xml: <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/NCT06010082</url>
    </required_header>
    <id_info>
      <org_study_id>69-D</org_study_id>
      <nct_id>NCT06010082</nct_id>
    </id_info>
    <brief_title>The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women</brief_title>
    <official_title>The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women: A Randomized Control Trail</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria 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>
        There is a strong correlation between sleep disturbance and indications of stress, anxiety,&#xD;
        and depression. However, in Egypt no research has looked into how better sleep for expectant&#xD;
        mothers might be achieved by inexpensive, pleasurable, non-invasive music listening.&#xD;
        Therefore, the aim of this study was to investigate how music listening affects pregnant&#xD;
        women's psychological status, and sleep quality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study used a randomized controlled trial (RCT) design and adhered to the Consolidated&#xD;
        Standards of Reporting Trials (CONSORT) guidelines. The study utilized a simple random&#xD;
        sampling technique to select participants in proportion to the total number of pregnant women&#xD;
        in the outpatient Medical National Institute in Damanhur city, Egypt.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Actual">August 20, 2023</completion_date>
    <primary_completion_date type="Actual">July 15, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Depression, Anxiety, and Stress Scale</measure>
      <time_frame>2 months</time_frame>
      <description>The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep Quality</measure>
      <time_frame>2 months</time_frame>
      <description>It is a standardized self-report instrument used to measure the quality and patterns of sleep during the past month. It was developed and validated by Buysse et al. in 1989. It has 9 questions. Question number 5 contains 10 sub-items (from 5a to 5j). All questions are combined to form 7 components. Scoring of answers ranged from zero to three.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Pregnant Women</condition>
    <arm_group>
      <arm_group_label>STUDY GROUP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group two(the control group, 40 pregnant women):act as a control group/ waiting list</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Music Therapy</intervention_name>
      <description>Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>STUDY GROUP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In third trimester, 30-34th weeks of pregnancy, age ranging from 18-35 years old, singleton&#xD;
          pregnancy, willing to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          having any physical or mental health disorders&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Nursing, Alexandria university</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Mahmoud Khedr</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010082
  org study id: 69-D
  nct id: NCT06010082
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  There is a strong correlation between sleep disturbance and indications of stress, anxiety,
        and depression. However, in Egypt no research has looked into how better sleep for expectant
        mothers might be achieved by inexpensive, pleasurable, non-invasive music listening.
        Therefore, the aim of this study was to investigate how music listening affects pregnant
        women's psychological status, and sleep quality.
  This study used a randomized controlled trial (RCT) design and adhered to the Consolidated
        Standards of Reporting Trials (CONSORT) guidelines. The study utilized a simple random
        sampling technique to select participants in proportion to the total number of pregnant women
        in the outpatient Medical National Institute in Damanhur city, Egypt.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Depression, Anxiety, and Stress Scale
  time frame: 2 months
  description: The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.
  measure: Sleep Quality
  time frame: 2 months
  description: It is a standardized self-report instrument used to measure the quality and patterns of sleep during the past month. It was developed and validated by Buysse et al. in 1989. It has 9 questions. Question number 5 contains 10 sub-items (from 5a to 5j). All questions are combined to form 7 components. Scoring of answers ranged from zero to three.
  arm group label: STUDY GROUP
  arm group type: Experimental
  description: Intervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.
  arm group label: Control group
  arm group type: Active Comparator
  description: Group two(the control group, 40 pregnant women):act as a control group/ waiting list
  intervention type: Behavioral
  intervention name: Music Therapy
  description: Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.
  arm group label: Control group
  arm group label: STUDY GROUP
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Mahmoud Khedr
  investigator title: Lecturer
  sharing ipd: No