<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/NCT03839147</url>
  </required_header>
  <id_info>
    <org_study_id>50687469</org_study_id>
    <nct_id>NCT03839147</nct_id>
  </id_info>
  <brief_title>The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography</brief_title>
  <official_title>The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effect of education and counseling on anxiety and pain in women&#xD;
      undergoing hysterosalpingography as part of the infertility process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fertility and having a child is a significant experience for most individuals; however, many&#xD;
      struggle to achieve pregnancy. Infertility is defined as the inability of a couple to&#xD;
      conceive after 12 months of regular unprotected sexual intercourse or to carry a pregnancy to&#xD;
      term. It is estimated that 10-15 % of the couples globally experience infertility. In Turkey,&#xD;
      it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation&#xD;
      of infertile couples, hysterosalpingography (HSG) is a simple, safe, and minimally invasive&#xD;
      radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG&#xD;
      plays an important diagnostic role in finding the cause of infertility and in deciding the&#xD;
      line of management. The aim of this study was to investigate the effect of education and&#xD;
      counseling on anxiety and pain before the treatment of women who will have HSG procedure with&#xD;
      the diagnosis of infertility.&#xD;
&#xD;
      This randomized controlled study was conducted at Gulhane Training and Research Hospital,&#xD;
      Obstetrics and Gynecology clinic between May 2016 and January 2017. Volunteer women&#xD;
      undergoing HSG as part of infertility evaluation have been included. Participants were&#xD;
      randomly assigned to the intervention or the control group using a computer-generated list. A&#xD;
      data collection form including socio-demographic and obstetric characteristics such as age,&#xD;
      educational status, duration of infertility, previous pregnancies, births, abortion/curettage&#xD;
      numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores was used for each&#xD;
      patient. After obtaining written informed consent, the data collection form, Spielberger&#xD;
      State Anxiety Scale and VAS scoring scale were applied to both groups by face to face&#xD;
      interview during the day giving appointment for HSG. Immediately after the questionnaires&#xD;
      were applied, the nurse gave individual education and counseling were giving by the nurse&#xD;
      researcher to intervention group for 30 minutes. Participants in the control group received&#xD;
      standard care (verbal information about procedure and a short written information about the&#xD;
      procedure) and no intervention (education and counseling) was performed.The IBM SPSS&#xD;
      (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the&#xD;
      data obtained in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spielberger State Anxiety Scale</measure>
    <time_frame>30 minutes</time_frame>
    <description>After completing the HSG procedure, participants filled out the Spielberger State Anxiety Scale.&#xD;
The Spielberger state anxiety scale was developed in 1964 by Spielberger. There are 20 statements in the scale that individuals can use to express their feelings. The State Scale measures the level of anxiety related to the situation and has been scored by four options for each expression. These are: &quot;None&quot; (1), &quot;Slightly&quot; (2), &quot;Many&quot; (3), &quot;Completely&quot; (4). The statements in this section are divided directly and reversed. Reversed statements are 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20.&#xD;
The total score of the expressions which are reversed from the total score of the direct expressions and adding the number 50 which is the constant value of the state anxiety scale. Spielberger and his colleagues stated that 0-19 points obtained from the scale meant &quot;no anxiety&quot;, 20-39 points meant &quot;light&quot;, 40-59 points meant &quot;medium&quot;, 60-79 points meant &quot;heavy anxiety&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale for pain intensity</measure>
    <time_frame>10 minutes</time_frame>
    <description>After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the VAS.&#xD;
A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Women's Health</condition>
  <arm_group>
    <arm_group_label>Education and Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale were applied to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. This education consisted of the definition and the purpose of hysterosalpingography, when and how it was applied, in what cases it was applied, whether it was a painful procedure, possible side effects and additional benefits of infertility treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed. Both groups were re-evaluated using the same scales after the hysterosalpingography. Within 5 minutes of completing the hysterosalpingography procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale .</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education and counseling</intervention_name>
    <description>After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered.</description>
    <arm_group_label>Education and Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being diagnosed with infertility&#xD;
&#xD;
          -  negative the result of the B-HCG testing&#xD;
&#xD;
          -  being able to understand, read and write in Turkish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not wanting to be included in the study&#xD;
&#xD;
          -  not accepting education/counseling&#xD;
&#xD;
          -  not knowing Turkish&#xD;
&#xD;
          -  having additional diseases related to pelvic pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gulten Guvenc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Sciences, Gulhane Faculty of Nursing</affiliation>
  </overall_official>
  <reference>
    <citation>Aba YA, Avci D, Guzel Y, Ozcelik SK, Gurtekin B. Effect of music therapy on the anxiety levels and pregnancy rate of women undergoing in vitro fertilization-embryo transfer: A randomized controlled trial. Appl Nurs Res. 2017 Aug;36:19-24. doi: 10.1016/j.apnr.2017.05.005. Epub 2017 May 22.</citation>
    <PMID>28720234</PMID>
  </reference>
  <reference>
    <citation>Onwuchekwa CR, Oriji VK. Hysterosalpingographic (HSG) Pattern of Infertility in Women of Reproductive Age. J Hum Reprod Sci. 2017 Jul-Sep;10(3):178-184. doi: 10.4103/jhrs.JHRS_121_16.</citation>
    <PMID>29142446</PMID>
  </reference>
  <results_reference>
    <citation>Stevenson EL, Hershberger PE, Bergh PA. Evidence-Based Care for Couples With Infertility. J Obstet Gynecol Neonatal Nurs. 2016 Jan-Feb;45(1):100-10; quiz e1-2. doi: 10.1016/j.jogn.2015.10.006. Epub 2015 Dec 1.</citation>
    <PMID>26815804</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hysterosalpingography</keyword>
  <keyword>anxiety</keyword>
  <keyword>pain</keyword>
  <keyword>education</keyword>
  <keyword>counseling</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/NCT03839147
org study id: 50687469
nct id: NCT03839147
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the effect of education and counseling on anxiety and pain in women
      undergoing hysterosalpingography as part of the infertility process.
