<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/NCT03237559</url>
  </required_header>
  <id_info>
    <org_study_id>781</org_study_id>
    <nct_id>NCT03237559</nct_id>
  </id_info>
  <brief_title>Assessment of Knowledge, Attitude and Practice of Eligible Couples Regarding Eugenics</brief_title>
  <official_title>A Descriptive Comparative Study to Assess Knowledge, Attitude and Practice Regarding Eugenics Among Eligible Couples of Selected Area of Ambala, Haryana (India)</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>
      A Descriptive study to assess the knowledge, attitude and practice regarding eugenics among&#xD;
      eligible couples of selected area of Ambala, Haryana, India. Eligible couples were the&#xD;
      married couples where wife is in the age group of 15-45 years planning for conception, have&#xD;
      conceived and may or may not have any living child.Eugenics are to methods that are adopted&#xD;
      by eligible couples for having physically and psychologically healthy conception and&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the knowledge, attitude and practice the structured knowledge questionnaire,&#xD;
      attitude 5-point likert scale and expressed checklist tool were prepared. A sample size of&#xD;
      318 was calculated by power analysis and eligible couples were selected by Purposive sampling&#xD;
      technique from rural and urban area of Ambala Haryana, India.&#xD;
&#xD;
      Each eligible couples (separately husband and wife) data was collected through Self- Report&#xD;
      technique.one time assessment only done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Structured Questionnaire</measure>
    <time_frame>15-20 min</time_frame>
    <description>It consisted of 34 knowledge items to assess the knowledge of Eligible couples regarding Eugenics. The following content areas were:&#xD;
Concept of Eugenics&#xD;
Screening of Disease&#xD;
Nutrition&#xD;
Vaccination&#xD;
Lifestyle&#xD;
Exposure to substance abuse or toxins All 34 test items were multiple choice questions. Each item had a single correct answer. Every correct answer was awarded a score of '1' and every incorrect answer was assigned a score of 00. The maximum possible score was 34 and minimum score was 00 on the structured knowledge questionnaire . Higher score indicated that eligible couples have good knowledge regarding Eugenics. Based on scoring criteria on Structured Knowledge Questionnaire, knowledge was categorized into four level of knowledge.Excellent (27-34),Good (21-26),Average (17-20),Below average(0-16)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Structured Attitude 5-point likert Scale</measure>
    <time_frame>10-15 min</time_frame>
    <description>Scale consisted of 30 items on which the respondent had to respond on 5- points Likert's scale.Each statement score was divided as strongly agree, agree, undecided, disagree, strongly disagree (maximum score was 150 and minimum score was 30).Tool had 15 positive items and 15 negative items.Positive statements were scored SA (Strongly Agree) -5, A (Agree)-4, U (Undecided)-3, D (Disagree)-2, SD (Strongly Disagree)-1. Negative statements were scored SA (Strongly Agree) -1, A (Agree)-2, U (Undecided)-3, D (Disagree)-4, SD (Strongly Disagree)-5.&#xD;
Based on scoring criteria on Structured Attitude Scale, Husbands and Wives attitude was categorized into three level of Attitude Favourable (225-300), Moderately Favourable(180-224),Unfavourable(60-179)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expressed Husband Checklist</measure>
    <time_frame>7-8min</time_frame>
    <description>Structured expressed practice checklist was developed to assess expressed practices of Husbands regarding Eugenics. Checklist consists of 18 items. These items designed to elicit information on practices of Husbands regarding Traditional and Non-traditional. Each item was provided with 2 responses Yes(Y) and No (N) and was scored as 1 and 0 respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expressed Wife Checklist</measure>
    <time_frame>10-12min</time_frame>
    <description>Structured expressed practice checklist was developed to assess expressed practices of wives regarding Eugenics. Checklist consists of 32 items. These items designed to elicit information on practices of wives regarding Traditional and Non-traditional. Each item was provided with two responses Yes(Y) and No (N) and was scored as 1 and 0 respectively</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">318</enrollment>
  <condition>Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>eligible couples</arm_group_label>
    <description>Eligible couples refers to methods that are adopted by eligible couples for having physically and psychologically healthy conception and pregnancy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible couples of rural and urban areas of Ambala Haryana, India&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  who were present at the time of data collection&#xD;
&#xD;
          -  who were willing to participate in the study&#xD;
&#xD;
          -  who can read and write English/Hindi&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who have more than 2 children&#xD;
&#xD;
          -  who had undergone permanent sterilization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Wife</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Poonam Sheoran, Ph.d Nursing</last_name>
    <role>Study Director</role>
    <affiliation>M.M.University, Mullana, Ambala Haryana, India</affiliation>
  </overall_official>
  <reference>
    <citation>Okka B, Durduran Y, Degerli Kodaz N. Traditional practices of Konya women during pregnancy, birth, the postpartumperiod, and newborn care. Turk J Med Sci. 2016 Feb 17;46(2):501-11. doi: 10.3906/sag-1504-120.</citation>
    <PMID>27511518</PMID>
  </reference>
  <reference>
    <citation>Charafeddine L, El Rafei R, Azizi S, Sinno D, Alamiddine K, Howson CP, Walani SR, Ammar W, Nassar A, Yunis K. Improving awareness of preconception health among adolescents: experience of a school-based intervention in Lebanon. BMC Public Health. 2014 Jul 31;14:774. doi: 10.1186/1471-2458-14-774.</citation>
    <PMID>25081733</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 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 2, 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>Hem Sadhanu</investigator_full_name>
    <investigator_title>Student M.Sc.Nursing</investigator_title>
  </responsible_party>
  <keyword>Eugenics</keyword>
  <keyword>Eligible Couples</keyword>
  <keyword>Knowledge</keyword>
  <keyword>Attitude</keyword>
  <keyword>Practice</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/NCT03237559
org study id: 781
nct id: NCT03237559
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A Descriptive study to assess the knowledge, attitude and practice regarding eugenics among
      eligible couples of selected area of Ambala, Haryana, India. Eligible couples were the
      married couples where wife is in the age group of 15-45 years planning for conception, have
      conceived and may or may not have any living child.Eugenics are to methods that are adopted
      by eligible couples for having physically and psychologically healthy conception and
      pregnancy.
