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

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ClinicalTrials.gov Identifier: NCT03215251
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Shikha Gulia, Maharishi Markendeswar University

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 12, 2017
Last Update Posted Date July 12, 2017
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
  • Thirst intensity Scale [ Time Frame: 10 minutes ]
    To assess thirst intensity The scoring in the scale is given :
    1. not thirsty at all
    2. not very thirsty
    3. not thirsty
    4. neutral
    5. thirsty
    6. very thirsty
    7. very very thirsty
  • Dry Mouth assessment scale [ Time Frame: 5 minutes ]
    to assess dry mouth
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs
Official Title  ICMJE Experimental Study to Evaluate the Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients of Selected Units
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thirst
  • Dry Mouth
Intervention  ICMJE Other: Intervention bundle
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.
Study Arms  ICMJE
  • Experimental: EXPERIMENTAL GROUP
    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.
    Intervention: Other: Intervention bundle
  • No Intervention: CONTROL GROUP
    No Intervention administered. Thirst and Dry mouth scores were assessed only. Usual care was continued.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2017)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03215251
Other Study ID Numbers  ICMJE 773
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shikha Gulia, Maharishi Markendeswar University
Study Sponsor  ICMJE Maharishi Markendeswar University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mrs. Vinay Kumari, M.Sc Nursing M.M University, Mullana, Ambala, Haryana, India
PRS Account Maharishi Markendeswar University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP