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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Korean hand acupressure
Sponsored by
Sevgi Gür
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Nausea and Vomiting focused on measuring Postoperative nausea and vomiting, Nursing, Acupressure, Thyroidectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Korean hand acupressure will be applied to the experimental group 30 minutes before the induction of anesthesia. After determining the pressure / therapy points associated with nausea and vomiting on the patient's hand, a massage will be made for 3-5 minutes with a diagnostic stick. The seeds will then be fixed at these points with a paper patch. Seeds will not be removed for 24 hours. It will be massaged for 3-5 minutes by pressing the seeds every 3-4 hours and making a curling motion at the same time. At the end of the 24th hour, the application will be terminated.

In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.

Outcomes

Primary Outcome Measures

Postoperative pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Postoperative nausea and vomiting severity
Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
The number of postoperative nausea, vomiting and retching
The number of nausea, vomiting and retching
Use of antiemetics
The name, dose, frequency and time of the antiemetic drugs
Rhodes Nausea Vomiting and Retching Index score
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 Outcome Measures

Postoperative complications
Evaluation of postoperative complications

Full Information

First Posted
August 13, 2020
Last Updated
August 1, 2023
Sponsor
Sevgi Gür
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1. Study Identification

Unique Protocol Identification Number
NCT04516356
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sevgi Gür

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative nausea and vomiting, Nursing, Acupressure, Thyroidectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled experimental study to determine the effect of Korean hand acupressure applied after thyroidectomy on postoperative nausea-vomiting and retching.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Korean hand acupressure will be applied to the experimental group 30 minutes before the induction of anesthesia. After determining the pressure / therapy points associated with nausea and vomiting on the patient's hand, a massage will be made for 3-5 minutes with a diagnostic stick. The seeds will then be fixed at these points with a paper patch. Seeds will not be removed for 24 hours. It will be massaged for 3-5 minutes by pressing the seeds every 3-4 hours and making a curling motion at the same time. At the end of the 24th hour, the application will be terminated.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.
Intervention Type
Other
Intervention Name(s)
Korean hand acupressure
Intervention Description
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 Outcome Measure Information:
Title
Postoperative pain severity
Description
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Time Frame
Reported pain severity in the first 24 hours after surgery
Title
Postoperative nausea and vomiting severity
Description
Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing
Time Frame
Reported nausea and vomiting severity in the first 24 hours after surgery
Title
The number of postoperative nausea, vomiting and retching
Description
The number of nausea, vomiting and retching
Time Frame
Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
Title
Use of antiemetics
Description
The name, dose, frequency and time of the antiemetic drugs
Time Frame
In the first 24 hours after surgery
Title
Rhodes Nausea Vomiting and Retching Index score
Description
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.
Time Frame
At the end of the 24th hour after surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Evaluation of postoperative complications
Time Frame
End of surgery to hospital discharge 5-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlhan Öztekin, Prof
Organizational Affiliation
Yeditepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deniz S. Öztekin, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sevgi Gür, MSC
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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