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Clinical Trials/NCT07273162
NCT07273162
Not yet recruiting
Not Applicable

The Effect of Cold Vapor Inhalation on Dyspnea Thirst Nausea and Physiological Parameters in the Recovery Unit After Laparoscopic Inguinal Hernia Surgery

TC Erciyes University1 site in 1 country66 target enrollmentStarted: December 20, 2025Last updated:
InterventionsCold Vapor

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
66
Locations
1
Primary Endpoint
Survey Form

Overview

Brief Summary

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.

Detailed Description

Non-pharmacological methods, such as cold vapor application, hold significant potential in the management of complications encountered in the postoperative period. Despite this potential, to the best of our knowledge, no published study examining the effect of cold vapor on dyspnea, thirst, and physiological parameters has been found in the literature. This study is a randomized controlled experimental study. The study will be conducted with at least 66 patients in total, including 33 in the intervention group and 33 in the control group. Data collection consists of three stages: T0, T1, and T2. In these stages, the baseline (T0) assessment of both groups will be performed using the Questionnaire Form, Modified Borg Scale (MBS), Perioperative Thirst Discomfort Scale (PTDS), Numerical Rating Scale (NRS), and Physiological Parameter Follow-up Form (PPFF). Following this assessment, the patients' condition will be re-evaluated at the 15th minute (T1) and 30th minute (T2) using the MBS, PTDS, NRS, and PPFF. In the intervention group, immediately after the baseline (T0) assessment, cold steam application will be administered to patients for 15 minutes using a Hikoneb 906 S/LCD ultrasonic hospital-type nebulizer device, in addition to routine care and treatment procedures. Patients in the control group will not be subjected to any additional intervention. It is predicted that cold vapor inhalation will reduce the severity of dyspnea, thirst, and nausea after laparoscopic inguinal hernia surgery as a result of the study. Additionally, it is expected to bring basic vital parameter values such as systolic and diastolic blood pressure, heart rate (pulse/min), peripheral oxygen saturation (SpO2, %), and respiratory rate (/min) closer to the normal physiological range. This study is significant as it demonstrates the value of cold vapor as a practice that strengthens and supports individualized nursing care in the early postoperative period.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

No information regarding group allocations will be shared with the expert statistician.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Cold Vapor

Experimental

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.

Intervention: Cold Vapor (Other)

Control Group

No Intervention

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.

Outcomes

Primary Outcomes

Survey Form

Time Frame: Baseline (T0)

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.

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).

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).

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yeliz Sürme

Assoc. Prof. Dr.

TC Erciyes University

Study Sites (1)

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