| CTRI Number |
CTRI/2014/06/004649 [Registered on: 03/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study if planned pre-operative education decreases anxiety and improves satisfaction in patients undergoing surgery |
|
Scientific Title of Study
|
A study to assess whether planned pre-operative education decreases anxiety and improves satisfaction in patients undergoing surgery-A randomised controlled trial |
| Trial Acronym |
PPEDAIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VISHNU PRIYAV |
| Designation |
MEDICAL STUDENT |
| Affiliation |
MOSC MEDICAL COLLEGE |
| Address |
VAISHNAVAM
NANGIARKULANGARA P O
HARIPAD
ALAPPUZHA DISTRICT
KERALA
2011 BATCH
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA
Ernakulam
KERALA
690513
India |
| Phone |
8281330093 |
| Fax |
4843055630 |
| Email |
viki_vysh24@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANNA MATHEW |
| Designation |
PROFESSOR RESEARCH CO-ORDINATOR |
| Affiliation |
MOSC MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PHARMACOLOGY
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA
DEPARTMENT OF PHARMACOLOGY
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA
Ernakulam
KERALA
682311
India |
| Phone |
9442221950 |
| Fax |
4843055630 |
| Email |
350south@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANNA MATHEW |
| Designation |
PROFESSOR RESEARCH CO-ORDINATOR |
| Affiliation |
MOSC MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PHARMACOLOGY
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA
DEPARTMENT OF PHARMACOLOGY
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA
Ernakulam
KERALA
682311
India |
| Phone |
9442221950 |
| Fax |
4843055630 |
| Email |
350south@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR STS
ID NO 2014-01169 |
|
|
Primary Sponsor
|
| Name |
MOSC MEDICAL COLLEGE |
| Address |
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrMIRIAM GEORGE FENN |
MOSC MEDICAL COLLEGE |
DEPARTMENT OF GYNAECOLOGY P3 WARD
MOSC MEDICAL COLLEGE
KOLENCHERY KOCHI
ERNAKULAM DISTRICT
KERALA
Ernakulam
KERALA |
9605736622
4843055630
kirthanajacob@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MOSC MEDICALCOLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HOSPITALISED PATIENTS UNDERGOING FIBROID SURGERY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO PLANNED PRE-OPERATIVE EDUCATION |
NO PLANED PRE-OPERATIVE EDUCATION IS GIVEN TO PATIENTS ON THE DAY BEFORE UNDERGOING FIBROID SURGERY |
| Intervention |
PLANNED PRE-OPERATIVE EDUCATION |
PLANNED PRE-OPERATIVE EDUCATION IS GIVEN TO PATIENTS ON THE DAY BEFORE UNDERGOING FIBROID SURGERY |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
WOMEN ADMITTED FOR FIBROID SURGERY IN A PRIVATE MEDICAL COLLEGE |
|
| ExclusionCriteria |
| Details |
ALL MEDICAL PROFESSIONALS ADMITTED FOR FIBROID SURGERY |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ANXIETY MEASURED USING AMSTERDAM PRE-OPERATIVE ANXIETY INFORMATION SCALE(APAIS) |
ANXIETY MEASURED PRE-OPERATIVELY ON DAY BEFORE SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PATIENT SATISFACTION ASSESSED BY PATIENT SATISFACTION QUESTIONNAIRE SHORT FORM-18(PSQ-18) |
PATIENT SATISFACTION ASSESSED ON THE SECOND DAY AFTER SURGERY. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
08/05/2014 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study in patients undergoing fibroid surgery we hope to assess whether planned pre-operative education using principles of effective communication relieves anxiety and improves patient satisfaction.All patients in the age group 30-55 years, admitted for fibroid surgery in the gynaecology ward of this Medical College who have already received counselling from the treating physician, will be eligible to participate in the study .Patients who give written informed consent and fulfill the inclusion criteria will be randomised by permuted block randomisation to two groups -Group X and Group Y. Planned pre-operative education (PPE) standardised to include information regarding surgery,assurance regarding competence of doctors will be given to patients in Group X while Group Y will not receive PPE. The Amsterdam Pre-operative Anxiety and Information Scale (APAIS) has been shown to be a valid, reliable and easily applicable instrument for assessing the patient’s pre-operative anxiety and need for information. Anxiety will be assessed using APAIS by the investigator on admission and demographic data will be collected.PPE will be administered to Group X. A blinded assessor will assess anxiety on the day prior to surgery. Patient Satisfaction Questionnaire Short form(PSQ-18) is a concise validated tool that can be applied to various settings.Patient satisfaction will be assessed by the investigator using this tool prior to discharge.
|