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

NCT ID: NCT06040411

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety State Pain Vomiting Nausea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The statistician was blinded to analyze the data.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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.

Standard of care

Standard care was given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Acupress

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mersin University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tugba CAM YANIK

Principal Investigator Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gülay ALTUN UĞRAŞ, PhD

Role: STUDY_DIRECTOR

Mersin University

Serpil YÜKSEL, PhD

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Bahar TAŞDELEN, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Seda TÜRKİLİ, Doctor

Role: PRINCIPAL_INVESTIGATOR

Mersin City Hospital

Serkan TÜRKİLİ, Doctor

Role: PRINCIPAL_INVESTIGATOR

Mersin City Hospital

Ahmet KARAMAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tuğba ÇAM YANIK

Yenişehir, Mersin, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mersin University.

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.