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Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort

Primary Purpose

Inhalation; Oil

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peppermint Oil Inhalation
Sponsored by
Gümüşhane Universıty
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inhalation; Oil focused on measuring patient, nausea, Vomiting, mentha piperita, postoperative

Eligibility Criteria

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

Inclusion Criteria:

  • over 18 years old, 65 years old and under,
  • having colonoscopy,
  • not having the risk of heart failure and cardiogenic shock (class III and IV),
  • not having a history of asthma, eczema and allergies to flowers and plants,
  • no peppermint oil allergy,
  • no communicative / severe hearing or speech impairment,
  • no use of antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives
  • ASA score of 1 or 2
  • Individuals willing to participate will be included in the study.

Exclusion Criteria:

• Individuals who do not meet the inclusion criteria will not be included in the

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control

    Arm Description

    Peppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation.

    Patients who underwent surgery will be monitored for the severity of nausea and vomiting after surgery. Follow-ups are 0-2, 2-6, 6-12, 12-24 and 24-48 postoperatively. hours and will be recorded without any application or intervention by the researcher.

    Outcomes

    Primary Outcome Measures

    Nause
    post-operative nausea rate

    Secondary Outcome Measures

    Full Information

    First Posted
    October 15, 2022
    Last Updated
    October 26, 2022
    Sponsor
    Gümüşhane Universıty
    Collaborators
    Kırklareli University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05585086
    Brief Title
    Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
    Official Title
    Determination of the Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2022 (Anticipated)
    Primary Completion Date
    March 20, 2023 (Anticipated)
    Study Completion Date
    April 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gümüşhane Universıty
    Collaborators
    Kırklareli University

    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
    Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. In this study it was aimed to evaluate the effect of peppermint oil inhalation on postoperative nausea and vomitting. Purpose and Type of Research The randomized controlled study will be performed on patients undergoing laparoscopic cholecystectomy, which is the most commonly performed surgical procedure, in a general surgery clinic of a training and research hospital.
    Detailed Description
    Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. In this study it was aimed to evaluate the effect of peppermint oil inhalation on postoperative nausea and vomitting. Purpose and Type of Research The randomized controlled study will be performed on patients undergoing laparoscopic cholecystectomy, which is the most commonly performed surgical procedure, in a general surgery clinic of a training and research hospital. Location of the research This research will be carried out in a 24-bed general surgery clinic of a 250-bed training and research hospital located in western Turkey. In the Surgery Service, nurses work in three shifts, 08:00-16:00, 16:00-24:00 and 24:00-08:00, while the responsible nurse works between 08:00-17:00. In the surgical service, there are a total of 24 patient rooms, all of which are single beds. Clinical routines in the surgery clinic include pharmacological methods and there is no use of complementary therapy methods. Population and Sample of the Research 60 patients are planned to be included in the study. In the creation of randomization; Experiment and control group will be assigned by computer method. In this way, experimental applications will be continued until the number of patients in both groups is completed. During the trial period, patients who wish to withdraw or need to be excluded from the trial will be excluded. Research Hypotheses H0. Peppermint oil inhalation has no effect on post-operative nausea. H1. Peppermint oil inhalation has an effect on post-operative nausea. H0. Peppermint oil inhalation has no effect on postoperative comfort. H0. Peppermint oil inhalation has an effect on postoperative comfort.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inhalation; Oil
    Keywords
    patient, nausea, Vomiting, mentha piperita, postoperative

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Peppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients who underwent surgery will be monitored for the severity of nausea and vomiting after surgery. Follow-ups are 0-2, 2-6, 6-12, 12-24 and 24-48 postoperatively. hours and will be recorded without any application or intervention by the researcher.
    Intervention Type
    Other
    Intervention Name(s)
    Peppermint Oil Inhalation
    Intervention Description
    Peppermint oil will be given by diluting 1/10 in wheat oil so that it does not cause skin irritation. Application; by inhalation method, 2 cc lavender essential oil + 100 cc water (2%) will be in the form of two drops for 20 minutes. Since the effectiveness of essential oils decreases over time and the desired dose cannot be applied at the same time; Peppermint oil will be applied to the individual for a total of 5 times every 30 minutes.
    Primary Outcome Measure Information:
    Title
    Nause
    Description
    post-operative nausea rate
    Time Frame
    7 day

    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: over 18 years old, 65 years old and under, having colonoscopy, not having the risk of heart failure and cardiogenic shock (class III and IV), not having a history of asthma, eczema and allergies to flowers and plants, no peppermint oil allergy, no communicative / severe hearing or speech impairment, no use of antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives ASA score of 1 or 2 Individuals willing to participate will be included in the study. Exclusion Criteria: • Individuals who do not meet the inclusion criteria will not be included in the

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort

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