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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05486533
Other study ID # MersinUnive
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2022
Est. completion date December 30, 2022

Study information

Verified date January 2023
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Turkey Turkey, Mersin University, Mersin Turkey/Mersin,Yenisehir

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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.

The effect of acupressure on vital signs, acute pain, stress and satisfaction during venipuncture: Single-blind, randomized controlled study. European

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary Systolic blood pressure Systolic blood pressure (SBP), mmHg Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary Diastolic blood pressure Diastolic blood pressure (DBP), mmHg Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary Heart rate Beats per minute Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary Respiratory rate Lung breathing Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
Secondary Peripheral oxygen saturation %, percentage of oxygenated hemoglobin in peripheral arterial blood Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation
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