The Effect of Cold Water Spray Application on Dry Mouth and Thirst Symptoms and Comfort of Patients After Endonasal Endoscopic Surgery After Admission to Intensive Care Unit

NCT06763133 | Completed

• 1 other identifier: SaglikBilimleriU-SBF-DO-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study was to evaluate the effect of cold water spray application on dry mouth and thirst symptoms and comfort of patients who underwent endonasal endoscopic pituitary surgery in neurosurgery in the first 24 hours after admission to intensive care unit. The main questions it aims to answer are as follows: H0.1: Cold water spray application has no effect on dry mouth symptoms. H1.1: The cold water spray application has an effect on the dry mouth symptom. H0.2: The cold water spray application has no effect on the thirst symptom. H1.2: Cold water spray application has an effect on thirst symptom. H0.3: Cold water spray application has no effect on oral health. H1.3: Cold water spray application has an effect on oral health. H0.4: Cold water spray application has no effect on patient comfort. H1.4: Cold water spray application has an effect on patient comfort. The research sample will be divided into two as treatment and control groups. A web-based random sample selection will be made to determine the patients to be included in the research groups. Cold water spray will be applied to the treatment group and their data will be recorded. Clinical routine will continue to be applied to the control group.

Conditions

Thirst in Intensive Care Unit (ICU) Practice; Thirst; Due to Deprivation of Water; Thirst; Dry Mouth; Comfort

Keywords

Endonasal Endoscopic Surgery; Postoperative Nursing; Thirst; Cold Water; Spray; Oral Care; Comfort; Nose Tampon

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Feeling of Thirst and Dry Mouth Experienced by Patients in the First 24 Hours After Surgery

  To assess thirst status, a numerical assessment scale numbered 0-10 will be used, where 0: no thirst, 10: unbearable thirst (1-3 mild, 4-6 moderate, 7-10 severe). To assess dry mouth: a numerical rating scale numbered 0-10 will be used, where 0: no dry mouth, 10: unbearable dry mouth (1-3 mild, 4-6 moderate, 7-10 severe). The Oral Health Assesment Tool will be used to assess oral status. The original scale consists of eight categories: lips, tongue, gums and mucosa, saliva, teeth, presence of dentures, oral hygiene, and toothache. The lowest score to be obtained from the scale is 0, while the highest score is 16. Scores can vary between 0-very healthy and 16-very unhealthy. In this study, the first four items of the scale, which are 'lips, tongue, gums-mucosa, and saliva' categories, will be used. In this case, the lowest score to be obtained from the scale will be 0, while the highest score will be evaluated as 8. The validity and reliability of the OHAT in Turkish has been conducted

  Within the first 24 hours postoperatively, evaluations will be made at the 1st, 2nd, 4th, 8th and 24th hours.

Secondary Outcomes (1)

• Evaluation of Patient Comfort When Leaving the Intensive Care Unit After 24 Hours Postoperatively

  At the end of the 24th postoperative hour, before the patient leaves the intensive care unit

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients in this group will receive cold water application in the form of a spray (6 times every half hour) and oral care (2 times a day, at 22.00 pm and 07.00 am, using an oral care solution containing 0.25% chlorhexidine gluconate approved by the Ministry of Health and an oral care stick, and moisturizing the lips with a lip moisturizer containing glycerin as the main component).

Other: Cold Water Spray Application

Control Group

OTHER

Patients in this group will be given 2 cc of water at room temperature into the patient's mouth with the syringe routinely applied for mouth wetting in the clinic (1 time every hour) and oral care (2 times a day, at 22:00 in the evening and 07:00 in the morning, using oral care solution containing 0.25% chlorhexidine gluconate approved by the Ministry of Health and oral care stick, and moisturizing the lips with lip moisturizer with glycerin as the main component).

Other: Clinical routine practice

Interventions

Cold Water Spray Application OTHER

Cold water spray application after endonasal endoscopic surgery.

Experimental Group

Clinical routine practice OTHER

The process of giving 2 cc of water to patients with a syringe as a clinical routine practice.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who agreed to participate in the study,
• Patients over 18 years of age,
• Patients with endonasal endoscopic surgery and nasal tampons,
• Patients who can communicate verbally,
• Patients with a Glasgow Coma Scale score of 15 before and after surgery.

You may not qualify if:

• Patients who refused to participate in the study,
• Patients under 18 years of age,
• Patients who require respiratory support after surgical intervention and need intubation,
• Patients undergoing surgery that may interfere with oral assessment,
• Patients with a postoperative Glasgow Coma Scale score of 14 or less,
• Patients with Diabetes Mellitus and Xerostomia.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Model Details: Patient groups Experimental Group: Patients in this group will receive cold water application in the form of a spray (6 times every half hour) and oral care (2 times a day, at 22.00 pm and 07.00 am, using an oral care solution containing 0.25% chlorhexidine gluconate approved by the Ministry of Health and an oral care stick, and moisturizing the lips with a lip moisturizer containing glycerin as the main component). Control Group: Patients in this group will be given 2 cc of water at room temperature into the patient's mouth with the syringe routinely applied for mouth wetting in the clinic (1 time every hour) and oral care (2 times a day, at 22:00 in the evening and 07:00 in the morning, using oral care solution containing 0.25% chlorhexidine gluconate approved by the Ministry of Health and oral care stick, and moisturizing the lips with lip moisturizer with glycerin as the main component).

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start: January 10, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

TU (1)