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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

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.

Condition or disease Intervention/treatment Phase
Thirst Dry Mouth Other: Intervention bundle Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Experimental Study to Evaluate the Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients of Selected Units
Actual Study Start Date : November 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
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.
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.

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



Primary Outcome Measures :
  1. 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

  2. Dry Mouth assessment scale [ Time Frame: 5 minutes ]
    to assess dry mouth



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215251


Sponsors and Collaborators
Maharishi Markendeswar University
Investigators
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Study Director: Mrs. Vinay Kumari, M.Sc Nursing M.M University, Mullana, Ambala, Haryana, India

Publications of Results:
Other Publications:
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Responsible Party: Shikha Gulia, Student, M.Sc Nursing, Maharishi Markendeswar University
ClinicalTrials.gov Identifier: NCT03215251     History of Changes
Other Study ID Numbers: 773
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shikha Gulia, Maharishi Markendeswar University:
Thirst, Dry Mouth, Intervention Bundle
Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases