- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273162
The Effect of Cold Vapor on Dyspnea, Thirst, Nausea, and Physiological Parameters in the PACU After Laparoscopic Inguinal Hernia Surgery
The Effect of Cold Vapor Inhalation on Dyspnea Thirst Nausea and Physiological Parameters in the Recovery Unit After Laparoscopic Inguinal Hernia Surgery
Cold vapor application is considered a promising intervention with the potential to alleviate side effects associated with anesthesia and surgery in the postoperative period. This study aims to determine the effect of cold vapor inhalation on dyspnea, thirst, nausea, and physiological parameters following laparoscopic inguinal hernia surgery.
Hypotheses (H1);
H1a: Patients administered cold vapor will report lower dyspnea severity compared to the control group.
H1b: Patients administered cold vapor will report lower thirst levels compared to the control group.
H1c: Patients administered cold vapor will report lower nausea severity compared to the control group.
H1d: Patients administered cold vapor will show significant differences in physiological parameters compared to the control group.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeliz SÜRME, Assoc. Prof. Dr.
- Phone Number: +90
- Email: yelizsurme@erciyes.edu.tr
Study Contact Backup
- Name: Ramazan SAKARYA
- Phone Number: +90
- Email: rs5800s.k.r.y@gmail.com
Study Locations
-
-
Kayseri
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Kayseri, Kayseri, Turkey (Türkiye), 38080
- Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Being aged 18 years or older
- Being able to speak and understand Turkish
- Having cognitive, affective, and communicative competence
- Having intact visual and auditory functions
- Having undergone elective laparoscopic inguinal hernia surgery under general anesthesia
- Having an ASA score of I or II
- Having a total Modified Aldrete Score of ≥9 and a consciousness score of 2 (fully awake) in the postoperative period
- Not having developed vomiting prior to the intervention
- Having a body temperature within the normal physiological range (36-37.5 °C)
Exclusion Criteria:
- Having cold vapor application planned by physician order in the PACU prior to the study
- Having signs and symptoms of upper or lower airway obstruction
- Developing agitation and having communication insufficiency
- Having an allergy to cold vapor application
- Having a diagnosis of obstructive pulmonary disease (e.g., COPD, asthma) or heart failure
- Having a known history of any neurological or psychiatric disease
- Having a postoperative nasogastric catheter inserted
- Having received preoperative diagnoses associated with nausea, vomiting, or dyspnea
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cold Vapor
Immediately following the initial (T0) assessment of patients, in addition to routine care and treatment procedures, patients will receive cold vapor using the Hikoneb 906 S/LCD ultrasonic hospital-grade nebulizer device for 15 minutes.
Following completion of the intervention, patients' status will be reassessed at 15 (T1) and 30 (T2) minutes.
|
Cold steam application will be performed using a Hikoneb 906 S/LCD ultrasonic nebulizer, which will generate cold steam with distilled water.
Device parameters will be optimally set to steam delivery level 5 (1-10), steam density level 5 (1-10), and steam temperature 1C0 (1C0-10C0).
This application will be applied to the intervention group for 15 minutes after the baseline (T0) assessment.
Cold steam will not be delivered directly to the airways but will be applied to the facial area, covering the mouth and nose area.
A distance of approximately 20-30 cm will be maintained between the device's steam outlet and the patient's face.
|
|
No Intervention: Control Group
Patients in the control group will not be subjected to any additional intervention.
Follow-up of patients in this group will be conducted in accordance with the clinic's current standard postoperative treatment and care practices, and patients will be evaluated at baseline (T0), 15 minutes (T1), and 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Borg Scale (MBS) for Dyspnea
Time Frame: Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
The MBS is a 12-point scale that rates dyspnea severity from 0 (no dyspnea) to 10 (intolerable dyspnea).
|
Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
|
Numerical Rating Scale (NRS) for Nausea Level
Time Frame: Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
The severity of postoperative nausea in patients will be assessed using the NRS, which is scored from 0 to 10 and created by researchers.
Higher scores on this scale represent higher severity of nausea.
|
Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
|
Surgical Period Thirst-Related Discomfort Scale (SPTRDS)
Time Frame: Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
This six-item, three-point Likert-type scale has a single-dimensional structure.
Items were rated as "did not bother" (0), "slightly bothered" (1), and "very bothered" (2).
Higher scores on this scale represent higher severity of thirst.
|
Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
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Survey Form
Time Frame: Baseline (T0)
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The form developed by the researchers consists of a total of 13 questions and collects data on the demographic (age (year), gender, body mass index (kg/m² ), ect.) and clinical characteristics (American Society of Anesthesiologists-ASA score, perioperative fasting period (min), ect.) of the patients.
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Baseline (T0)
|
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Physiological Parameter Monitoring Form (PPMF)
Time Frame: Baseline (T0), 15th minute (T1) and 30th minute (T2)
|
The monitoring form, created by the researcher as part of the study, will assess basic vital signs such as systolic (mmhg) and diastolic (mmhg) blood pressure, heart rate (pulse/min), peripheral oxygen saturation (SpO2, %) and respiratory rate (/min).
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Baseline (T0), 15th minute (T1) and 30th minute (T2)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-10/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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