| CTRI Number |
CTRI/2021/07/034770 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
18/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge about exercise practices among women immediately after delivery |
|
Scientific Title of Study
|
Knowledge, Attitude, Perception and Practices about exercises among women in immediate postpartum period |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Sahana |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663841205 |
| Fax |
|
| Email |
sahana.k@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhamini Krishna Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8660644145 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubha G |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9620408222 |
| Fax |
|
| Email |
shubha.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| K Sahana
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104, Udupi,Karnataka |
|
|
Primary Sponsor
|
| Name |
K Sahana |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| K Sahana |
Department of Obstetrics and Gynaecology, Kasturba Medical College, MAHE Manipal |
Department of Obstetrics and Gynaecology, Women and Children Block, Postnatal General wards 3rd Floor - WH2,WH4, WH5,
Kasturba Medical College, MAHE Manipal
Udupi
KARNATAKA |
9663841205
sahana.k@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women from coastal Karnataka in their immediate postpartum period (1 to 3 days)
Ability to read and understand either English or Kannada |
|
| ExclusionCriteria |
| Details |
Postpartum women with unstable medical conditions and Postpartum women who had intrauterine deaths |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Content validated questionnaire on Knowledge, Attitude, Perception and Practices |
Once during the duration of study of women in their immediate postpartum period (1 to 3 days)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Content validated questionnaire on Knowledge, Attitude, Perception and Practices |
Once during the duration of study of women in their immediate postpartum period (1 to 3 days) |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
Final Enrollment numbers achieved (Total)= "323"
Final Enrollment numbers achieved (India)="323" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2021 |
| Date of Study Completion (India) |
27/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional study designed to develop and content validate a questionnaire and to
explore the Knowledge, Attitude, Perception and Practices regarding exercises
in immediate postpartum period by conducting a survey using the developed
questionnaire. Although
postpartum exercises are beneficial for women to overcome their dysfunctions, it
has been observed that women are not adherent towards it even from the
immediate postpartum period. To
the best of our understanding, there is dearth of literature which has
addressed Knowledge, Attitude, Perception and Practices about exercises in the
immediate postpartum period and hence the study. The study duration is 1 year and will include 323 participants. Participants will be selected based on inclusion and exclusion criteria. Written informed consent from the participants will be obtained for administration of the questionnaire and the questionnaire will be administered to the participants. The data obtained will be analyzed.
|