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

NCT02869139 | Completed DMC

• 1 other identifier: GPS Menthol
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial

Conditions

Thirst; Mouth Dryness; Irritation Lips

Keywords

Thirst; Ice; Menthol; Perioperative Nursing.; Recovery Room

Outcome Measures

Primary Outcomes (1)

• 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).

  three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation

Secondary Outcomes (1)

• 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.

  three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation

Study Arms (2)

Package of mentholated measures

EXPERIMENTAL

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

Other: Mentholated lip moisturizer and ice popsicle

Package of non-mentholated measures

ACTIVE COMPARATOR

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

Other: Non-mentholated lip moisturizer and ice popsicle

Interventions

Mentholated lip moisturizer and ice popsicle OTHER

Mentholated package of measures

Package of mentholated measures

Non-mentholated lip moisturizer and ice popsicle OTHER

Non-mentholated package of measures

Package of non-mentholated measures

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

Viviane Moreira Serato

Londrina, Paraná, 86039-290, Brazil

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Viviane Serato

  Universidade Estadual de Londrina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master's degree in Nursing

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 16, 2016
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)