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The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy

Primary Purpose

Laparoscopic Cholecystectomy, Postoperative Nausea, Postoperative Vomiting

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold vapor
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopic Cholecystectomy focused on measuring Nausea, Vomiting, Nursing care

Eligibility Criteria

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

Inclusion Criteria:

  • Being 18 years or older
  • To undergo laparoscopic cholecystectomy
  • Having an ASA score of 1-2
  • Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room.
  • Having a Modified Aldrete score of at least 9 in the postoperative recovery room
  • To be willing to participate in the study.

Exclusion Criteria:

  • To undergo emergency surgery
  • Being under the age of 18
  • Having an ASA score of 3 and above
  • Not agreeing to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cold vapor group

    Control group

    Arm Description

    Cold vapor will be applied to the experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtime-un600aultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.

    Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of nausea and vomiting when they come to the recovery room and at the 2nd, 6th,12th, and 24th hours after the surgery in the postoperative service.

    Outcomes

    Primary Outcome Measures

    Cold vapor
    The Visual Analogue Scale (VAS) of the patients for nausea who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.
    Cold vapor
    The Postoperative Nausea and Vomiting Impact Scale of the patients for nausea and vomiting who underwent cold vapor are decreased compared to those who do not. A score between 0 and 6 is taken from the Postoperative Nausea and Vomiting Impact Scale. It is good that the score from the Postoperative Nausea and Vomiting Impact Scale has decreased.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2022
    Last Updated
    April 1, 2022
    Sponsor
    Istanbul Medeniyet University
    Collaborators
    Atlas University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05302128
    Brief Title
    The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy
    Official Title
    The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 11, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    November 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medeniyet University
    Collaborators
    Atlas University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV is divided into three as early, late, and delayed. Nausea-vomiting developing within 2-6 hours after surgery is classified as early, nausea-vomiting developing within 6-24 hours after surgery is classified as delayed, and nausea and/or vomiting developing within the first 24 hours after surgery are classified as delayed PONV. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important.
    Detailed Description
    Postoperative nausea and vomiting (PONV) was defined by the American Society of PeriAnesthesia Nurses (ASPAN) as nausea and/or vomiting in the first 24 hours after surgery and is among the most common complications after pain in patients undergoing surgery. PONV increases the length of stay in the recovery room, delays starting oral intake, causes fluid and electrolyte imbalance, and causes pain, dehydration, delayed wound healing, decreased patient comfort, prolonged hospitalization, and increased cost. Therefore, the prevention and management of nausea and vomiting in the perioperative period in surgical patients are very important. In a meta-analysis study that included data from eleven countries, the prevalence of PONV was 27.7%, the prevalence of postoperative nausea was 31.4% and the prevalence of post-operative vomiting was 16.8%. In a study conducted in Turkey, it was reported that 45.9% of surgical patients had nausea and 23.6% had vomiting in the postoperative period. In another study conducted in the postoperative recovery unit, it was reported that 29% of the patients experienced nausea and vomiting. The risk of PONV may vary depending on the patient, anesthesia, and surgical intervention. Patient-related risk factors include female gender, young age (under 50 years of age), obesity, history of motion sickness; anesthesia-related risk factors include the type of anesthesia, duration of administration, use of volatile anesthetics, opioids, and nitrous oxide; Among the risk factors for previous surgical interventions are laparoscopic, bariatric, gynecological and cholecystectomy surgeries. Pharmacological treatment, non-pharmacological treatment methods, or both are used in the management of PONV in patients undergoing surgical intervention. Today, a multimodal approach is recommended in the management of PONV in early recovery protocols in surgical patients. Antiemetic drugs used among pharmacological methods can cause side effects such as headache, constipation, drowsiness, tremor, irregular heartbeat, and wound infection. Therefore, non-pharmacological treatment methods have an important place in care practices. In the literature, there are many studies on the successful application of non-pharmacological treatment methods such as massage, progressive relaxation exercises, hypnosis, acupuncture, yoga, acupressure, transcutaneous electrical nerve stimulation, music therapy, herbal treatments, and aromatherapy in the prevention of PONV. The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. Temperature can affect the release of odorous volatile substances in drugs. The cold application also has clinically important potential effects on nausea caused by unpleasant tastes by reducing the olfactory component of negative aromas. Cold can be applied in different ways. One of them is administration by inhalation. In the literature, there are studies on the positive effects of cold vapor application on sore throat, cough, swallowing, and hoarseness. In a study, it was determined that postoperative nausea and vomiting were less in patients who received oral care with the cold application after laparoscopic myomectomy compared to the control group. There is no study in the literature examining the effect of cold vapor application on PONV.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Cholecystectomy, Postoperative Nausea, Postoperative Vomiting
    Keywords
    Nausea, Vomiting, Nursing care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who were hospitalized for laparoscopic cholecystectomy and met the sample selection criteria will be included in the experimental and control groups by block randomization method using the random numbers table on the computer.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cold vapor group
    Arm Type
    Experimental
    Arm Description
    Cold vapor will be applied to the experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtime-un600aultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of nausea and vomiting when they come to the recovery room and at the 2nd, 6th,12th, and 24th hours after the surgery in the postoperative service.
    Intervention Type
    Other
    Intervention Name(s)
    Cold vapor
    Intervention Description
    Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of nausea and vomiting before and 15 minutes after the cold vapor application in the recovery room and at the 2nd, 6th,12th, and 24th hours after the cold vapor application in the postoperative service.
    Primary Outcome Measure Information:
    Title
    Cold vapor
    Description
    The Visual Analogue Scale (VAS) of the patients for nausea who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.
    Time Frame
    First 24 hours after surgery
    Title
    Cold vapor
    Description
    The Postoperative Nausea and Vomiting Impact Scale of the patients for nausea and vomiting who underwent cold vapor are decreased compared to those who do not. A score between 0 and 6 is taken from the Postoperative Nausea and Vomiting Impact Scale. It is good that the score from the Postoperative Nausea and Vomiting Impact Scale has decreased.
    Time Frame
    First 24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being 18 years or older To undergo laparoscopic cholecystectomy Having an ASA score of 1-2 Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room. Having a Modified Aldrete score of at least 9 in the postoperative recovery room To be willing to participate in the study. Exclusion Criteria: To undergo emergency surgery Being under the age of 18 Having an ASA score of 3 and above Not agreeing to participate in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özlem İbrahimoğlu, PhD
    Phone
    +905436195971
    Email
    oogutlu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Betül Güven, PhD
    Phone
    +905325283751
    Email
    betulguwen@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    A decision will be made after consultation with other researchers.
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    The Effect of Cold Vapor on Nausea and Vomiting in the Early Postoperative Period After Laparoscopic Cholecystectomy

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