate pressure on the HT7 point for 5 minutes

Other: How Important Is Acupress Applyıng In Atrıal Fıbrılatıon Treatment?

Placebo Group

PLACEBO COMPARATOR

Patients in the placebo group were informed about what acupressure was and why it was applied. In order not to apply pressure to the Shenmen (HT7) pressure point in the patients in this group, the acupressure wristband was placed on both wrists in an inverted and loose manner and the wristband was worn for 5 minutes, the procedure was completed.

Other: How Important Is Acupress Applyıng In Atrıal Fıbrılatıon Treatment?

Control group

NO INTERVENTION

No procedure was applied to the patients in the control group. The patients received routine treatment and care.

Interventions

The acupressure wristband was correctly attached to the Experimental Group and acupressure was applied. The placebo group was fitted with an inverted and loose acupressure wristband. No intervention was applied to the control group.

Acupressure groupPlacebo Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age
  • Fully conscious
  • Oriented and cooperative
  • Heart rate of 70-120 beats/min
  • No history of recent open heart surgery

You may not qualify if:

  • Patients with renal failure (which causes deterioration of heart rhythm and structure)
  • Liver failure (which affects hemodynamic balance)
  • Hyperthyroidism (increased pulse rate) were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KahramanmarasSIU

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Groups with the same trait random, independent, random, application and separated as the control group. Intervention is applied to a group, others are not interfered with, the results are followed by are compared. It was performed as a single-blind, pretest-posttest placebo, randomized, parallel-controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 28, 2022

Study Start

February 20, 2018

Primary Completion

February 20, 2018

Study Completion

July 20, 2018

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations