- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665518
The Effect of Acupressure on Acute Pain, Stress and Satisfaction During Venipuncture
The Effect of Acupressure on Acute Pain, Stress and Satisfaction During Venipuncture : Single-blind, Randomised Controlled Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34303
- Dilek Yıldırım
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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).
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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:
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Before Assessment
Time Frame: 15 minutes before venipuncture
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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
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Before Assessment
Time Frame: 15 minutes before venipuncture
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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.
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15 minutes before venipuncture
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Before Assessment
Time Frame: 15 minutes before venipuncture
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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
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Before Assessment
Time Frame: 15 minutes before venipuncture
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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).
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15 minutes before venipuncture
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After Assessment
Time Frame: 5 minutes after venipuncture
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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
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After Assessment
Time Frame: 5 minutes after venipuncture
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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
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Dilek Yıldırım
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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