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Completed

NCT Number: NCT04516356

The Effects of Korean Hand Acupressure on Postoperative Nausea-Vomiting and Retching After Thyroidectomy

The study was planned as a randomized controlled experimental study to determine the effect of Korean hand acupressure applied after thyroidectomy on postoperative nausea-vomiting and retching. After ethics committee approval and institutional permission, 42 patients who applied to the general surgery clinic for thyroidectomy between February 1, 2021 and June 1, 2022 and met the inclusion criteria were included in the study. In the light of academic studies reported within the scope of the planned study, the sample size was determined with the effect size d = 0.942 (effect size), α = 0.05 ( margin of error), 1-β = 0.90 (Power) and G-power package program. It was decided to recruit 42 people (21 people per group). The block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician other than the researcher. Patients who met the inclusion criteria and agreed to participate in the study were assigned to the experimental and control groups according to the randomization list. Before the operation, the patient was visited and informed about the purpose, content and the intervention to be applied. After obtaining verbal and written consent from the patients who agreed to participate in the study, the "Individual Characteristics Form" was filled. The first part of the "Patient Follow-up Form" was filled in the experimental and control groups on the day of surgery. Korean hand acupressure was applied to the experimental group 30 minutes before the induction of anesthesia. After determining the pressure/treatment points on the patient's hand due to nausea and vomiting, a 3-5 minute massage was performed with the diagnostic stick. The seeds were then fixed at these points with a paper patch. The seeds were not removed for 8 hours. Massage was done for 3-5 minutes by pressing the seeds every 2 hours and making a curling motion at the same time. At the end of the 8th hour, the application was terminated. The application was made by Sevgi Gür, a researcher trained in Korean hand acupressure. In the control group, no application will be made during and after the surgical intervention, and routine treatment and care was applied. Pain, severity of nausea and vomiting, number of nausea-vomiting and retching, name, dose, frequency and duration of antiemetic drugs used were determined by the researcher at the 2nd, 6th, 12th and 24th hours after the patients in the experimental and control groups applied to the clinic. It was recorded in the second part of the "form". At the end of the 24th hour, the Rhodes Nausea, Vomiting and Retching Index score was evaluated by the researcher.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital

Istanbul, Turkey (Türkiye)

About this study

The universe of the research; patients scheduled for thyroidectomy between February 1, 2021 and June 1, 2022, in the general surgery clinic where the study will be conducted, constituted patients who met the inclusion criteria and agreed to participate in the study. The study was planned as a randomized controlled experimental study. The block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician other than the researcher. Patients who met the inclusion criteria and agreed to participate in the study were assigned to the experimental and control groups according to the randomization list. Research data were collected in the general surgery ward of a hospital from February 1, 2021 to June 1, 2022. The independent variable of the research is Korean hand acupressure. The dependent variables of the study were postoperative nausea-vomiting and retching (number and severity), pain severity (Visual Analog Scale-VAS), Rhodes nausea-vomiting and retching index score average. In the study, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature were used as data collection tools.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between the ages of 18-65,
  • According to the American Association of Anesthesiologists (ASA) classification; ASA score I and II,
  • Elective surgery,
  • Individuals with 2 or more risk factors out of 5 risk factors determined in Koivuranta PONV risk factors
  • Patients who agree to participate in the study will be included in the study.

Exclusion criteria

  • Emergency surgery,
  • Using antiemetic, steroid or opioid 24 hours before surgery,
  • Not agreeing to participate in the research
  • Change in consciousness / acute confusion after surgical intervention,
  • Has a mental or psychiatric illness that prevents communication,
  • Patients whose post-operative condition is unstable will not be included in the study.

Treatment and study plan

Korean hand acupressure

Other

According to the working principle of Korean hand acupressure; There are active points and areas in the hands and feet that fit the whole body. The active points on the hands and feet are properly matched to reflect the anatomy of the whole organism. Areas in the body and systems suitable for them are in constant contact. In the patient, the signal wave moves from the damaged point or area and reaches the appropriate point immediately. Thus, changes such as severe pain, skin discoloration, hardening, thickening and thinning in some parts of the skin occur at that point. With the stimulation of the effective point, a treatment wave occurs that heals the sick organ.

Primary outcomes

  1. Postoperative pain severity

    Time frame: Reported pain severity in the first 24 hours after surgery

    Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain

  2. Postoperative nausea and vomiting severity

    Time frame: Reported nausea and vomiting severity in the first 24 hours after surgery

    Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing

  3. The number of postoperative nausea, vomiting and retching

    Time frame: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery

    The number of nausea, vomiting and retching

  4. Use of antiemetics

    Time frame: In the first 24 hours after surgery

    The name, dose, frequency and time of the antiemetic drugs

  5. Rhodes Nausea Vomiting and Retching Index score

    Time frame: At the end of the 24th hour after surgery

    Evaluation of Rhodes Nausea Vomiting and Retching Index score In order to score the scale, responses to items 1, 3, 6 and 7 are calculated in reverse order; For each answer, they are scored as 0: minimum, 4: most discomfort, and the score obtained from 8 items is added. It is expressed as 32 points, the highest possible value.

Secondary outcomes

  1. Postoperative complications

    Time frame: End of surgery to hospital discharge 5-7 days

    Evaluation of postoperative complications

Sponsors and collaborators

Lead sponsor

Sevgi Gür

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2020
Registry last updated
Aug 3, 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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