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Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs

Primary Purpose

Thirst, Dry Mouth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention bundle
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thirst focused on measuring Thirst, Dry Mouth, Intervention Bundle

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 or above 18 years of age.
  2. Having thirst score ≥ 5 and dry mouth score ≥ 1
  3. Willing to participate in the study.
  4. Able to report verbally or non verbally about thirst intensity.
  5. Admitted in ICCU,Respiratory ICU, Neurosurgical ICU and step Up ICU

Exclusion Criteria:

  1. On mechanical ventilation.
  2. Not able to follow the commands.
  3. Having any oral surgery
  4. Having open sores or desquamation of mouth and lips

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    EXPERIMENTAL GROUP

    CONTROL GROUP

    Arm Description

    Intervention bundle consisted of sterile cold wet oral swab wipes and sterile ice cold water sprays administered in two sessions of 15 minutes each. First session was given in 15 minutes, patients received cold wet oral swab wipes in oral cavity 2 to 3 times and mouth spray with 5 to 6 sprays. A maximum of 9 wipes and 18 sprays of sterile water. After administration of intervention bundle, Posttest 1 was taken after 15 minutes observation with the same tools. Then researcher waited for 15 minutes after post test1 and session two was administered in 15 minutes with a maximum of 9 wipes and 18 sprays of sterile water. Post test 2 was taken after 15 minutes of session two.

    No Intervention administered. Thirst and Dry mouth scores were assessed only. Usual care was continued.

    Outcomes

    Primary Outcome Measures

    Thirst intensity Scale
    To assess thirst intensity The scoring in the scale is given : not thirsty at all not very thirsty not thirsty neutral thirsty very thirsty very very thirsty
    Dry Mouth assessment scale
    to assess dry mouth

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2017
    Last Updated
    July 11, 2017
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03215251
    Brief Title
    Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs
    Official Title
    Experimental Study to Evaluate the Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients of Selected Units
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be University)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study evaluates the effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth among Patients admitted in ICUs. Patients were randomized into two groups - Experimental and Control group. Experimental group received intervention Bundle whereas control group didn't receive any intervention. Usual care was continued in both the groups.
    Detailed Description
    The Convenience sampling technique was used to select Maharishi Markandeshwar institution of Medical Science and Researches Hospital, Mullana, Ambala. Intensive Care Units and a total of 60 patients in those units were also selected conveniently. The selected patients were randomly assigned to experimental and control group using lottery method. The total sample size for the study was 60 patients i.e. - 30 in experimental group and 30 in control group. Experimental Group -patients were explained regarding administration of intervention bundle.Assessment of patients' mouth and lips was determined firstly. Intervention bundle consisted of sterile cold wet oral swab wipes and sterile ice cold water sprays administered for in two sessions of 15 minutes each. First session was given in 15 minutes, patients received cold wet oral swab wipes in oral cavity 2 to 3 times and mouth spray with 5 to 6 sprays. A maximum of 9 wipes and 18 sprays of sterile water. After administration of intervention bundle, Post test 1 was taken after 15 minutes observation with the same tools. Then researcher waited for 15 minutes after post test1 and session two was administered in 15 minutes with a maximum of 9 wipes and 18 sprays of sterile water. Post test 2 was taken after 15 minutes of session two. Control group: control group was not given any intervention. Sample characteristics and clinical data (variables) were recorded in record sheet and thirst intensity and dry mouth scores were assessed only. After 30 minutes of pre test scores, post test 1 was taken and data were recorded. Then after, 30 minutes of post test 1, post test 2 was taken and data were recorded. (Intervention to the control group was given after accomplishment of Post test for ethical consideration).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thirst, Dry Mouth
    Keywords
    Thirst, Dry Mouth, Intervention Bundle

