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Completed

NCT Number: NCT05317520

The Effect of Cold Vapor Application on Postoperative Sore Throat

To determine the effect of cold vapor given in the post-extubation period on sore throat.

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Key information

Conditions

Sore Throat Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatice Özsoy

Merkez, Burdur, Turkey (Türkiye)

About this study

General anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. The necessity of intubation is known in patients who have undergone surgery under general anesthesia. Intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem.

Although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia.

Although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. With this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who accept the research
  • Elective laparoscopic cholecystectomy surgery planned
  • Patients in ASA I and II class
  • 18 years and over
  • Mallampati classification I and II
  • Operation time more than 30 minutes
  • Literate
  • No hearing problem
  • Patients without understanding difficulties

Exclusion criteria

  • Overweight patients (Body Mass Index ≥ 40)
  • Patients with sore throat and lower respiratory tract infection
  • Patients with Chronic Obstructive Pulmonary Disease (COPD)
  • Patients with a history of allergies
  • Patients with hearing problems
  • illiterate patients
  • ASA classification III and above
  • Mallampati classification III and IV patients
  • Patients with an operation time of less than 30 minutes

Treatment and study plan

Cold vapor

Procedure

The Ramsey Sedation Scale was used to assess wakefulness after patients were extubated and arrived at the recovery unit at the 0th hour postoperatively. Sore throat, localization of pain, hoarseness, dry throat, and swallowing difficulty were evaluated in patients with a score of 2 according to this scale. Sore throat of the patients was evaluated with Numerical Rating Scale. Then, cold vapor was applied for 15 minutes with a vapor machine used as a standard in the hospital by the researcher. After the cold vapor application was finished, the patients' sore throat, localization of pain, hoarseness, swallowing difficulty and dry throat were re-evaluated with the same forms.

Sore throat were evaluated before the application of cold vapor at the 2nd and 6th hours. Then cold vapor was applied for 15 minutes. After the cold vapor application was finished, sore throat were re-evaluated.

At the 24th hour, cold vapor was not applied to the patients. Only sore throat were evaluated.

Primary outcomes

  1. Sore throat

    Time frame: Within an hour after surgery

    In our study, a horizontally prepared Numerical Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of their sore throat on a scale of 0 to 10. The scale begins with the absence of pain (0) and ends with excruciating pain (10).

    When the patient came to the recovery unit, the severity of sore throat was evaluated before and after the application of cold vapor at 0th hour.

  2. Sore throat

    Time frame: 2nd hour after surgery

    In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10).

    The severity of sore throat was evaluated before and after the application of cold vapor at 2nd hour postoperatively.

  3. Sore throat

    Time frame: 6th hour after surgery

    In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10).

    The severity of sore throat was evaluated before and after the application of cold vapor at 6th hour postoperatively.

  4. Sore throat

    Time frame: 24th hour after surgery

    In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10).

    Cold vapor was not applied to the patients at the 24th hour.. Only sore throat were evaluated.

Secondary outcomes

  1. Hoarseness

    Time frame: Within an hour after surgery

    To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating.Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).

    When the patient came to the recovery unit, the severity of hoarseness was evaluated before and after the application of cold vapor at the 0th hour.

  2. Hoarseness

    Time frame: 2nd hour after surgery

    To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).

    The severity of hoarseness was evaluated before and after the application of cold vapor at the 2nd hour postoperatively.

  3. Hoarseness

    Time frame: 6th hour after surgery

    To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).

    The severity of hoarseness was evaluated before and after the application of cold vapor at the 6th hour postoperatively.

  4. Hoarseness

    Time frame: 24th hour after surgery

    To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech).

    Cold vapor was not applied to the patients at the 24th hour. Only hoarseness was evaluated.

  5. Dry throat and swallowing difficulty

    Time frame: Within an hour after surgery

    The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).

    When the patient came to the recovery unit, the severity of throat dryness and swallowing difficulty was evaluated before and after the application of cold vapor at the 0th hour.

  6. Dry throat and swallowing difficulty

    Time frame: 2nd hour after surgery

    The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).

    At the 2nd hour postoperatively, the severity of throat dryness and swallowing difficulty were evaluated before and after the application of cold vapor.

  7. Dry throat and swallowing difficulty

    Time frame: 6th hour after surgery

    The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).

    At the 6th hour postoperatively, the severity of throat dryness and swallowing difficulty were evaluated before and after the application of cold vapor.

  8. Dry throat and swallowing difficulty

    Time frame: 24th hour after surgery

    The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable).

    Cold vapor was not applied to the patients at the 24th hour. Only dry throat and swallowing difficulty were evaluated.

Sponsors and collaborators

Lead sponsor

Burdur Mehmet Akif Ersoy University

Other

Registry information

Official study title

The Effect of Cold Vapor Application on Sore Throat in The Patients Extubated After Surgery: A Randomized Control Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 7, 2022
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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