<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03239548</url>
  </required_header>
  <id_info>
    <org_study_id>100076</org_study_id>
    <nct_id>NCT03239548</nct_id>
  </id_info>
  <brief_title>&quot;Opinion of Doctors,Nurses and Key Informants About Independent Nurse Midwifery Practitioner in Northern India</brief_title>
  <acronym>INMP</acronym>
  <official_title>&quot;A Study to Assess the Opinion of Doctors, Nurses and Key Informants Regarding Independent Nurse Midwifery Practitioner at Selected Hospitals and Colleges of Nursing in Haryana.&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maharishi Markendeswar University (Deemed to be University)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maharishi Markendeswar University (Deemed to be University)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;A Study to assess the Opinion of Doctors, Nurses and Key informants regarding Independent&#xD;
      Nurse Midwifery Practitioner at selected Hospitals and Colleges of nursing in Haryana.&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstact Introduction: Despite improvement in coverage of institutional deliveries and skilled&#xD;
      birth attendants, India has missed its Millennium Development Goal to reduce maternal&#xD;
      mortality rate. In order to increase access to primary care services, the Independent Nurse&#xD;
      Practitioner (INP) is one of the best solutions.&#xD;
&#xD;
      Objectives: The objectives of the study were to assess the opinion of doctors, nurses and key&#xD;
      informants regarding Independent Nurse Midwifery Practitioner (INMP) and to determine the&#xD;
      association of opinion score of doctors, nurses and key informants with their selected&#xD;
      demographic variables.&#xD;
&#xD;
      Material and Methods: A Quantitative Non Experimental Research Approach and Descriptive&#xD;
      Survey Design was adopted. A total of 400 subjects (120 doctors, 120 nurses and 160 key&#xD;
      informants) were selected using purposive sampling technique from selected hospitals and&#xD;
      nursing colleges of Ambala, Panchkula and Yamunanagar districts of Haryana. The tool used for&#xD;
      the study consisted of structured performa regarding sample characteristics and likert scale.&#xD;
      Research tool was submitted to 11 experts from various departments for validity. Reliability&#xD;
      was calculated by Cronbach's alpha and it was 0.75 for likert scale. Data Collection was done&#xD;
      from December 2016 to February 2017. The obtained data was analyzed and interpreted in terms&#xD;
      of objectives and research hypothesis. Descriptive and inferential statistics were used to&#xD;
      analyze the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Likert scale</measure>
    <time_frame>12-15 Minutes</time_frame>
    <description>A Structured likert scale was developed to assess the opinion of doctors, nurses and key informants regarding Independent Nurse Midwifery Practitioner. Likert scale consisted of 26 items prepared to assess the opinion of doctors , nurses and key informants regarding Independent Nurse, Midwifery Practitioner.&#xD;
It consists of 13 positive items and 13 negative items.The respondent was required to give their opinion on likert's five point scale from strongly agree, agree, undecided, disagree and strongly disagree. The responses were quantified by giving scores. Every positive statement was scored as:Strongly agree - 5, Agree - 4, Undecided - 3, Disagree - 2 and Strongly disagree - 1. And every negative statement was scored as:Strongly agree - 1, Agree - 2, Undecided - 3, Disagree - 4 and Strongly disagree - 5. The maximum score was 130 and minimum score was 26. It consists score of 98 -130 (Favourable), 65 - 97 (Moderately favorable) and 26 - 64 (Unfavouable)</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Opinion</condition>
  <arm_group>
    <arm_group_label>Doctor</arm_group_label>
    <description>It refers to the doctors with minimum qualification as M.B.B.S and B.A.M.S; working on various posts in the clinical areas of all the departments of selected hospitals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nurses</arm_group_label>
    <description>It refers to the Registered Nurses working on various posts in the clinical areas of all the departments of selected hospitals and Principals, Vice Principals of selected colleges.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Key informants</arm_group_label>
    <description>It refers to the general public including patients admitted and attending O.P.D and their attendants with minimum qualification as graduation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Doctors, nurses and key informants in selected hospitals and colleges of Panchkula, Ambala&#xD;
        and Yamunanagar districts of Haryana and available during data collection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Doctors, nurses and key informants who were&#xD;
&#xD;
               -  available at the time of data collection in study setting.&#xD;
&#xD;
               -  willing to participate in the study.&#xD;
&#xD;
               -  able to read and write Hindi or English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Key informants who were not having minimum qualification as graduation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poonam Sheoran, Ph.D Nursing</last_name>
    <role>Study Director</role>
    <affiliation>Maharishi Markandeshwar University</affiliation>
  </overall_official>
  <reference>
    <citation>Stoll KH, Hauck YL, Hall WA. Home or hospital? Midwife or physician? Preferences for maternity care provider and place of birth among Western Australian students. Women Birth. 2016 Feb;29(1):e33-8. doi: 10.1016/j.wombi.2015.07.187. Epub 2015 Aug 28.</citation>
    <PMID>26319505</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maharishi Markendeswar University (Deemed to be University)</investigator_affiliation>
    <investigator_full_name>Shikha Guleria</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Opinion,</keyword>
  <keyword>Doctors,</keyword>
  <keyword>Nurses,</keyword>
  <keyword>Key informants,</keyword>
  <keyword>Independent Nurse Midwifery Practitioner</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239548
org study id: 100076
nct id: NCT03239548
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
"A Study to assess the Opinion of Doctors, Nurses and Key informants regarding Independent
      Nurse Midwifery Practitioner at selected Hospitals and Colleges of nursing in Haryana."
