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

Sponsor

Mersin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05486533

Collaborator

(none)

124

Enrollment

Location

Arms

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acupressure Pain Hemodynamic Instability Angiopathy, Peripheral	Other: Acupressure	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, parallel, three-arm randomized controlled clinical trialProspective, parallel, three-arm randomized controlled clinical trial

Masking:

Single (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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental The experimental group will be given acupressure.	Other: Acupressure 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. Other Names: Acupress
No Intervention: Control It will only take routine treatment and care.

Arm

Intervention/Treatment

Experimental: Experimental

The experimental group will be given acupressure.

Other: Acupressure

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.

Other Names:

Acupress

No Intervention: Control

It will only take routine treatment and care.

Outcome Measures

Primary Outcome Measures

Pain evaluated using the visual analog scale [Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation]
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 [Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation]
Systolic blood pressure (SBP), mmHg
Diastolic blood pressure [Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation]
Diastolic blood pressure (DBP), mmHg
Heart rate [Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation]
Beats per minute
Respiratory rate [Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation]
Lung breathing
Peripheral oxygen saturation [Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation]
%, percentage of oxygenated hemoglobin in peripheral arterial blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turkey, Mersin University,	Mersin	Turkey/Mersin,Yenişehir	Turkey	33343

Sponsors and Collaborators

Mersin University

Investigators

Study Director: Gülay Altun Uğraş, PhD, Mersin University
Principal Investigator: Canan KANAT, Master, Mersin University
Principal Investigator: Barış DÜZEL, Specialist, Mersin City Research and Application Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Tugba CAM YANIK, Principal Investigator, Mersin University

ClinicalTrials.gov Identifier:

NCT05486533

Other Study ID Numbers:

MersinUnive

First Posted:

Aug 3, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Vascular Diseases

Peripheral Arterial Disease

Study Results

No Results Posted as of Aug 5, 2022