| CTRI Number |
CTRI/2025/01/079172 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF EIGHT PILLOW TECHNIQUE V/S CONVENTIONAL TWO HOURLY POSITION CHANGE IN PATIENTS WITH PRESSURE ULCER |
|
Scientific Title of Study
|
COMPARATIVE EFFECT OF EIGHT PILLOW TECHNIQUE WITH CONVENTIONAL TWO HOURLY CHANGE OF POSITION IN PATIENTS WITH PRESSURE ULCERS: A RANDOMISED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghavendrasingh Dharwadkar |
| Designation |
Assistant professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy center, Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendrasingh Dharwadkar |
| Designation |
Assistant professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy center, Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shruti khodake |
| Designation |
Physiotherapy intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy center, Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 INDIA
Advanced physiotherapy center, Room No. 39, Sagar Floor,Dr.Prabhakar Kore Hospital and MRC. Belgaum KARNATAKA 590010 INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
8971820428 |
| Fax |
|
| Email |
shrutikhodake061@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE ACADEMY OH HIGHER EDUCATION AND RESEARCH INSTITUTE OF PHYSIOTHERAPY, NEHRU NAGAR, BELAGAVI-590010, KARNATAKA, INDIA |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar Belagavi 590010
Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shruti khodake |
KAHER Institute of Physiotherapy |
K.L.E.S Prabhakar Kore Hospital and Medical Research Center, Sagar Floor, Advance Physiotherapy Center, Neurology department, OPD No. 39, Nehru Nagar, Belgavi Belgaum KARNATAKA
Belgaum
KARNATAKA |
8971820428
Shrutikhodake061@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L899||Pressure ulcer of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
8 pillow technique |
• 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 |
| Comparator Agent |
two hourly change of position |
•The intervention would be given for 5 days.The two hourly change of position comprises of positioning a patient after every two hours making sure that the bedding is smooth. A pillow would be put between the legs if subject is lying on one side.
•Along with that a pillow support will be given on the back.
•The patients will be moved from left lateral side, supine, right lateral side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients within the age group of 18 to 75 years of all genders and willing to participate in the study
2 Willingness of responsible relatives if patient
has altered level of consciousness
3 Pressure ulcers Grade 2 or more according to
PUSH tool
|
|
| ExclusionCriteria |
| Details |
1 Diagnosed cases of unstable spinal fractures or any spinal instabilities and raised ICP which are contraindicated for movement
2 Hemodynamically unstable patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) IMITO APP: for measuring
wounds with ruler and tracing
in the clinical evaluation of
pressure ulcers.
2) Pressure ulcer scale for
healing (PUSH): to observe
and measure the pressure
ulcers. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wagner classification systems: that will allow adequately to assess & classify the stage & grade of pressure ulcers |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/02/2025 |
| 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="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
|
The study will compare the effect of eight pillow technique with conventional two hourly change of position in patients with pressure ulcers, along with repositioning patients will be given DBE, PROM of all four limbs and slow sustained stretching of muscles as per requirement. The caregivers will be explained about the technique and would be given a chart to record each time repositioning is done.
|