The Effect of Cold Vapor on Dyspnea, Thirst, Nausea, and Physiological Parameters in the PACU After Laparoscopic Inguinal Hernia Surgery

NCT07273162 | Not Yet Recruiting

• 1 other identifier: 2025-10/14
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Laparoscopic Inguinal Hernia Repair

Keywords

PACU; Laparoscopy; inguinal hernia; cold vapor; dyspnea; thirst; nausea; physiological parameters; surgery

Outcome Measures

Primary Outcomes (5)

• Survey Form

  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.

  Baseline (T0)

• Modified Borg Scale (MBS) for Dyspnea

  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

  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)

  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)

• Physiological Parameter Monitoring Form (PPMF)

  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).

  Baseline (T0), 15th minute (T1) and 30th minute (T2)

Study Arms (2)

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.

Other: Cold Vapor

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.

Interventions

Cold Vapor OTHER

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.

Cold Vapor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Inguinal; Dyspnea; Nausea

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

Yeliz SÜRME, Assoc. Prof. Dr.

CONTACT

+90; yelizsurme@erciyes.edu.tr

Ramazan SAKARYA

CONTACT

+90; rs5800s.k.r.y@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No information regarding group allocations will be shared with the expert statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)