Fertility and having a child is a significant experience for most individuals; however, many
      struggle to achieve pregnancy. Infertility is defined as the inability of a couple to
      conceive after 12 months of regular unprotected sexual intercourse or to carry a pregnancy to
      term. It is estimated that 10-15 % of the couples globally experience infertility. In Turkey,
      it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation
      of infertile couples, hysterosalpingography (HSG) is a simple, safe, and minimally invasive
      radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG
      plays an important diagnostic role in finding the cause of infertility and in deciding the
      line of management. The aim of this study was to investigate the effect of education and
      counseling on anxiety and pain before the treatment of women who will have HSG procedure with
      the diagnosis of infertility.

      This randomized controlled study was conducted at Gulhane Training and Research Hospital,
      Obstetrics and Gynecology clinic between May 2016 and January 2017. Volunteer women
      undergoing HSG as part of infertility evaluation have been included. Participants were
      randomly assigned to the intervention or the control group using a computer-generated list. A
      data collection form including socio-demographic and obstetric characteristics such as age,
      educational status, duration of infertility, previous pregnancies, births, abortion/curettage
      numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores was used for each
      patient. After obtaining written informed consent, the data collection form, Spielberger
      State Anxiety Scale and VAS scoring scale were applied to both groups by face to face
      interview during the day giving appointment for HSG. Immediately after the questionnaires
      were applied, the nurse gave individual education and counseling were giving by the nurse
      researcher to intervention group for 30 minutes. Participants in the control group received
      standard care (verbal information about procedure and a short written information about the
      procedure) and no intervention (education and counseling) was performed.The IBM SPSS
      (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the
      data obtained in the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Spielberger State Anxiety Scale
time frame: 30 minutes
description: After completing the HSG procedure, participants filled out the Spielberger State Anxiety Scale.
The Spielberger state anxiety scale was developed in 1964 by Spielberger. There are 20 statements in the scale that individuals can use to express their feelings. The State Scale measures the level of anxiety related to the situation and has been scored by four options for each expression. These are: "None" (1), "Slightly" (2), "Many" (3), "Completely" (4). The statements in this section are divided directly and reversed. Reversed statements are 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20.
The total score of the expressions which are reversed from the total score of the direct expressions and adding the number 50 which is the constant value of the state anxiety scale. Spielberger and his colleagues stated that 0-19 points obtained from the scale meant "no anxiety", 20-39 points meant "light", 40-59 points meant "medium", 60-79 points meant "heavy anxiety".
measure: Visual Analog Scale for pain intensity
time frame: 10 minutes
description: After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the VAS.
A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.
arm group label: Education and Counseling
arm group type: Experimental
description: After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale were applied to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. This education consisted of the definition and the purpose of hysterosalpingography, when and how it was applied, in what cases it was applied, whether it was a painful procedure, possible side effects and additional benefits of infertility treatment
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed. Both groups were re-evaluated using the same scales after the hysterosalpingography. Within 5 minutes of completing the hysterosalpingography procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale .
intervention type: Behavioral
intervention name: Education and counseling
description: After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered.
arm group label: Education and Counseling
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gulten Guvenc
role: Principal Investigator
affiliation: University of Health Sciences, Gulhane Faculty of Nursing
citation: Aba YA, Avci D, Guzel Y, Ozcelik SK, Gurtekin B. Effect of music therapy on the anxiety levels and pregnancy rate of women undergoing in vitro fertilization-embryo transfer: A randomized controlled trial. Appl Nurs Res. 2017 Aug;36:19-24. doi: 10.1016/j.apnr.2017.05.005. Epub 2017 May 22.
PMID: 28720234
citation: Onwuchekwa CR, Oriji VK. Hysterosalpingographic (HSG) Pattern of Infertility in Women of Reproductive Age. J Hum Reprod Sci. 2017 Jul-Sep;10(3):178-184. doi: 10.4103/jhrs.JHRS_121_16.
PMID: 29142446
citation: Stevenson EL, Hershberger PE, Bergh PA. Evidence-Based Care for Couples With Infertility. J Obstet Gynecol Neonatal Nurs. 2016 Jan-Feb;45(1):100-10; quiz e1-2. doi: 10.1016/j.jogn.2015.10.006. Epub 2015 Dec 1.
PMID: 26815804
responsible party type: Sponsor
sharing ipd: No