search
Back to results

Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room

Primary Purpose

Thirst, Mouth Dryness, Irritation Lips

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mentholated lip moisturizer and ice popsicle
Non-mentholated lip moisturizer and ice popsicle
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thirst focused on measuring Thirst, Ice, Menthol, Perioperative Nursing., Recovery Room

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Possess aged between eighteen and sixty-five years
  • To be fasting for more than four hours
  • Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale
  • Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia
  • Being in anesthetic recovery in anesthesia recovery room
  • Have been approved in the evaluation Headquarter Insurance Management Protocol which was applied to both groups
  • Accept participate and sign the consent form Clarified

Exclusion Criteria:

  • Being allergic to menthol
  • Have continuity of injury in the oral mucosa
  • Having suspended the anesthetic-surgical procedure after acceptance of participation
  • Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit

Sites / Locations

  • Viviane Moreira Serato

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Package of mentholated measures

Package of non-mentholated measures

Arm Description

Package of mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group.

Package of non-mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group.

Outcomes

Primary Outcome Measures

Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups.
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).

Secondary Outcome Measures

Change in the extent of satiety point over an hour assessment, presented by experimental and control groups, and the number of interventions required in every moment of assessment and intervention for each group.
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).

Full Information

First Posted
August 8, 2016
Last Updated
August 11, 2016
Sponsor
Universidade Estadual de Londrina
search

1. Study Identification

Unique Protocol Identification Number
NCT02869139
Brief Title
Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room
Official Title
Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial
Detailed Description
Perioperative thirst is intense and has a high incidence. There is evidence that strategies using cold and menthol could be viable alternatives to reduce thirst and the discomforts arising from it. For that reason, this study evaluated the efficacy of a mentholated package of measures (lip moisturizer and ice popsicle) compared to a non-mentholated package of measures in alleviating thirst in the anesthesia recovery room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thirst, Mouth Dryness, Irritation Lips
Keywords
Thirst, Ice, Menthol, Perioperative Nursing., Recovery Room

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Package of mentholated measures
Arm Type
Experimental
Arm Description
Package of mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group.
Arm Title
Package of non-mentholated measures
Arm Type
Active Comparator
Arm Description
Package of non-mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group.
Intervention Type
Other
Intervention Name(s)
Mentholated lip moisturizer and ice popsicle
Intervention Description
Mentholated package of measures
Intervention Type
Other
Intervention Name(s)
Non-mentholated lip moisturizer and ice popsicle
Intervention Description
Non-mentholated package of measures
Primary Outcome Measure Information:
Title
Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups.
Description
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).
Time Frame
three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
Secondary Outcome Measure Information:
Title
Change in the extent of satiety point over an hour assessment, presented by experimental and control groups, and the number of interventions required in every moment of assessment and intervention for each group.
Description
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).
Time Frame
three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Possess aged between eighteen and sixty-five years To be fasting for more than four hours Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia Being in anesthetic recovery in anesthesia recovery room Have been approved in the evaluation Headquarter Insurance Management Protocol which was applied to both groups Accept participate and sign the consent form Clarified Exclusion Criteria: Being allergic to menthol Have continuity of injury in the oral mucosa Having suspended the anesthetic-surgical procedure after acceptance of participation Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viviane Serato
Organizational Affiliation
Universidade Estadual de Londrina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Viviane Moreira Serato
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86039-290
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room

We'll reach out to this number within 24 hrs