Effects of Methods on Dry Mouth After Septoplasty Surgery

NCT06900621 | Not Yet Recruiting

• 1 other identifier: EGE-SBE-DPY-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

It was planned to investigate the effects of two different methods on early dry mouth after septoplasty surgery. The data of this study, which is planned to be conducted experimentally, is planned to be collected at Gönen State Hospital between 2025-2026. Patients who are scheduled to undergo septoplasty surgery and present with septum deviation constitute the universe of the study. The research sample (n: 63) was determined using the Power analysis G\*Power v3.1.9.7 program by taking the sample study as reference. However, considering the data losses (dropouts) in similar studies, when the missing data rate was taken as 20% , the sample size was determined as 81 patients. Patients who were informed about the study and volunteered to participate in the study (n: 81) and met the inclusion criteria of the study will constitute the sample group. 3 groups were determined in the study as intervention groups (group 1 and group 2) and control group (group 3). Patients who meet the preoperative criteria will be randomized into one of three groups after surgery. Data will be collected using the Patient Identification Form, General Patient Follow-up Form, Nasal Obstruction Symptom Assessment Scale (NOSE), Visual Analog Scale (VAS) scoring expressed by the patient to measure mouth dryness and satisfaction, "Safety Protocol for Thirst Management in the Immediate Postoperative Period" (SPTM), Oral Mucous Membrane Integrity Assessment and Follow-up Form - Oral Assessment Guide (OAG). 3 groups will be created in the study. 5 ml of ice water will be applied to one group that will receive intervention, the other group will be given water at normal room temperature, and the control group will receive standard clinical care and will not be treated. As a result of the evaluation made with SPTM in the first 30 minutes after the surgery, the dry mouth of all patients included in the study (Group 1, Group 2, Group 3) who meet the conditions will be evaluated before the application, starting from the first 30 minutes after the surgery and at 60 - 90 - 120 - 150 - 180 minutes. In the study, all patients (Group 1, Group 2, Group 3) will be evaluated for dry mouth before the application. The data obtained as a result of the study will be analyzed with a statistical package program. In the evaluation of the data in the study, descriptive statistics and parametric or non-parametric tests will be applied depending on whether the data show a normal distribution. In comparisons, p\<0.05 value will be considered statistically significant.

Conditions

Septoplasty; Dry Mouth

Keywords

dry mouth; nursing; early period; septoplasty; water at room temperature; ice water

Outcome Measures

Primary Outcomes (1)

• dry mouth

  Pre-Operative: Patients will be checked in terms of inclusion and exclusion criteria in the clinic and if they are suitable, they will be asked to participate in the study. The oral assessment guide (OAG) will be applied at this stage of the study. Patients who score 16 points or less in the OAG assessment (by the researcher using a light source and abeslang) will be included in the study. Before surgery, patients will be asked to fill out the Patient Identification Form. Then, the Nasal Obstruction Symptom Assessment Scale and the VAS scoring, expressed by the patient to measure dry mouth, will be performed and recorded in the general patient follow-up form. Post-operatively: starting from the first 30 minutes after the operation, and at 60-90-120-150-180 minutes, all patients included in the study (Group 1, Group 2, Group 3) will be evaluated for dry mouth before the application. Visual Analog Scale (VAS) will be used to determine dry mouth.

  The evaluation of dry mouth with VAS will be done once before the surgery and 6 times after the surgery and will take a total of 3-5 minutes.

Secondary Outcomes (1)

• patient satisfaction

  Patient satisfaction evaluation with VAS will be done after the application is completed only for Group 1 and Group 2 after the operation. It will take a maximum of 1 minute.

Study Arms (3)

Ice Water (Group 1)

ACTIVE COMPARATOR

Patients who come to the surgical clinic after the surgery will be given a VAS score for dry mouth at the 30th minute. Immediately afterwards, 5 ml of ice water (5-9 °C) placed in spray cans every 30 minutes will be sprayed into the mouth, tongue, palate, floor of the mouth, inside the right and left cheeks until all the water is used up. This application will be applied to the intervention groups a total of 5 times (30th min-60th min-90th min-120th min-150th min). VAS scoring will be done for dry mouth before each application. The first oral intake of the patients is routinely started at the 180th minute. After the applications are completed, VAS scoring will be requested for the satisfaction evaluation of the patients in the intervention group.

