NCT06171347

Brief Summary

The aim of this study was to determine the effect of oral cold water spray application on thirst severity and patient satisfaction after spinal surgery. H1: Oral cold water spray application has an effect on thirst severity after spinal surgery. H2: Oral cold water spray application has an effect on salivary pH after spinal surgery. H3: Oral cold water spray application affects the satisfaction of patients after spinal surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 27, 2023

Last Update Submit

December 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • thirst

    to determine the effect of oral cold water spray application on the severity of thirst after spinal surgery. Thirst severity and discomfort levels of the patients will be evaluated numerically four times and salivary pH levels will be evaluated twice (before the first application and 1 hour after the end of all applications) with the chart (Visual Analogue Scale values) at the end of the "Postoperative patient follow-up form". The Visual Analogue Scale, which is used to convert data that cannot be evaluated numerically into numerical form, is 10 cm long and is graded on a horizontal or vertical line. Since thirst is a state of discomfort consisting of subjective experiences expressed by the person, it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies.

    postoperative period (2., 2.5, 4. and 4.5. hours)

Secondary Outcomes (1)

  • satisfaction of patients

    postoperative period (6.hour)

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients in the experimental group will receive oral cold spray (tap water) in the postoperative period.

Other: Oral cold spray (tap water)

Control group

NO INTERVENTION

Patients in the control group will not be intervened in the postoperative period except for standard care for thirst management.

Interventions

Oral cold spray (tap water)

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient treatment in the neurosurgery ward,
  • undergoing planned spinal surgery under general anaesthesia,
  • Admitted to the ward after surgery,
  • Who volunteered to participate in the research,
  • No mental disability,
  • years of age,
  • Literate,
  • Accepting random selection,
  • Patients without communication problems in Turkish

You may not qualify if:

  • Spinal surgery performed under spinal anaesthesia,
  • Admitted to intensive care or external ward after surgery,
  • Emergency surgery,
  • not volunteering to participate in the research,
  • Mentally handicapped,
  • Under 18 years of age,
  • Illiterate,
  • which does not accept random selection,
  • Patients with communication problems in Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Trakya University

Edirne, 22030, Turkey (Türkiye)

RECRUITING

Central Study Contacts

ZEYNEP KIZILCIK ÖZKAN

CONTACT

Emine KOÇ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data will be collected and coded by the nurse researcher. Data will be analyzed by an independent statistician. The study groups will be disguised as A and B. The statistician will not know the groups. In addition, the statistical expert will not see the data of the experimental group regarding satisfaction.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients in the experimental group will receive oral cold spray in the postoperative period. Patients in the control group will receive standard care in the postoperative period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 14, 2023

Study Start

December 1, 2023

Primary Completion

March 31, 2024

Study Completion

August 31, 2024

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations