<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20161126031117N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-31</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Music on self-efficacy and severity of expressed violence of women under domestic violence</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effect of music on self-efficacy and the severity of violence expressed in women under domestic violence with control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58041</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomly assign, use Random allocator software and (according to the number of 126 samples) two groups of numbers will be obtained randomly. Individuals will then be placed in intervention or control groups. For example, the numbers in group A will be women receiving the intervention and group B will be in control. Then, by referring to each of the women, we look at the table of numbers in which group they are and according to the table, they will be in the intervention or control group. This will be done for all participants. For example, the number one is in group B, which means that the first client is in the control group, Blinding description: Research participants and staff of health centers.
While explaining the work, we only ask the health staff of the centers to provide us with the contact numbers of women who have been abused if these women agree, and we do not explicitly say, for example, that Ms. X is going to be in the control group or to intervene. We will explain the work process in general. Outcomes  will be assessed by health centers' midwife that will not aware of participants' group.</study_design>
      <phase>3</phase>
      <hc_freetext>Women under domestic violence.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, they will receive 7 sessions of 45 minutes (2 sessions per week) individually according to the coronary pandemic conditions at home. Phone calls will be made twice a week and the researcher will monitor the intervention and homework. The interventions will be performed by a counseling master student in midwifery, under the direct supervision of a research team consisting of a reproductive health specialist, a doctoral nurse, and a music master. In this study, the meaning of music is non-verbal songs with the sound of nature such as wind and the sound of the sea wave and piano pieces that are uplifting and refreshing. Invigorating themes (rhythmic) rhythmic pieces with a relatively sharp melody that inspires vitality and vitality away from excitement and impatience and is accompanied by stability and calmness, which is used by Standley music therapy through Mp3 player in each The meeting will be broadcast. In the first session, a folder containing non-verbal music will be played to the participant and based on their choice, it will be used until the end of the intervention. It should be noted that all non-verbal songs in the file will have the same theme and rhythm. In this study, the first, second and third methods of stand-up music therapy will be used for the intervention group. Passive music is a joy to listen to non-verbal pieces. A special melody to create joy in patients should have a refreshing musical theme. Invigorating themes (rhythmic) rhythmic pieces with a relatively sharp melody that induces vitality and vivacity away from excitement and impatience and is accompanied by stability and calm. Active Musical Activities in Music Therapy Sessions This study will include a discussion of musical emotions, singing, and speaking along with the piano. Intervention 2: Control group: Routine care.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Research-related information is shared with the aim of keeping individuals' names and identities confidential and adhering to the 31 Code of Ethics.

When:
2022

To whom:
All researchers and research enthusiasts

Conditions:
For review and supplementary research

Where to obtain:
Author in charge of Dr. Soghar Khani

How to obtain:
She/He must first send an email to the author of the article and submit her request, and if the author and the research team deem it appropriate, the documents and files will be provided in a short time

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Soghra Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Alley, Amir Mazandarani St.,</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>481111111</zip>
        <telephone>+98 11 3336 8915</telephone>
        <email>s.khani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soghra khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Alley, Amir Mazandarani St.,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48178-57344</zip>
        <telephone>+98 11 3336 8915</telephone>
        <email>s.khani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married middle-aged and young women with experience of living with their husbands for at least a year and under domestic violence (according to the Parsa system)
Be able to read and write.
Have no habit of listening to music
No pregnancy
No chronic psychiatric disorders And major at the time of the study
No history of schizophrenia and bipolar disorder
No substance abuse
No participation in psychological intervention sessions related to domestic violence in the last 6 months
No use of antipsychotic drugs, antidepressants or mood stabilizers in Time of the study
No history of suicide attempt,
No history of hospitalization in the psychiatric ward (based on self-declaration)
Consent of the wife and her husband to participate in the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>54 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The patient's desire to leave the study
Occurrence of significant stressful events during the study (loss of a family member, job loss, bankruptcy, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, they will receive 7 sessions of 45 minutes (2 sessions per week) individually according to the coronary pandemic conditions at home. Phone calls will be made twice a week and the researcher will monitor the intervention and homework. The interventions will be performed by a counseling master student in midwifery, under the direct supervision of a research team consisting of a reproductive health specialist, a doctoral nurse, and a music master. In this study, the meaning of music is non-verbal songs with the sound of nature such as wind and the sound of the sea wave and piano pieces that are uplifting and refreshing. Invigorating themes (rhythmic) rhythmic pieces with a relatively sharp melody that inspires vitality and vitality away from excitement and impatience and is accompanied by stability and calmness, which is used by Standley music therapy through Mp3 player in each The meeting will be broadcast. In the first session, a folder containing non-verbal music will be played to the participant and based on their choice, it will be used until the end of the intervention. It should be noted that all non-verbal songs in the file will have the same theme and rhythm. In this study, the first, second and third methods of stand-up music therapy will be used for the intervention group. Passive music is a joy to listen to non-verbal pieces. A special melody to create joy in patients should have a refreshing musical theme. Invigorating themes (rhythmic) rhythmic pieces with a relatively sharp melody that induces vitality and vivacity away from excitement and impatience and is accompanied by stability and calm. Active Musical Activities in Music Therapy Sessions This study will include a discussion of musical emotions, singing, and speaking along with the piano.</i_keyword>
      <i_keyword>Control group: Routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy. Timepoint: At the time of enrollment - immediately after the intervention and one month after the intervention. Method of measurement: Schwartzer and Jurosalem General Self-Efficacy Questionnaire ( General Self- Efficacy Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The severity of the violence expressed. Timepoint: At the time of enrollment - immediately after the intervention and one month after the intervention. Method of measurement: Domestic Violence Questionnaire against Women Mohseni Tabrizi et al.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-22</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vicce chancellor for research of Mazandaran University of Medical Sciences, Moalem square sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
