Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort

NCT06857760 | Recruiting

• 1 other identifier: A.30.2.ODM.0.20.08/569-677
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery.

Conditions

Spinal Surgery

Keywords

nausea, thirst, comfort

Outcome Measures

Primary Outcomes (3)

• Nausea

  Nausea level: It consists of a numeric scale. Among the numbers, ''0'' corresponds to ''no thirst/nausea'' and ''10'' corresponds to ''very much thirst/nausea''. As the number increases, nausea and thirst will be accepted as increased. There is no cut-off point.

  once before the application and 60, 120, 180 and 240 min. after arrival at the clinic

• Thirst

  Thirst level: A minimum score of 12 and a maximum score of 60 can be obtained from the scale. The higher the score obtained from the scale, the higher the level of thirst discomfort of the patients.

  once before the application and 60, 120, 180 and 240 min. after arrival at the clinic

• Comfort

  Comfort level: The highest score that can be obtained from the scale is 192 and the lowest score is 48. A high SCS scoring indicates a high comfort level of the individual.

  once before the application and 240 min. after arrival at the clinic

Study Arms (4)

Control group

NO INTERVENTION

Routine care

Ice cube

EXPERIMENTAL

Other: Ice cube

Mouth wash

EXPERIMENTAL

Other: Mouth wash

Menthol lozenge

EXPERIMENTAL

Other: Menthol lozenge

Interventions

Ice cube OTHER

ıce cube

Ice cube

Mouth wash OTHER

Mouth wash

Mouth wash

Menthol lozenge OTHER

menthol lozenge

Menthol lozenge

Eligibility Criteria

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

You may qualify if:

• Adult patients who underwent lumbar disc herniation (LDH) surgery
• LDH surgery patients who recieve general anesthesia
• The patients who were conscious
• The duration of surgery is between 0-3 hours

You may not qualify if:

• Patients who cannot understand and speak Turkish
• Allergic patients to menthol
• Patients who received spinal anesthesia
• Patients with lesions on the oral mucosa and lips
• Patients requiring intensive care after surgical intervention

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Amasya Şerefeddin Sabuncuoğlu Hospital

Amasya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Nausea

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Özge İşeri, PhD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özge İşeri Özge İşeri, Assistant Professor, PhD

CONTACT

03623121919; ozgepekiniseri@gmail.com

Ayşe Kale Postgraduate doctorate student, RN, MSc

CONTACT

ayse.kale@amasya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Ondokuz Mayıs University

Model Details: Randomized clinical trials

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 4, 2025
• Study Start: February 21, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

TU (1)