| CTRI Number |
CTRI/2018/07/015082 [Registered on: 26/07/2018] Trial Registered Prospectively |
| Last Modified On: |
25/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [quasi experimental] |
| Study Design |
Other |
|
Public Title of Study
|
A study on effectiveness of mobile phone use on self care capacity of primigravida women attending antenatal clinic. |
|
Scientific Title of Study
|
A quasi experimental study on effectiveness of mobile phone use on self care capacity of primigravida women attending antenatal clinic, PGIMER, Chandigarh, 2017-2019. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| anshusharma856@gmail.com |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshu Sharma |
| Designation |
Msc Nursing Student |
| Affiliation |
PGIMER , Chandigarh |
| Address |
National Institute Of Nursing Education ,PGIMER ,sector 12 Chandigarh,new opd, Room no 2060
National Institute Of Nursing Education ,PGIMER ,sector 12 Chandigarh, new opd, room no 2060
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654827909 |
| Fax |
|
| Email |
anshusharma856@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avinash Kaur Rana |
| Designation |
Lecturer |
| Affiliation |
PGIMER , Chandigarh |
| Address |
National Institute Of Nursing Education ,PGIMER ,sector 12 Chandigarh
National Institute Of Nursing Education ,PGIMER ,sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872728461 |
| Fax |
|
| Email |
ranaavinash57@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anshu Sharma |
| Designation |
Msc Nursing Student |
| Affiliation |
PGIMER , Chandigarh |
| Address |
National Institute Of Nursing Education ,PGIMER ,sector 12 Chandigarh room no 2060 ,new opd
National Institute Of Nursing Education ,PGIMER ,sector 12 Chandigarh, room no 2060 ,new opd
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654827909 |
| Fax |
|
| Email |
anshusharma856@gmail.com |
|
|
Source of Monetary or Material Support
|
| Antenatal OPD,Room no 2060 ,PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Quasi experimental] |
|
|
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 |
| Anshu Sharma |
PGIMER, Chandigarh |
room no 2060 , gynae opd , PGIMER , chandigarh
Chandigarh
CHANDIGARH |
9654827909
anshusharma856@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER , Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
antenatal primigravida women, coming for regular antenatal visit ,having no high risk status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable
|
| Intervention |
uploading pdf content and messages regarding self care in primigravida women |
it includes information about minor ailments in pregnancy, self care in pregnancy, antenatal exercise, danger signals in pregnancy and their management, articles to be brought during labour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
quasi experimental study on effectiveness of mobile phone use on self care capacity of primigravida women |
|
| ExclusionCriteria |
| Details |
women not having mobile phone |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase in self care capacity, save time and money, decrease hospital visit |
after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase self care capacity of primigravida women ,save time money , decrease hospital visit |
2 month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2018 |
| Date of Study Completion (India) |
30/11/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
it is a quasi experimental study done on primigravida women attending ANC clinic PGIMER Chandigarh. Cases will be recruited from 16July 2018 from OPD. Cases include women in first, second, third trimester. First 40 consecutive cases in 3rd trimester will be recruited. They will be trained regarding self care on signs of onset on labour, warning signs, exercises, fetal moment count, articles reqired for mother and baby, hygiene , travelling , rest etc . Thereafter 40 cases of first and 40 cases of second trimester will be recruited. First and second trimester women will be adviced regarding managment of minor ailment, hygiene, clothing, diet, rest sleep, exercise etc. Researcher will be asking primigravida women about their pregnancy related health problem and self care activities. By asking them researcher will record data and give necessary advice , along with it researcher will upload content on phone of women having smart phone which will contain data related to self care . Researcher will give them her number so that they can call researcher if having any problem, necessary advice will be given and information also provided in SMS form to them. 1 follow up will be done.
|