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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 22:06:47 GMT) CTRI Number CTRI/2020/03/024289 [Registered on: 26/03/2020] - Trial Registered Prospectively Last Modified On 18/03/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Other (Specify) [Health Education intervention] Study Design Other Public Title of Study Mobile based Appliction on "Pregnancy Care" Scientific Title of Develop and Evaluate the effectiveness of Mobile Application on “Pregnancy Care” in terms of Study Awareness, Expressed practices and Anxiety among Primigravida Mothers attending Antenatal OPD of Selected Hospitals of Northern India. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Manpriya Kaur Trial Coordinator (multi-center study) Designation Research scholar Affiliation Maharishi Markandeshwar deemed to be university Address MM College of Nursing, Mullana Ambala Haryana 133207 India Ambala HARYANA 133207 India Phone 8054437496 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Poonam Sheoran Query) Designation Professor Affiliation Maharishi Markandeshwar deemed to be university Address MM College of Nursing, Mullana Ambala Haryana 133207 India Ambala HARYANA 133207 India Phone 8059930267 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Manpriya Kaur Designation Research scholar Affiliation Maharishi Markandeshwar deemed to be university Address MM College of Nursing, Mullana Ambala Haryana 133207 India Ambala HARYANA 133207 India Phone 8054437496 Fax Email [email protected] page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Source of Monetary or Source of Monetary or Material Support Material Support > Maharishi Markandeshwar Institute of Medical Sciences and Research. Primary Sponsor Primary Sponsor Details Name Maharishi Markandeshwar deemed to be University Address Mullana, Ambala Distt, Haryana, 133207 Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Manpriya Kaur Antenatal OPD of MMDU,Mullana,Ambala 8054437496 selected hospitals of distt, Haryana, 133207, Northern India Ambala, Haryana manpriya.grewal@gmai Ambala l.com HARYANA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IEC Approved 19/07/2019 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Primigravida mothers attending first antenatal visit Intervention / Type Name Details Comparator Agent Intervention Mobile application based Mobile application on antenatal education "Pregnancy Care" used by the primigravida mothers will be prepared in local language that includes health education components such as antenatal check-up,minor ailments in pregnancy, diet in pregnancy, birthing process and breastfeeding. This package will be delivered in an excluded room which is located near OPD without any other individual being present. Utilization and acceptability of the Mobile App will be assessed through google analytics and telephonic survey. Comparator Agent Routine antenatal care Routine antenatal care as given in the study hospital Inclusion Criteria Inclusion Criteria Age From 19.00 Year(s) Age To 35.00 Year(s) Gender Female Details Primigravida mothers:<br/> 1. willing to participate in the study and give informed consent.<br/> 2. attending antenatal OPD and who will page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in be available during the data collection period<br/> 3.can speak and read Hindi/English<br/> 4.having android mobile phone.<br/> 5.Daily user of smart phone.<br/> <br/> Exclusion Criteria Exclusion Criteria Details Primigravida mothers :- 1.having any visual/hearing /mental disability. 2.having miscarriage during recruitment process. 3.with pregnancy complication. 4.who develop any complication during the period of study will be excluded. Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints 1.Improvement in awareness among at time of recruitment,at 20 wks, at 26 wks, at 30 Primigravida mothers regarding pregnancy care. wks, at 34 wks 2. Improvement in expressed practices regarding pregnancy care by Primigravida mothers. 3. Prevalence of pregnancy specific anxiety. Secondary Outcome Outcome Timepoints 1.Ease of availability of health information on at time of recruitment,at 20 wks, at 26 wks, at 30 pregnancy care through Android based wks, at 34 wks application. 2.Increase in satisfaction and reduce number of hospital visits for minor ailments. Target Sample Size Total Sample Size=540 Sample Size from India=540 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 01/08/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=7 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil Brief Summary App based approach is one of the strategy to educate the primigravida mothers on different aspects of antenatal care such as antenatal advices, exercises, about diet in pregnancy, minor ailments of pregnancy, birthing process and breastfeeding. If the application is provided in their local language then it will be easy for the antenatal mother to understand various aspects of antenatal care. Currently the number of women accessing the complete antenatal care package (to monitor the fetal development and to know about maternal page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in well-being) is quite low which results in delay in reaching the health facility and ultimately increases the risk of complications to both mother and baby. To fulfil the needs of the pregnant mothers, credible applications related to pregnancy, birth and child care should be developed in local language and managed by qualified health professionals, so that there will be quick provision of credible professional information for the pregnant mothers. Policy experts should consider merging m-health programs in the national health agendas to achieve SDG goals and targets and reduce maternal and newborn mortality and morbidity rates. In India, m-Health is still in seedling stage and hence more studies are required to prove its role in delivering maternal and new born health care. STATEMENT OF THE PROBLEM A study to develop and evaluate the effectiveness of Mobile Application on “Pregnancy Care” in terms of awareness, expressed practices and pregnancy specific anxiety among primigravida mothers attending antenatal OPD of selected hospitals of Northern India. OBJECTIVES OF THE STUDY The study will be conducted based on following objectives- 1. To develop and validate the Mobile Application on “Pregnancy Care” 2. To assess and compare the post-test scores of awareness regarding antenatal care among primigravida mothers in experimental and comparison group. 3. To assess and compare the post-test scores of expressed practices regarding antenatal care among primigravida mothers in experimental and comparison group. 4. To assess and compare the post-test scores of pregnancy specific anxiety among primigravida mothers in experimental and comparison group 5. To determine the correlation between awareness, expressed practices and pregnancy specific anxiety among primigravida mothers. 6. To find the association of awareness and expressed practices with the page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in selected socio-demographic variables. 7. To ascertain the accessibility and usability of the Mobile Application on “Pregnancy Care” by the primigravida mothers. 8. To determine the opinion of primigravida mothers on acceptability of the Mobile Application on “Pregnancy Care”. page 5 / 5 Powered by TCPDF (www.tcpdf.org).
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