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

Not Applicable

Completed

• Conditions: Thirst; Dry Mouth
• Interventions: Other: Intervention bundle

• Registration Number: NCT03215251
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be 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.

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 Timeline

• Study Start: 2015-11
• Primary Completion: 2017-01
• Study Completion: 2017-06
• Status Verified: 2017-07
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Last Update Submitted: 2017-07-11
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EXPERIMENTAL GROUP	Intervention bundle	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.

Primary Outcome Measures

Name	Time	Method
Thirst intensity Scale	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	5 minutes	to assess dry mouth