The Effect of Acupressure on Acute Pain, Stress and Satisfaction During Venipuncture

December 10, 2020 updated by: DİLEK YILDIRIM, Istanbul Sabahattin Zaim University

The Effect of Acupressure on Acute Pain, Stress and Satisfaction During Venipuncture : Single-blind, Randomised Controlled Study

Acupressure, which is a type of nonpharmacological practice. Acupressure is a practice that provides energy flow by applying pressure to the special points of the meridians that innately carry energy in the body with stimulation bands, hands, and fingers. Acupressure is also known as acupuncture without needles. Because no needles are used in acupressure, acupressure is an easy, safe, effective, and economical method to learn and apply. There is no study to determine the effect of acupressure on acute pain, patient satisfaction and stress, which is applied to adult patients during the venipuncture procedure. In this context, the study was planned to be conducted in a randomized controlled trial to evaluate the effect of acupressure on acute pain, stress level and satisfaction during venpuncture in adult patients.Patient Evaluation Form, Visual Analogue Scale (VAS), Visual Patient Satisfaction Scale and State Anxiety Inventory will be used in the study. The scales will be used before and after venpuncture. Acupressure will be applied to the adults in the acupressure group for 10 min before the venipuncture procedure. Pain, heart rate, and oxygen saturation levels of the adults in the acupressure and control groups will be evaluated both before and after the venipuncture procedure.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Patients will be assigned to acupressure and control groups according to the randomization list prepared earlier by the investigators.

First of all, all patients will be informed about the procedure and their informed consent will be obtained. Patients in the acupuncture and control groups will be evaluated with the patient evaluation form, VAS and State Anxiety Inventory 15 minutes before venipuncture. Demographic information of each patient will be recorded by the investigator. The pain level, satisfaction level and anxiety levels of the patients will be recorded before the venipuncture procedure. The following applications will be made 10 minutes before the patients in the acupressure group. Hands are washed before applying acupressure. Before applying acupressure, the patient is allowed to sit in a comfortable position on the sofa in the single venipuncture room. Before starting the acupressure application, the arm is rubbed from fingertips to the elbow to relax, and press the acupressure points (Large Intestine Meridian 4th Point [LI 4], Large Intestine Meridian 11th Point [LI 11], and Heart Meridian 7th Point [HT 7]). application is carried out. 2 minutes to each acupressure point. pressure (3 to 5 kg of pressure) is applied. Only one acupressure session is performed for each patient, and each acupressure session will last 10 minutes (WHO, 2008). Acupressure application is applied before venipuncture. Venipuncturen is performed immediately after the acupressure session. While performing the acupuncture procedure and venipuncture, other patients participating in the study will not see each other during the application phase. Venipuncture will be applied to all patients by the same nurse in the same room. Venipuncture will be performed on the left arm of all patients with a vacuum tube using a 0.8 * 38 mm (21G x 1½, green) needle tip. Immediately after the venipuncture, the pain and satisfaction assessment of the patients during the procedure will be made with the VAS (Pain and Satisfaction) and State Anxiety Inventory. The pain level, satisfaction level and anxiety levels of the patients will be recorded before the venipuncture procedure. All of the measurement results were obtained by another researcher blinded to group allocation. All procedures will take approximately 20-25 minutes for each participant.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34303
        • Dilek Yıldırım

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • volunteer
  • have not had venipuncture in the last 1 week

Exclusion Criteria:

  • Patients with psychological and communication problems will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure group
The following applications will be made 10 minutes before the patients in the acupressure group. Hands are washed before applying acupressure. Before acupressure is applied, the patient is allowed to sit in a comfortable position on the sofa in the single blood collection room. Before starting the acupressure application, the arm is rubbed from fingertips to the elbow to relax, and press the acupressure points (Large Intestine Meridian 4th Point [LI 4], Large Intestine Meridian 11th Point [LI 11], and Heart Meridian 7th Point [HT 7]). application is carried out. 2 minutes to each acupressure point. pressure (3 to 5 kg of pressure) is applied. Only one acupressure session is given to each patient, and each acupressure session lasts 10 minutes. Venipuncture is applied to all patients by the same nurse in the same room. Venipuncture is performed from the left arm of all patients using a vacuum tube and a needle tip of 0.8 * 38 mm (21G x 1½, green).
Acupressure will be applied to the patients in the acupressure group for 10 min before the venipuncture procedure. Venipuncuture is applied to all patients by the same nurse in the same room. Venipuncture is performed from the left arm of all patients using a vacuum tube and a needle tip of 0.8 * 38 mm (21G x 1½, green).
Other Names:
  • Venipuncture
No Intervention: Control group
Venipuncture is applied to all patients by the same nurse in the same room. Venipuncture is performed from the left arm of all patients using a vacuum tube and a needle tip of 0.8 * 38 mm (21G x 1½, green).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Before Assessment
Time Frame: 15 minutes before venipuncture

Patients in the acupuncture and control groups will be evaluated with the sociodemographic form 15 minutes before venipuncture.

