NCT06636903

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable anxiety

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 1, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

Acupressure, Suturing, Anxiety, Vital Signs, Emergency Department

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    immediately after suturing

Secondary Outcomes (12)

  • Assessment of blood pressure before acupressure

    Just before acupressure

  • Assessment of Blood Pressure After Acupressure

    After acupressure

  • Assesment of blood pressure after suturing

    after suturing

  • Assesment of heart rate before acupressure

    before acupressure

  • Assesment of heart rate after acupressure

    after acupressure

  • +7 more secondary outcomes

Study Arms (2)

Acupressure group

EXPERIMENTAL

Acupressure will be applied to the experimental group before suturing.

Other: Acupressure

control group

NO INTERVENTION

No intervention will be made to the control group. Routine emergency room practice will be carried out.

Interventions

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.

Acupressure group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • 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.),
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersEmergencies

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Ezgi Bolat, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A biostatistician who is not involved in the study will be randomly assigned to groups A and B created by a biostatistician in a computer environment. As a result of the drawing of lots, whether groups A and B will be the study or control group will be determined by tossing a coin at the beginning of the study. Information indicating that the patients included in the study sample were assigned to groups A and B according to the randomization table will be placed in an opaque envelope. This envelope will be kept by the coordinator researcher (GAU) and when the researcher (EB) goes to the patient for the application, he will open the envelope after filling out the \"Informed Consent Form\" and learn which group the patient is in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized parallel controlled experimental study design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 15, 2024

Study Start

October 1, 2024

Primary Completion

November 1, 2024

Study Completion

April 30, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10