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    EXPERIMENTAL GROUP
    Arm Type
    Experimental
    Arm Description
    Intervention bundle consisted of sterile cold wet oral swab wipes and sterile ice cold water sprays administered in two sessions of 15 minutes each. First session was given in 15 minutes, patients received cold wet oral swab wipes in oral cavity 2 to 3 times and mouth spray with 5 to 6 sprays. A maximum of 9 wipes and 18 sprays of sterile water. After administration of intervention bundle, Posttest 1 was taken after 15 minutes observation with the same tools. Then researcher waited for 15 minutes after post test1 and session two was administered in 15 minutes with a maximum of 9 wipes and 18 sprays of sterile water. Post test 2 was taken after 15 minutes of session two.
    Arm Title
    CONTROL GROUP
    Arm Type
    No Intervention
    Arm Description
    No Intervention administered. Thirst and Dry mouth scores were assessed only. Usual care was continued.
    Intervention Type
    Other
    Intervention Name(s)
    Intervention bundle
    Intervention Description
    Assessment of the patient's mouth and lips determined, to check any stickiness or dryness in the mouth or around lips or split skin at the corners of the mouth or cracked lips. Intervention bundle consisted of sterile cold wet oral swab wipes and sterile ice cold water sprays administered for in two sessions of 15 minutes each. First session was given in 15 minutes, patients received cold wet oral swab wipes in oral cavity 2 to 3 times and mouth spray with 5 to 6 sprays. A maximum of 9 wipes and 18 sprays of sterile water. After administration of intervention bundle, Posttest 1 was taken after 15 minutes observation with the same tools. Then researcher waited for 15 minutes after post test1 and session two was administered in 15 minutes with a maximum of 9 wipes and 18 sprays of sterile water. Post test 2 was taken after 15 minutes of session two.
    Primary Outcome Measure Information:
    Title
    Thirst intensity Scale
    Description
    To assess thirst intensity The scoring in the scale is given : not thirsty at all not very thirsty not thirsty neutral thirsty very thirsty very very thirsty
    Time Frame
    10 minutes
    Title
    Dry Mouth assessment scale
    Description
    to assess dry mouth
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 or above 18 years of age. Having thirst score ≥ 5 and dry mouth score ≥ 1 Willing to participate in the study. Able to report verbally or non verbally about thirst intensity. Admitted in ICCU,Respiratory ICU, Neurosurgical ICU and step Up ICU Exclusion Criteria: On mechanical ventilation. Not able to follow the commands. Having any oral surgery Having open sores or desquamation of mouth and lips
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mrs. Vinay Kumari, M.Sc Nursing
    Organizational Affiliation
    M.M University, Mullana, Ambala, Haryana, India
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24894026
    Citation
    Puntillo K, Arai SR, Cooper BA, Stotts NA, Nelson JE. A randomized clinical trial of an intervention to relieve thirst and dry mouth in intensive care unit patients. Intensive Care Med. 2014 Sep;40(9):1295-302. doi: 10.1007/s00134-014-3339-z. Epub 2014 Jun 4.
    Results Reference
    background
    PubMed Identifier
    24136996
    Citation
    Arai SR, Butzlaff A, Stotts NA, Puntillo KA. Quench the thirst: lessons from clinical thirst trials. Biol Res Nurs. 2014 Oct;16(4):456-66. doi: 10.1177/1099800413505900. Epub 2013 Oct 16.
    Results Reference
    background
    PubMed Identifier
    11246306
    Citation
    Nelson JE, Meier DE, Oei EJ, Nierman DM, Senzel RS, Manfredi PL, Davis SM, Morrison RS. Self-reported symptom experience of critically ill cancer patients receiving intensive care. Crit Care Med. 2001 Feb;29(2):277-82. doi: 10.1097/00003246-200102000-00010.
    Results Reference
    background
    PubMed Identifier
    25116914
    Citation
    Stotts NA, Arai SR, Cooper BA, Nelson JE, Puntillo KA. Predictors of thirst in intensive care unit patients. J Pain Symptom Manage. 2015 Mar;49(3):530-8. doi: 10.1016/j.jpainsymman.2014.07.001. Epub 2014 Aug 10.
    Results Reference
    result

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    Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs

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