Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT2016081229311N1 |
Date of registration:
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2016-08-24 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Effect of Neiguan Point (p6) Acupressure with Wristband on Postoperative Nausea, Vomiting, and Comfort Level: A Randomized Controlled Study
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Scientific title:
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The Effect of Neiguan Point (p6) Acupressure with Wristband on Postoperative Nausea, Vomiting, and Comfort Level: A Randomized Controlled Study |
Date of first enrolment:
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2013-02-02 |
Target sample size:
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97 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/23595 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Objective and design of the study The study was designed as a randomized-controlled experimental study to determine the effect of wrist P6 acupuncture point acupressure application with wristband on nausea, vomiting, and comfort level at the postoperative period. The following hypotheses were tested: H1A: Wrist P6 (Neiguan) acupuncture point acupressure application with wristband is effective as pharmacological methods in prevention of postoperative nausea. H1B: Wrist P6 acupuncture point acupressure application with wristband is effective as pharmacological methods in prevention of postoperative vomiting. H1C: Wrist P6 acupuncture point acupressure application with wristband enhances patient comfort.
Study variables: Wrist P6 acupuncture point acupressure application with wristband is the independent variable of the study.
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Nurten Kaya
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Address:
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Demirkapi Cad. Karabal Sk. Bakirköy Ruh ve Sinir Hastaliklari Hastanesi Bahçesi Içi
34740
Istanbul
Turkey |
Telephone:
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00902124141500 |
Email:
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nurka@istanbul.edu.tr, nurtenkaya66@gmail.com, nurtenkaya66@hotmail.com |
Affiliation:
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Istanbul University |
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Name:
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Nurten Kaya
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Address:
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Demirkapi Cad. Karabal Sk. Bakirköy Ruh ve Sinir Hastaliklari Hastanesi Bahçesi Içi
34740
Istanbul
Turkey |
Telephone:
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00902124141500 |
Email:
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nurka@istanbul.edu.tr, nurtenkaya66@gmail.com, nurtenkaya66@hotmail.com |
Affiliation:
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Istanbul University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age between 18-65 years, Patient underwent gynecological operation; Operation was performed under general anesthesia; The patient had no cognitive; sensory or verbal communication issues; Patient volunteered to participate in the study.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
64 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Surgical follow-up care, unspecified
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Postoperative nausea and vomiting. Surgical follow-up care, unspecified
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Intervention(s)
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By screening the list of patients to be operated, those patients who met study inclusion criteria were determined. Those who were selected for enrollment in the study were informed about nausea occurring at the postoperative period, and about acupressure or antiemetic application that were used to prevent it. They were given written and verbal information about the study procedure. Individuals volunteering to participate in the study signed the Informed Voluntary Consent Form. Enrolled patients were randomly divided into patient and control groups by drawing lots. Consequently, the Patient Information Form and State-Trait Anxiety Inventory were filled; and groups were evaluated for presence of any difference.
At postoperative period; Experimental Group: Within the first 12 hours after the operation, acupressure with wristband was applied to patient group. Anesthesiologists were informed of these patients group to make sure that they were not administered anti emetics intra-operatively
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Treatment - Devices
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By screening the list of patients to be operated, those patients who met study inclusion criteria were determined. Those who were selected for enrollment in the study were informed about nausea occurring at the postoperative period, and about acupressure or antiemetic application that were used to prevent it. They were given written and verbal information about the study procedure. Individuals volunteering to participate in the study signed the Informed Voluntary Consent Form. Enrolled patients were randomly divided into patient and control groups by drawing lots. Consequently, the Patient Information Form and State-Trait Anxiety Inventory were filled; and groups were evaluated for presence of any difference. At postoperative period; Experimental Group: Within the first 12 hours after the operation, acupressure with wristband was applied to patient group. Anesthesiologists were informed of these patients group to make sure that they were not administered anti emetics intra-operatively. Intensity of nausea and presence of vomiting at the postoperative period were documented on the Nausea and Vomiting Follow-up Form. In case intensity of nausea did not decrease or vomiting persisted, then patient’s physician was informed, and anti-emetics ordered by the physician were administered to the patient. In such a case, the patient was excluded from the experimental group. Two patients were excluded from the experimental group due to these reasons. Thus, any harm to the patient was prevented, and all arrangements required for patients to have optimum benefit from care-treatment interventions were provided. Control Group: The protocol in the hospital where the study was conducted is that all patients undergoing surgery (including A, B, and C group) are administered anti-emetics intraoperatively. Therefore, all patients in the control group received intra-operative anti-emetics. Additionally, patients in the control group received anti-emetics within the first 12 hours a
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Primary Outcome(s)
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Nausea, vomiting, and comfort level at the postoperative period. Timepoint: Postoperative period. Method of measurement: This was a single-center, randomized-controlled experimental study conducted in the Turkey.
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Secondary Outcome(s)
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Nausea, vomiting, and comfort level at the postoperative period. Timepoint: Postoperative period. Method of measurement: This was a single-center, randomized-controlled experimental study conducted in the Turkey.
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Source(s) of Monetary Support
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Tek Grup
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Ethics review
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Status: Approved
Approval date:
Contact:
Uludag University Faculty of Medicine Clinical Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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