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Completed

NCT Number: NCT06040411

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

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.

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Key information

Conditions

Anxiety State Anxiety Disorders Mental Disorders Nausea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba ÇAM YANIK

Yenişehir, Mersin, 33120, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupressure

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.

Other names: Acupress

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Acronym: Acupress

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 15, 2023
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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