Clinical trial NCT04516356: The Effects of Korean Hand Acupressure on Postoperative Nausea-Vomiting and Retching After Thyroidectomy
Official title: The Effects of Korean Hand Acupressure on Postoperative Nausea-Vomiting and Retching After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative nausea and vomiting
Nursing
Acupressure
Thyroidectomy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled experimental study to determine the effect of Korean hand acupressure applied after thyroidectomy on postoperative nausea-vomiting and retching.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain severity
timeFrame: Reported pain severity in the first 24 hours after surgery
measure: Postoperative nausea and vomiting severity
timeFrame: Reported nausea and vomiting severity in the first 24 hours after surgery
measure: The number of postoperative nausea, vomiting and retching
timeFrame: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
measure: Use of antiemetics
timeFrame: In the first 24 hours after surgery
measure: Rhodes Nausea Vomiting and Retching Index score
timeFrame: At the end of the 24th hour after surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: End of surgery to hospital discharge 5-7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital
Study officials:
affiliation: Yeditepe University
name: İlhan Öztekin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Deniz S. Öztekin, Prof
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Sevgi Gür, MSC
role: STUDY_CHAIR
References: