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

NCT03215251 | Completed DMC

• 1 other identifier: 773
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thirst; Dry Mouth

Keywords

Thirst, Dry Mouth, Intervention Bundle

Outcome Measures

Primary Outcomes (2)

• Thirst intensity Scale

  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

  10 minutes

• Dry Mouth assessment scale

  to assess dry mouth

  5 minutes

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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

CONTROL GROUP

NO INTERVENTION

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

Interventions

Intervention bundle OTHER

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.

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Related Publications (4)

• 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.

  PMID: 24894026 BACKGROUND

• 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.

  PMID: 24136996 BACKGROUND

• 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.

  PMID: 11246306 BACKGROUND

• 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.

  PMID: 25116914 RESULT

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mrs. Vinay Kumari, M.Sc Nursing

  M.M University, Mullana, Ambala, Haryana, India

  STUDY DIRECTOR

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: Student, M.Sc Nursing

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 12, 2017
• Study Start: November 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07