AnxietyNCT06636903
The Effect of Acupressure Applied Before Suturing Procedure in the Emergency Department on Anxiety and Vital Signs
A study testing Acupressure in people with Anxiety and Vital Signs, run by Ezgi BOLAT.
Trial summary
This study suggests that the anxiety experienced by patients during suturing in the emergency department can be reduced with acupressure and offers a research proposal on vital signs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Vital Signs
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Apr 2025
- 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
- Suturing is done with local anesthesia,
- Those who are 18 years or older,
- Conscious, oriented and cooperative,
- Able to read and understand Turkish,
- Agreeing to participate in the study,
- Anxiety not diagnosed,
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- Not using medication for anxiety,
- No acupressure experience,
- No physical problems that would prevent acupressure application to Ht7 and Li4 points,
- Not pregnant,
- Patients who sign the \"Voluntary Informed Consent Form\" will be included.
Who cannot join
- Those who are under 18 years of age,
- Unconscious, unoriented and uncooperative,
- Cannot read and understand Turkish,
- Those who do not agree to participate in the study,
- -Diagnosed with anxiety,
- -Using medication for anxiety (anxiolytic, antidepressant, antipsychotic, etc.),
Show all 10Show fewer
- Having previous acupressure experience,
- Having a physical problem that prevents the application of acupressure to Ht7 and Li4 points,
- Pregnant,
- Patients who do not sign the \"Voluntary Informed Consent Form\" will not be included.
Trial locations and contacts
No sites are listed yet.
About this study
This study suggests that the anxiety experienced by patients during suturing in the emergency department can be reduced with acupressure and offers a research proposal on vital signs.
Problem: During suturing in the emergency department, patients experience high levels of anxiety due to the pain they experience and fear of the procedure. This situation complicates the treatment process, negatively affects the health of patients and creates a difficult situation for healthcare professionals.
Read more
Solution Suggestion: Acupressure can be used as a non-invasive, safe and effective method to reduce patients\' anxiety. Acupressure reduces pain, provides relaxation and reduces anxiety by increasing the secretion of endorphins in the body.
Purpose of the Study: The purpose of this study is to evaluate the effects of applying acupressure to patients before suturing in the emergency department on their anxiety levels and vital signs (such as blood pressure, heart rate).
In summary, this research has a significant potential that emergency room nurses can improve patients\' quality of life and make treatment processes more effective by using acupressure in patient care.
Key Words: Acupressure, Suturing, Anxiety, Vital Signs, Emergency Department
- Conditions
- Anxiety, Vital Signs
- Being tested
- Acupressure
- Keywords
- Acupressure, Suturing, Anxiety, Vital Signs, Emergency Department
- Medical subject headings
- Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Before pressing directly on the point for acupressure, a gentle warming, relaxing and preparatory process of approximately 15 seconds should be performed on the point area. In this case, manual pressure with the thumb, index finger and/or middle finger will be applied sequentially (in the rhythm of breathing) without lifting the finger for an average of 1.5 minutes on each point, at a frequency that does not disturb the person, does not cause pain and has a calming effect. Before the suturing procedure, acupressure will be applied to the HT7 and Li4 points by a researcher (EB) who has an acupressure certificate.
AcupressureOther
Also called Acupressure Group
Before and after acupressure, vital signs and before acupressure, anxiety scores will be checked using the Spielger State Anxiety Scale. In addition, vital signs and anxiety scores will be checked again immediately after the stitching procedure.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | Acupressure will be applied to the experimental group before suturing. Receives: Other: Acupressure |
| control group | No intervention | No intervention will be made to the control group. Routine emergency room practice will be carried out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anxiety before acupressure
Before the suturing procedure, acupressure will be applied to the Ht7 and Li4 points.The state anxiety scale consists of 20 questions. The statements in the SAS are evaluated as none 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. Reversed statements are: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The SAS score is calculated by adding the constant value of 50 to the value obtained by subtracting the total score of the reversed statements from the total score of the direct statements. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A total score of 0-19 from the SAS indicates no anxiety, a score of 20-39 indicates mild anxiety, a score of 40-59 indicates moderate anxiety and a score of 60-79 indicates a severe anxiety level. It is stated that individuals who score above 60 on the SAS need professional help.
Measured: before suturing
Evaluation of anxiety after suturing
Immediately after the stitching, the anxiety scale will be filled out again. The statements in the SAS are evaluated as none 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. Reversed statements are: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The SAS score is calculated by adding the constant value of 50 to the value obtained by subtracting the total score of the reversed statements from the total score of the direct statements. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A total score of 0-19 from the SAS indicates no anxiety, a score of 20-39 indicates mild anxiety, a score of 40-59 indicates moderate anxiety and a score of 60-79 indicates a severe anxiety level. It is stated that individuals who score above 60 on the DAS need professional help.
Measured: immediately after suturing
Secondary outcomes (12)
Assessment of blood pressure before acupressure
Vital signs will be monitored immediately before acupressure. The patient's blood pressure will be monitored before acupressure. The patients' blood pressure will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). Systolic blood pressure of 100-130 mmHg, diastolic blood pressure of 60-80 mmHg. Normal blood pressure is usually considered to be between 90/60 mmHg and 120/80 mmHg.
Measured: Just before acupressure
Assessment of Blood Pressure After Acupressure
Vital signs will be monitored immediately after acupressure. The patient's blood pressure will be monitored after acupressure. The patients' blood pressure will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). Systolic blood pressure of 100-130 mmHg, diastolic blood pressure of 60-80 mmHg. Normal blood pressure is usually considered to be between 90/60 mmHg and 120/80 mmHg.
Measured: After acupressure
Assesment of blood pressure after suturing
Vital signs will be monitored immediately after suturing. The patient's blood pressure will be monitored after suturing. The patients' blood pressure will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). Systolic blood pressure of 100-130 mmHg, diastolic blood pressure of 60-80 mmHg. Normal blood pressure is usually considered to be between 90/60 mmHg and 120/80 mmHg.
Measured: after suturing
Assesment of heart rate before acupressure
Vital signs will be monitored immediately before acupressure. The patient's heart rate will be monitored before acupressure. The patient's heart rate will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). A normal heart rate for adults ranges from 60 to 100 beats per minute.
Measured: before acupressure
Assesment of heart rate after acupressure
Vital signs will be monitored immediately after acupressure. The patient's heart rate will be monitored after acupressure. The patient's heart rate will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). A normal heart rate for adults ranges from 60 to 100 beats per minute.
Measured: after acupressure
Assesment of heart rate after suturing
Vital signs will be monitored immediately after suturing. The patient's heart rate will be monitored after suturing. The patient's heart rate will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). A normal heart rate for adults ranges from 60 to 100 beats per minute.
Measured: after suturing
Assesment of oxygen saturation before acupressure
Vital signs will be monitored immediately before acupressure. The patient's heart rate will be monitored before acupressure. The patient's heart rate will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). For most people, a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%.
Measured: before acupressure
Assesment of oxygen saturation after acupressure
Vital signs will be monitored immediately after acupressure. The patient's heart rate will be monitored after acupressure. The patient's heart rate will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). For most people, a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%.
Measured: after acupressure
Assesment of oxygen saturation after suturing
vVital signs will be monitored immediately after suturing. The patient's heart rate will be monitored after suturing. The patient's heart rate will be monitored on a portable monitor (iMEC 10, Mindray, Chinese). For most people, a normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%.
Measured: after suturing
Assesment of respiratory rate before acupressure
Immediately before acupressure, the respiratory rate will be assessed. The respiratory rate will be counted by observing the chest cage movements for one minute by the researcher (EB). Vital signs are expected to remain within normal values. Normal respiration rates for an adult person range from 16 to 20 breaths per minute.
Measured: before acupressure
Assesment of respiratory rate after acupressure
Immediately after acupressure, After suturing, the respiratory rate will be assessed. The respiratory rate will be counted by observing the chest cage movements for one minute by the researcher (EB). Vital signs are expected to remain within normal values. Normal respiration rates for an adult person range from 16 to 20 breaths per minute.
Measured: after acupressure
Assesment of respiratory rate after suturing
After suturing, the respiratory rate will be assessed. The respiratory rate will be counted by observing the chest cage movements for one minute by the researcher (EB). Vital signs are expected to remain within normal values. Normal respiration rates for an adult person range from 16 to 20 breaths per minute.
Measured: after suturing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Randomized parallel controlled experimental study design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ezgi BOLAT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ezgi BOLAT, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636903
- Sponsor's protocol ID
- MU-EBOLAT-804
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Applied Before Suturing Procedure in the Emergency Department on Anxiety and Vital Signs
- ClinicalTrials.gov ID
- NCT06636903
- Acronym / sponsor ID
- MU-EBOLAT-804
- Conditions
- Anxiety, Vital Signs
- Keywords
- Acupressure, Suturing, Anxiety, Vital Signs, Emergency Department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Ezgi BOLATUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
This study suggests that the anxiety experienced by patients during suturing in the emergency department can be reduced with acupressure and offers a research proposal on vital signs.
