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CTRI Number  CTRI/2024/02/062439 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Eight Pillow Technique in Prevention of Pressure Ulcers 
Scientific Title of Study   Effect of Eight Pillow Technique in Prevention of Pressure Ulcers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sachi Chikodi 
Designation  Intern 
Affiliation  KAHER Institute of Physiotherapy  
Address  KLE Prabhakar.Kore Hospital and Medical Research Center. Nehru nagar, Belagavi.
KAHER Institute of Physiotherapy, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  7892351595  
Fax    
Email  sachis062@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Raghavendrasingh Dharwadkar 
Designation  Assistant Professor 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KLE Prabhakar Kore Hospital and research centre Wards: MICU,NSICU,NMW,ICCU.
Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Raghavendrasingh Dharwadkar 
Designation  Assistant Professor 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KLE Prabhakar Kore Hospital and Research Centre. Department of Neurology Physiotherapy Room no:19
Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH 
 
Primary Sponsor  
Name  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  NEHRU NAGAR BELAGAVI 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sachi Chikodi  KLEs DR.Prabhakar Kore Hospital and Medical Research Centre  Department of Neurology Physiotherapy Room no:19 Wards:MICU,NSICU,ICCU,NMW NEHRU NAGAR BELAGAVI
Belgaum
KARNATAKA 
7892351595

sachis062@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G26||Extrapyramidal and movement disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Effect of Eight Pillow Technique in Prevention of Pressure Ulcers  Patient will be positioned on eight pillows arranged in a specific manner such that all the pressure ulcer prone areas are not in contact with the bed surface and will be repositioned every two hourly during the day and four hourly at night for 5 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  paients with high risk of pressure ulcers 
 
ExclusionCriteria 
Details  •Open wound at pressure areas such that interferes with pillow positioning.
•Conditions contraindicated for movement such as unstable spinal fractures, spinal instabilities, raised ICP.
•Hemodynamically unstable
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pressure ulcer risk assessment by BRADEN scale  1st day at recruitment and 5th day after intervention.(5 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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
Modification(s)  
N/A 
Date of First Enrollment (India)   17/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

PURPOSE

To reduce use of man power, more affordable (cost effective) and easy to administer.

Aims,

Ø  To assess the effect of the eight pillow technique as a preventive measure for reducing the risk of pressure ulcer in severe, high and moderate risk patients.

OBJECTIVES

Ø  To analyze the effect of eight pillow technique in reducing the risk of pressure                                                                                                 ulcer using BRADEN SCALE – For Predicting Pressure Sore Risk

Inclusion  Criteria:

•        Patients with age group 18 -75 years with both genders.

•        Patients willing to participate

•        Willingness of responsible relatives (if patient has altered level of consciousness)

•          Patients with <14 score on BRADEN SCALE – For Predicting Pressure Sore Risk

•         Patients unable to move in bed by themselves

 

 Exclusion  Criteria:

•        Open wound at pressure areas such that interferes with pillow positioning.

•        Conditions contraindicated for movement such as unstable spinal fractures, spinal instabilities, raised ICP.

•        Hemodynamically unstable

OUTCOME MEASURES:

·       BRADEN SCALE – For Predicting Pressure Sore Risk

 PROCEDURE

•        An ethical clearance will be obtained from KAHER Institute of Physiotherapy’s Ethical Committee before beginning the study & Clinical Trials Registry -India (CTRI) registration of the study will be done.

•        The inclusion and exclusion criteria will be used to recruit the participants.

•        Objectives of the study and instructions regarding positioning the patient on pillows will be clearly explained to the participants, relatives and care givers.

•        A written inform consent will be taken from the participants/responsible relative/caregiver (if participant presents with altered sensorium, then consent will be taken from the responsible relatives) and the procedure will be explained in their vernacular language and those consenting to participate in the study will be presented with the interventions.

•        Baseline assessment on Day 1 will be taken as per BRADEN SCALE – For Predicting Pressure Sore Risk

•        The intervention will be for 5 days.

•        The eight-pillow technique comprises of positioning the patient on eight pillows arranged in a specific manner such that all the pressure ulcer prone areas are not in contact with the bed surface i.e. 1st pillow under the head clearing the occiput of the pressure, 2nd at the upper thorax such that shoulder blades are not in contact of the surface, 3rd at lower thorax to free sacrum of pressure, similarly 4th pillow at the upper thigh and 5th under the calf relieving pressure at the knees and the heels 6th pillow supporting one upper limb as well as relieving pressure at the elbow , 7th and 8th pillow will be used for repositioning

•        Repositioning will be done as an attempt to tilt the patient in half quarter position on either side as per the repositioning schedule i.e. lifting up 2nd and 3rd pillows to insert the 7th and 8th pillow sideways thereby tilting the patient.

•        For 5 days from 8am to 8pm every second hourly repositioning is done and from 8pm to 8am every fourth hourly repositioning will be performed.

•        The caregiver is explained about the technique, given a chart to record each time he is repositioning and is made sure he is well understood.

•        The patient will then be assessed on the 5th day as per the BRADEN SCALE – For Predicting Pressure Sore Risk for results of intervention.

 


 
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