The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting (Acupress)

September 13, 2023 updated by: Tugba CAM YANIK, Mersin University

The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting in ENT Surgery

The study was conducted in the ENT Clinic of Mersin Şehir Training and Research Hospital between June 1 and December 1, 2021, with a total of 60 adult patients, 30 in the study group and 30 in the control group, who met the inclusion and exclusion criteria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the study, 60 patients were randomly assigned to the study and control groups. The study group (n = 30) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the thumb and the LI4 points located in the space between the index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied for an average of 15 minutes. No intervention didn't made to the control group (n = 30). The primary outcome of the study is the effect of acupressure on the state and trait anxiety level of patients. The secondary outcome of the study is the effect of acupressure on pain and nausea and vomiting level in patients. Anxiety levels of the patients were evaluated before and 15 minutes after acupressure application; pain levels were evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first 24 hours after surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Mersin
      • Yeni̇şehi̇r, Mersin, Turkey, 33120
        • Tuğba ÇAM YANIK

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Emergency ENT surgery,
  • Refused to participate in the research,
  • Did not sign the Informed Consent Form,
  • Have a physical problem that prevents the application of acupressure to EX-HN3 (Yintang), LI4 and HT7 points,
  • Diagnosed with anxiety, panic attacks and taking medication for anxiety,
  • Previous surgical experience,
  • Under 18 and over 65,
  • People with vision, hearing and perception problems,
  • unable to read and write Turkish,
  • Have any problem that prevents them from communicating cognitively, emotionally and verbally,
  • Experience in acupressure,
  • Patients who have received sedative medication before surgical intervention didn't be included in the study.

Exclusion Criteria:

  • Emergency ENT surgery,
  • Refused to participate in the research,
  • Did not sign the Informed Consent Form,
  • Diagnosed with anxiety, panic attacks and taking medication for anxiety,
  • Previous surgical experience
  • Under 18 and over 65,
  • People with vision, hearing and perception problems,
  • unable to read and write Turkish,
  • Have any problem that prevents them from communicating cognitively, emotionally and verbally,
  • Experience in acupressure,
  • Patients who have received sedative medication before surgical intervention didn't be included in the study.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group (experimental)
The order of application was determined by lottery. HT7, LI4 and EX-HN3 points were applied respectively. Before starting the application, the area around to be pressurized was gently rubbed with the palm of the hand for 20-30 seconds. The surrounding tissue was relieved by rubbing gently. After rubbing, pressure was applied to the point determined based on the pain threshold level of each individual with a depth of 1-1.5 cm with the thumb for 5 seconds, rested for 2 seconds and the application was continued for 2 minutes. Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points).
Other: Acupressure
Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points). During the application, the most appropriate position in which the individual would be comfortable was preferred, taking into account the privacy of the individual. First of all, the supine position was preferred, and alternatively, the sitting position was preferred. At the end of the application, it was ensured that the person was in a position that he/she was comfortable.
Other Names:
  • Acupress
No Intervention: Standard of care
Standard care was given.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety evaluated using the State Anxiety Scale
Time Frame: Change from before implementation and immediately after, 15th minutes after implementation
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
Change from before implementation and immediately after, 15th minutes after implementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numerical Pain Scale
Time Frame: Change from the 4th hour after surgery, through the discharge, an average of 2 days
In this scale, the patient is asked to describe the severity of his/her pain in numbers, and the scale consists of a horizontal line, with "0" or "no pain" at the starting point and "10" or "unbearable pain" at the end point. The numbers from 0 to 10 are equally spaced on the horizontal line and 1-3 is defined as mild pain, 4-6 as moderate pain and 7-10 as severe pain.
Change from the 4th hour after surgery, through the discharge, an average of 2 days
Nausea and vomiting
Time Frame: Change from surgery to the first 24 hours
The responses for each item are scored between zero (least discomfort) and four (most discomfort). The scores obtained from the eight items are summed to obtain a total score. The maximum score that can be obtained from the index is 32, which is also considered as the most severe symptom occurrence experience score.
Change from surgery to the first 24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gülay Altun Ugras, PhD, Mersin University
  • Principal Investigator: Serpil YÜKSEL, PhD, Necmettin Erbakan University
  • Principal Investigator: Bahar TAŞDELEN, PhD, Mersin University
  • Principal Investigator: Seda TÜRKİLİ, Doctor, Mersin City Hospital
  • Principal Investigator: Serkan TÜRKİLİ, Doctor, Mersin City Hospital
  • Principal Investigator: Ahmet KARAMAN, PhD, Mersin University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mersin University.

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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