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The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables (Acupress)

Primary Purpose

Acupressure, Pain, Hemodynamic Instability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acupressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Agreeing to participate in the research (signing the Informed Consent Form),
  • Conscious and cooperative,
  • Speaks and understands Turkish,
  • Over 18 years of age,
  • Stable general condition,
  • No sensitivity in the area where acupressure will be applied,
  • No active COVID-19 infection,
  • Patients without any psychiatric diagnosis will be included.

Exclusion Criteria:

  • Do not agreeing to participate in the research (signing the Informed Consent Form),
  • Do not conscious and cooperative,
  • Do not speaks and understands Turkish,
  • Do not over 18 years of age,
  • Do not stable general condition,
  • Having sensitivity in the area where acupressure will be applied,
  • Having active COVID-19 infection,
  • Patients with any psychiatric diagnosis will be included.

Sites / Locations

  • Turkey, Mersin University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

The experimental group will be given acupressure.

It will only take routine treatment and care.

Outcomes

Primary Outcome Measures

Pain evaluated using the visual analog scale
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.

Secondary Outcome Measures

Systolic blood pressure
Systolic blood pressure (SBP), mmHg
Diastolic blood pressure
Diastolic blood pressure (DBP), mmHg
Heart rate
Beats per minute
Respiratory rate
Lung breathing
Peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood

Full Information

First Posted
August 1, 2022
Last Updated
January 17, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05486533
Brief Title
The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables
Acronym
Acupress
Official Title
The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.
Detailed Description
In the study, 124 patients will randomly assigned to acupressure/experimental group and control group. To the acupressure/experimental group (n = 62), an average of 15 minutes will be applied to the LI4 (liver, between thumb and forefinger), P6 (pericardium, three fingers above the wrist) and LI 11 is located the area where the elbow bend. On the other hand, no other intervention will be applied to the control group other than routine treatment and nursing care. The primary outcome of the research is the effect of acupressure on the pain of patients. The secondary outcome of the study is to determine the effect of acupressure on the hemodynamic variables. The pain and hemodynamic variables will be collected before, immediately after the application, 10th, 20th and 30th minutes after the application. Data will also be collected from the control group at the same time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupressure, Pain, Hemodynamic Instability, Angiopathy, Peripheral

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel, three-arm randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
Due to the nature of the research, participants and researchers cannot be blinded. Analyzes will be made by a biostatistician independent of the research and the statistician will be blinded.
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will be given acupressure.
Arm Title
Control
Arm Type
No Intervention
Arm Description
It will only take routine treatment and care.
Intervention Type
Other
Intervention Name(s)
Acupressure
Other Intervention Name(s)
Acupress
Intervention Description
The experimental group will start with LI4 points and continue P6 and LI11 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.
Primary Outcome Measure Information:
Title
Pain evaluated using the visual analog scale
Description
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.
Time Frame
Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure (SBP), mmHg
Time Frame
Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Title
Diastolic blood pressure
Description
Diastolic blood pressure (DBP), mmHg
Time Frame
Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Title
Heart rate
Description
Beats per minute
Time Frame
Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Title
Respiratory rate
Description
Lung breathing
Time Frame
Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Title
Peripheral oxygen saturation
Description
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Time Frame
Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agreeing to participate in the research (signing the Informed Consent Form), Conscious and cooperative, Speaks and understands Turkish, Over 18 years of age, Stable general condition, No sensitivity in the area where acupressure will be applied, No active COVID-19 infection, Patients without any psychiatric diagnosis will be included. Exclusion Criteria: Do not agreeing to participate in the research (signing the Informed Consent Form), Do not conscious and cooperative, Do not speaks and understands Turkish, Do not over 18 years of age, Do not stable general condition, Having sensitivity in the area where acupressure will be applied, Having active COVID-19 infection, Patients with any psychiatric diagnosis will be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülay Altun Uğraş, PhD
Organizational Affiliation
Mersin University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Canan KANAT, Master
Organizational Affiliation
Mersin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barış DÜZEL, Specialist
Organizational Affiliation
Mersin City Research and Application Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turkey, Mersin University,
City
Mersin
State/Province
Turkey/Mersin,Yenişehir
ZIP/Postal Code
33343
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Rajaee, N., Choopani, N., Pishgoei, A. H., & Sharififar, S. (2015). The effect of acupressure on Patient's anxiety who candidate for coronary angiography. Military Caring Sciences, 1 (3), 6-13.
Results Reference
background
Citation
The effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European
Results Reference
result

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The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables

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