Problem: During suturing in the emergency department, patients experience high levels of anxiety due to the pain they experience and fear of the procedure. This situation complicates the treatment process, negatively affects the health of patients and creates a difficult situation for healthcare professionals.
Solution Suggestion: Acupressure can be used as a non-invasive, safe and effective method to reduce patients\' anxiety. Acupressure reduces pain, provides relaxation and reduces anxiety by increasing the secretion of endorphins in the body.
Purpose of the Study: The purpose of this study is to evaluate the effects of applying acupressure to patients before suturing in the emergency department on their anxiety levels and vital signs (such as blood pressure, heart rate).
In summary, this research has a significant potential that emergency room nurses can improve patients\' quality of life and make treatment processes more effective by using acupressure in patient care.
Key Words: Acupressure, Suturing, Anxiety, Vital Signs, Emergency Department
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized parallel controlled experimental study design
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureAcupressure will be applied to the experimental group before suturing. |
| control group | No intervention | –No intervention will be made to the control group. Routine emergency room practice will be carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Suturing is done with local anesthesia,
- Those who are 18 years or older,
- Conscious, oriented and cooperative,
- Able to read and understand Turkish,
- Agreeing to participate in the study,
Key exclusion criteria (10 listed)
- Those who are under 18 years of age,
- Unconscious, unoriented and uncooperative,
- Cannot read and understand Turkish,
- Those who do not agree to participate in the study,
- -Diagnosed with anxiety,
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 |
|---|---|---|
| AcupressureBefore pressing directly on the point for acupressure, a gentle warming, relaxing and preparatory process of approximately 15 seconds should be performed on the point area. In this case, manual pressure with the thumb, index finger and/or middle finger will be applied sequentially (in the rhythm of breathing) without lifting the finger for an average of 1.5 minutes on each point, at a frequency that does not disturb the person, does not cause pain and has a calming effect. Before the suturing procedure, acupressure will be applied to the HT7 and Li4 points by a researcher (EB) who has an acupressure certificate. | Other | Acupressure group |
| AcupressureAlso: Acupressure GroupBefore and after acupressure, vital signs and before acupressure, anxiety scores will be checked using the Spielger State Anxiety Scale. In addition, vital signs and anxiety scores will be checked again immediately after the stitching procedure. | Other | Acupressure group |
Primary outcome
Evaluation of anxiety before acupressure
Time frame: before suturing
Before the suturing procedure, acupressure will be applied to the Ht7 and Li4 points.The state anxiety scale consists of 20 questions. The statements in the SAS are evaluated as none 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. Reversed statements are: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The SAS score is calculated by adding the constant value of 50 to the value obtained by subtracting the total score of the reversed statements from the total score of the direct statements. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A total score of 0-19 from the SAS indicates no anxiety, a score of 20-39 indicates mild anxiety, a score of 40-59 indicates moderate anxiety and a score of 60-79 indicates a severe anxiety level. It is stated that individuals who score above 60 on the SAS need professional help.
Evaluation of anxiety after suturing
Time frame: immediately after suturing
Immediately after the stitching, the anxiety scale will be filled out again. The statements in the SAS are evaluated as none 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. Reversed statements are: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The SAS score is calculated by adding the constant value of 50 to the value obtained by subtracting the total score of the reversed statements from the total score of the direct statements. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A total score of 0-19 from the SAS indicates no anxiety, a score of 20-39 indicates mild anxiety, a score of 40-59 indicates moderate anxiety and a score of 60-79 indicates a severe anxiety level. It is stated that individuals who score above 60 on the DAS need professional help.
12 secondary outcomes
Assessment of blood pressure before acupressure
Time frame: Just before acupressure
Assessment of Blood Pressure After Acupressure
Time frame: After acupressure
Assesment of blood pressure after suturing
Time frame: after suturing
Assesment of heart rate before acupressure
Time frame: before acupressure
Assesment of heart rate after acupressure
Time frame: after acupressure
Assesment of heart rate after suturing
Time frame: after suturing
Assesment of oxygen saturation before acupressure
Time frame: before acupressure
Assesment of oxygen saturation after acupressure
Time frame: after acupressure
Assesment of oxygen saturation after suturing
Time frame: after suturing
Assesment of respiratory rate before acupressure
Time frame: before acupressure
Assesment of respiratory rate after acupressure
Time frame: after acupressure
Assesment of respiratory rate after suturing
Time frame: after suturing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Anxiety and Vital Signs, run by Ezgi BOLAT.
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 11 inclusion and 10 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ezgi Bolat, Master (+90-538-055-8567, ezgibolat35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of anxiety before acupressure (time frame: before suturing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.