It was prepared by the researchers by investigating the related literature and studies. In the form, there are 5 questions including some socio-demographic characteristics of the individuals (age, gender, marital status, educational background, BMI).

15 minutes before venipuncture
Before Assessment
Time Frame: 15 minutes before venipuncture
Patients in the acupuncture and control groups will be evaluated with the Visual Anolog Scale for pain assessment 15 minutes before venipuncture. The scale is composed of a 10-cm horizontal or vertical line that starts with "No Pain" and ends with "Worst Pain". The use of Visual Anolog Scale should be explained to the patient very well. The patient is asked to mark his/her pain level on an appropriate point on this line. The distance between the beginning point of "no pain" and this point was measured and recorded as "10". Values range between 0 and 10 and the pain levels of the patients are evaluated over 10 points as 0 = no pain, 10 = worst pain.
15 minutes before venipuncture
Before Assessment
Time Frame: 15 minutes before venipuncture

The satisfaction assessment of the patients during the procedure will be made with the Visual Analog Patient Satisfaction Scale form 15 minutes before venipuncture.

Visual analog patient satisfaction scale is combined with the features of the well-known Visual Analog Patient Satisfaction Scale . It is composed of a 10 cm horizontal line without numbers. The expression of "I am very dissatisfied" is on one end of the line and the expression of "I am very satisfied" is on the other end. The patient should determine his/her satisfaction level by synthesizing all components affecting him/herself about the medical care given and find the point on line corresponding to his/her condition.

15 minutes before venipuncture
Before Assessment
Time Frame: 15 minutes before venipuncture
Patients in the acupuncture and control groups will be evaluated with the State Anxiety Inventory to assess anxiety 15 minutes before venipuncture. The State Anxiety Scale consists of 20 questions about emotions, thoughts, and behaviors which are related to anxiety. The choices on this scale range from 1 (no anxiety) to 4 (extreme anxiety). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and azbove (very severe state anxiety).
15 minutes before venipuncture
After Assessment
Time Frame: 5 minutes after venipuncture

The pain assessment of the patients during the procedure will be made with the Visual Analog Scale within 5 minutes after the venipuncture.

The scale is composed of a 10 cm horizontal or vertical line that starts with "No Pain" and ends with "Worst Pain". The use of Visual Anolog Scale should be explained to the patient very well. The patient is asked to mark his/her pain level on an appropriate point on this line. The distance between the beginning point of "no pain" and this point was measured and recorded as "10". Values range between 0 and 10 and the pain levels of the patients are evaluated over 10 points as 0 = no pain, 10 = worst pain.

5 minutes after venipuncture
After Assessment
Time Frame: 5 minutes after venipuncture

The satisfaction assessment of the patients during the procedure will be made with the Visual Analog Patient Satisfaction Scale within 5 minutes after the venipuncture.

Visual Analog Patient Satisfaction scale is combined with the features of the well-known Visual Analog Patient Satisfaction Scale . It is composed of a 10 cm horizontal line without numbers. The expression of "I am very dissatisfied" is on one end of the line and the expression of "I am very satisfied" is on the other end. The patient should determine his/her satisfaction level by synthesizing all components affecting him/herself about the medical care given and find the point on line corresponding to his/her condition.

5 minutes after venipuncture
After Assessment
Time Frame: 5 minutes after venipuncture

Patients in the acupuncture and control groups will be evaluated with the State Anxiety Inventory to assess anxiety within 5 minutes after the venipuncture.

The State Anxiety Scale consists of 20 questions about emotions, thoughts, and behaviors which are related to anxiety. The choices on this scale range from 1 (no anxiety) to 4 (extreme anxiety). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and azbove (very severe state anxiety).

5 minutes after venipuncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dilek Yıldırım

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IZU01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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