- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06040411
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- 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
-
-
Mersin
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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
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 |
Intervention / Treatment |
---|---|
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).
|
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:
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No Intervention: Standard of care
Standard care was given.
|
What is the study measuring?
Primary Outcome Measures
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
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.
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Change from the 4th hour after surgery, through the discharge, an average of 2 days
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Nausea and vomiting
Time Frame: Change from surgery to the first 24 hours
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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.
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Change from surgery to the first 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gülay Altun Ugras, PhD, Mersin University
- Principal Investigator: SERPİL 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)
June 1, 2021
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
August 22, 2023
First Submitted That Met QC Criteria
September 13, 2023
First Posted (Actual)
September 15, 2023
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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