To assess the knowledge, attitude and practice the structured knowledge questionnaire,
      attitude 5-point likert scale and expressed checklist tool were prepared. A sample size of
      318 was calculated by power analysis and eligible couples were selected by Purposive sampling
      technique from rural and urban area of Ambala Haryana, India.

      Each eligible couples (separately husband and wife) data was collected through Self- Report
      technique.one time assessment only done.
observational model: Family-Based
time perspective: Other
measure: Structured Questionnaire
time frame: 15-20 min
description: It consisted of 34 knowledge items to assess the knowledge of Eligible couples regarding Eugenics. The following content areas were:
Concept of Eugenics
Screening of Disease
Nutrition
Vaccination
Lifestyle
Exposure to substance abuse or toxins All 34 test items were multiple choice questions. Each item had a single correct answer. Every correct answer was awarded a score of '1' and every incorrect answer was assigned a score of 00. The maximum possible score was 34 and minimum score was 00 on the structured knowledge questionnaire . Higher score indicated that eligible couples have good knowledge regarding Eugenics. Based on scoring criteria on Structured Knowledge Questionnaire, knowledge was categorized into four level of knowledge.Excellent (27-34),Good (21-26),Average (17-20),Below average(0-16)
measure: Structured Attitude 5-point likert Scale
time frame: 10-15 min
description: Scale consisted of 30 items on which the respondent had to respond on 5- points Likert's scale.Each statement score was divided as strongly agree, agree, undecided, disagree, strongly disagree (maximum score was 150 and minimum score was 30).Tool had 15 positive items and 15 negative items.Positive statements were scored SA (Strongly Agree) -5, A (Agree)-4, U (Undecided)-3, D (Disagree)-2, SD (Strongly Disagree)-1. Negative statements were scored SA (Strongly Agree) -1, A (Agree)-2, U (Undecided)-3, D (Disagree)-4, SD (Strongly Disagree)-5.
Based on scoring criteria on Structured Attitude Scale, Husbands and Wives attitude was categorized into three level of Attitude Favourable (225-300), Moderately Favourable(180-224),Unfavourable(60-179)
measure: Expressed Husband Checklist
time frame: 7-8min
description: Structured expressed practice checklist was developed to assess expressed practices of Husbands regarding Eugenics. Checklist consists of 18 items. These items designed to elicit information on practices of Husbands regarding Traditional and Non-traditional. Each item was provided with 2 responses Yes(Y) and No (N) and was scored as 1 and 0 respectively.
measure: Expressed Wife Checklist
time frame: 10-12min
description: Structured expressed practice checklist was developed to assess expressed practices of wives regarding Eugenics. Checklist consists of 32 items. These items designed to elicit information on practices of wives regarding Traditional and Non-traditional. Each item was provided with two responses Yes(Y) and No (N) and was scored as 1 and 0 respectively
arm group label: eligible couples
description: Eligible couples refers to methods that are adopted by eligible couples for having physically and psychologically healthy conception and pregnancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Wife
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Poonam Sheoran, Ph.d Nursing
role: Study Director
affiliation: M.M.University, Mullana, Ambala Haryana, India
citation: Okka B, Durduran Y, Degerli Kodaz N. Traditional practices of Konya women during pregnancy, birth, the postpartumperiod, and newborn care. Turk J Med Sci. 2016 Feb 17;46(2):501-11. doi: 10.3906/sag-1504-120.
PMID: 27511518
citation: Charafeddine L, El Rafei R, Azizi S, Sinno D, Alamiddine K, Howson CP, Walani SR, Ammar W, Nassar A, Yunis K. Improving awareness of preconception health among adolescents: experience of a school-based intervention in Lebanon. BMC Public Health. 2014 Jul 31;14:774. doi: 10.1186/1471-2458-14-774.
PMID: 25081733
responsible party type: Principal Investigator
investigator affiliation: Maharishi Markendeswar University (Deemed to be University)
investigator full name: Hem Sadhanu
investigator title: Student M.Sc.Nursing
sharing ipd: No