Abstact Introduction: Despite improvement in coverage of institutional deliveries and skilled
      birth attendants, India has missed its Millennium Development Goal to reduce maternal
      mortality rate. In order to increase access to primary care services, the Independent Nurse
      Practitioner (INP) is one of the best solutions.

      Objectives: The objectives of the study were to assess the opinion of doctors, nurses and key
      informants regarding Independent Nurse Midwifery Practitioner (INMP) and to determine the
      association of opinion score of doctors, nurses and key informants with their selected
      demographic variables.

      Material and Methods: A Quantitative Non Experimental Research Approach and Descriptive
      Survey Design was adopted. A total of 400 subjects (120 doctors, 120 nurses and 160 key
      informants) were selected using purposive sampling technique from selected hospitals and
      nursing colleges of Ambala, Panchkula and Yamunanagar districts of Haryana. The tool used for
      the study consisted of structured performa regarding sample characteristics and likert scale.
      Research tool was submitted to 11 experts from various departments for validity. Reliability
      was calculated by Cronbach's alpha and it was 0.75 for likert scale. Data Collection was done
      from December 2016 to February 2017. The obtained data was analyzed and interpreted in terms
      of objectives and research hypothesis. Descriptive and inferential statistics were used to
      analyze the data.
observational model: Other
time perspective: Other
measure: Likert scale
time frame: 12-15 Minutes
description: A Structured likert scale was developed to assess the opinion of doctors, nurses and key informants regarding Independent Nurse Midwifery Practitioner. Likert scale consisted of 26 items prepared to assess the opinion of doctors , nurses and key informants regarding Independent Nurse, Midwifery Practitioner.
It consists of 13 positive items and 13 negative items.The respondent was required to give their opinion on likert's five point scale from strongly agree, agree, undecided, disagree and strongly disagree. The responses were quantified by giving scores. Every positive statement was scored as:Strongly agree - 5, Agree - 4, Undecided - 3, Disagree - 2 and Strongly disagree - 1. And every negative statement was scored as:Strongly agree - 1, Agree - 2, Undecided - 3, Disagree - 4 and Strongly disagree - 5. The maximum score was 130 and minimum score was 26. It consists score of 98 -130 (Favourable), 65 - 97 (Moderately favorable) and 26 - 64 (Unfavouable)
arm group label: Doctor
description: It refers to the doctors with minimum qualification as M.B.B.S and B.A.M.S; working on various posts in the clinical areas of all the departments of selected hospitals.
arm group label: Nurses
description: It refers to the Registered Nurses working on various posts in the clinical areas of all the departments of selected hospitals and Principals, Vice Principals of selected colleges.
arm group label: Key informants
description: It refers to the general public including patients admitted and attending O.P.D and their attendants with minimum qualification as graduation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Poonam Sheoran, Ph.D Nursing
role: Study Director
affiliation: Maharishi Markandeshwar University
citation: Stoll KH, Hauck YL, Hall WA. Home or hospital? Midwife or physician? Preferences for maternity care provider and place of birth among Western Australian students. Women Birth. 2016 Feb;29(1):e33-8. doi: 10.1016/j.wombi.2015.07.187. Epub 2015 Aug 28.
PMID: 26319505
responsible party type: Principal Investigator
investigator affiliation: Maharishi Markendeswar University (Deemed to be University)
investigator full name: Shikha Guleria
investigator title: Principal Investigator
sharing ipd: No