Pain, AcuteNCT04665518
The Effect of Acupressure on Acute Pain, Stress and Satisfaction During Venipuncture
A study testing Acupressure in people with Pain, Acute and Satisfaction, Patient, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Satisfaction, Patient, Stress
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteer
- have not had venipuncture in the last 1 week
Who cannot join
- Patients with psychological and communication problems will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Acute, Satisfaction, Patient, Stress
- Being tested
- Acupressure
- Keywords
- Acupressure, acute pain, stress, satisfaction, nursing, nonpharmacological methods
- Medical subject headings
- Acute Pain, Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Also called Venipuncture
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).
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | 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). Receives: Other: Acupressure |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Before Assessment
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).
Measured: 15 minutes before venipuncture
Before Assessment
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.
Measured: 15 minutes before venipuncture
Before Assessment
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.
Measured: 15 minutes before venipuncture
Before Assessment
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).
Measured: 15 minutes before venipuncture
After Assessment
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.
Measured: 5 minutes after venipuncture
After Assessment
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.
Measured: 5 minutes after venipuncture
After Assessment
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).
Measured: 5 minutes after venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start15 Nov 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Sabahattin Zaim University
- Investigators
- Dilek Yıldırım, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665518
- Sponsor's protocol ID
- IZU01
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koc Ozkan T, Balci S. The Effect of Acupressure on Acute Pain During Venipuncture in Children: Implications for Evidence-Based Practice. Worldviews Evid Based Nurs. 2020 Jun;17(3):221-228. doi: 10.1111/wvn.12437. Epub 2020 Apr 22.
PubMed 32320139
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Acute Pain, Stress and Satisfaction During Venipuncture : Single-blind, Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04665518
- Acronym / sponsor ID
- IZU01
- Conditions
- Pain, Acute, Satisfaction, Patient, Stress
- Keywords
- Acupressure, acute pain, stress, satisfaction, nursing, nonpharmacological methods
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureThe 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). |
| Control group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- volunteer
- have not had venipuncture in the last 1 week
Key exclusion criteria (1 listed)
- Patients with psychological and communication problems will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureAlso: VenipunctureAcupressure 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 | Acupressure group |
Primary outcome
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).
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.
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.
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).
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.
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Results publication: PubMed 32320139Koc Ozkan T, Balci S. The Effect of Acupressure on Acute Pain During Venipuncture in Children: Implications for Evidence-Based Practice. Worldviews Evid Based Nurs. 2020 Jun;17(3):221-228. doi: 10.1111/wvn.12437. Epub 2020 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Yıldırım principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Pain, Acute and Satisfaction, Patient, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Before Assessment (time frame: 15 minutes before venipuncture). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.