| CTRI Number |
CTRI/2021/03/032030 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
23/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [using noise canceeling headphones in ICU patients] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of anxiety using faces anxiety scale in ICU patients using noise ablating headphones during night time versus ICU patients receiving usual care |
|
Scientific Title of Study
|
Evaluation of anxiety using faces anxiety scale in ICU patients using noise ablating headphones during night time versus ICU patients receiving usual care. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROUBLE JALOTA |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology,
King George Medical University,
Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9646057694 |
| Fax |
|
| Email |
roublejalotta7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Parvez Khan |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology,
King George Medical University, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839070724 |
| Fax |
|
| Email |
mpk_786@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Parvez Khan |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology,
King George Medical University, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839070724 |
| Fax |
|
| Email |
mpk_786@yahoo.com |
|
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Source of Monetary or Material Support
|
| King George Medical University |
|
|
Primary Sponsor
|
| Name |
Rouble Jalota |
| Address |
Department of Anaesthesiology,
King George Medical University, Lucknow. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rouble Jalota |
King George Medical University,Lucknow. |
Department of Anaesthesiology, KGMU, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH |
9646057694
roublejalotta7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: ICU patients, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To evaluate whether reduction of stressful ICU noise during night time has some effect on patient’s anxiety levels over the course of their stay in ICU |
This study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups.
1) receiving usual care ( control group)
2) Standard nose ablating headphones applied from 11pm to 6am nightly for seven nights or until ICU discharge. |
|
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Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Eligible patients are any patients in ICU who could interact even intermittently in order to respond to questions about their feelings and emotions , opened their eyes in response to hearing their name or spontaneously or are awake , understand Hindi and have sufficient corrected vision to see Faces scale.
These patients must be admitted in ICU for atleast 48 hours. |
|
| ExclusionCriteria |
| Details |
Patients having:
a)severe to profound hearing loss.
b)head or oromaxillofacial trauma.
c)Baseline use of hearing aids.
d)any other contradiction to use of ear plugs or headphones.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups.
receiving usual care ( control group)
Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge.
In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale.
Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
|
Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups.
receiving usual care ( control group)
Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge.
In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale.
Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Secondary: Effect on the requirement of sedatives in ICU during the course of their stay.
|
Secondary: Effect on the requirement of sedatives in ICU during the course of their stay.This will be viewed for atleast for days of their ICU stay that whether the requirement of sedatives increase or decrease on putting noise ablating headphones during night time. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The Intensive care Unit is one of the most stressful environments for people among various clinical settings in hospital. ICU patients are not only compromised by illness but are also faced wide variety of stressors such as experience of pain, unfamiliar environment, insomnia, fear, threat of death and loss of interaction with family members and friends. Increased Stress activate sympathetic nervous system manifested by increased heart rate, blood pressure and respiratory rate. ICU environment in itself is one of the major causes of anxiety in patients which further increases their stay there. To evaluate the anxiety we are using Faces Anxiety Scale which is considered as valid measure of anxiety( the study from American journel of Critical Care). Aim: To evaluate whether reduction of stressful ICU noise during night time has some effect on patient’s anxiety levels over the course of their stay in ICU using nose ablating headphones.
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