Other: ice water

Room Temperature Water (Group 2)

ACTIVE COMPARATOR

Patients who come to the surgical clinic after the surgery will be given a VAS score for dry mouth assessment at the 30th minute. Immediately afterwards, 5 ml of room temperature water (15-24 °C) placed in spray cans every 30 minutes will be sprayed into the mouth, tongue, palate, floor of the mouth, inside the right and left cheeks until all the water is used up. This application will be applied to the intervention groups a total of 5 times (30th min-60th min-90th min-120th min-150th min). VAS scoring will be done for dry mouth before each application. The first oral intake of the patients is routinely started at the 180th minute. After the applications are completed, VAS scoring will be requested for the satisfaction assessment of the patients in the intervention group.

Other: room temperature water

Control (Group 3)

NO INTERVENTION

The routine application in the clinic (oral intake restriction for 3 hours after surgery) will be applied to the control group. No application will be made, dry mouth will be evaluated at the specified times.

Interventions

ice water OTHER

Patients who apply SPTM are given a semifowler position with the head of the bed at least 45°, if there is no contraindication. The water temperature (5-9 °C) will be measured with a calibrated digital thermometer. After VAS scoring, patients are sprayed with 5 ml of ice water placed in spray cans every 30 minutes until all the water is used up in the mouth, tongue, palate, floor of the mouth, inside the right and left cheeks, depending on the group. A total of 5 rounds are made with 5 ml of water in one round (0.2 ml is sprayed on the tongue, palate, floor of the mouth, inside the right and left cheeks) and each round is planned to be completed in 1 minute and last at most 5 minutes. This application is applied to the intervention groups 5 times in total (30th min- 60th min- 90th min- 120th min- 150th min). The first oral intake of the patients is routinely started at the 180th minute.

Ice Water (Group 1)

room temperature water OTHER

Patients who apply SPTM are given a semifowler position with the head of the bed at least 45°, if there is no contraindication. The water temperature (15-24 °C) will be measured with a calibrated digital thermometer. After VAS scoring, patients are sprayed with 5 ml of room temperature water placed in spray cans every 30 minutes until all the water is used up in the mouth, tongue, palate, floor of the mouth, inside the right and left cheeks, depending on the group. A total of 5 rounds are made with 5 ml of water in one round (0.2 ml is sprayed on the tongue, palate, floor of the mouth, inside the right and left cheeks) and each round is planned to be completed in 1 minute and last at most 5 minutes. This application is applied to the intervention groups 5 times in total (30th min- 60th min- 90th min- 120th min- 150th min). The first oral intake of the patients is routinely started at the 180th minute.

Room Temperature Water (Group 2)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 89
• Able to communicate in Turkish
• No obstacle to communication
• Agreeing to participate in the study
• Conscious and oriented as a result of the evaluation made with SPMT at 30 minutes after the surgery, with a clear airway, no nausea or vomiting
• Using silicone nasal tampons

You may not qualify if:

• Patients with a preoperative oral mucous membrane integrity assessment Oral Assessment Guide (OAG) result of over 16
• Those taking medication that affects dry mouth
• Those with a chronic disease that affects dry mouth
• Those undergoing a second simultaneous surgical procedure
• Those who develop complications during surgery and/or during recovery from anesthesia
• Patients who smoke will not be included in the study.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Gönen State Hospital

Balıkesir, Gönen, 10900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Xerostomia

Interventions

major intrinsic protein, plant

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Eda Dolgun, Ass. Prof.

  Ege University

  STUDY DIRECTOR

Central Study Contacts

Dürdane Palabıyık Yılmaz, PhD Student

CONTACT

+905309597629; durdanepalabiyikyilmaz@gmail.com

Eda Dolgun, Ass. Prof.

CONTACT

+905326681626; eda.dolgun@ege.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The instructions given to the participants during the application process were designed in line with the blinding principles and aimed to prevent information leakage regarding which group the participants belonged to. During the data collection phase, the group information of the participants was recorded, but this information was not used during the analysis phase, ensuring that the blinding status was maintained. For blinding, a separate envelope containing each block code was prepared and a unique code indicating which block it belonged to was added to each envelope. The blocks were arranged in a randomized order and the envelopes belonging to each block were arranged according to this order. This process ensured that the participants in each block were randomly assigned to the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: This study was planned as an experimental, randomized controlled, single-blind study.Patients who meet the postoperative criteria will be randomized to one of three groups. Randomization was performed as a 3-way block randomization (Sealed Envelope Ltd. 2022). In the study, 3-way block randomization was applied using a blind technique. 3 participants in each block were assigned to different groups in a randomized order. The group codes determined in accordance with the randomization list were used to assign participants to the experimental conditions. This randomization method was preferred in order to provide balance between the participant groups and to minimize the potential effects of external factors.

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 28, 2025
• Study Start: March 25, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)