<?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>IRCT20181011041308N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of Mindfulness therapy on the perception of pain</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Mindfulness-Based Stress Reduction (MBSR) on the rate of depression, anxiety, stress, and the perception of low back pain after childbirth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34456</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: For randomization, random allocation rule which is a limited randomization method was used. Thus, after determining a sample size of 40 people, their names were put in a lottery vase randomly. Then, the first 20 names which were taken out randomly were dedicated to the experimental group. The remaining names were dedicated to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: This group received the mindfulness program during eight weeks, one 120-minute session each week. A brief explanation of the sessions is given as follows. First session: defining the general guideline considering the privacy and confidentiality of the private life of the people, asking people to introduce themselves to each other, training the body verification, homework, discussion and scheduling weekly meetings, distribution of notes, handouts and CDs. Second session: Training body relaxation for the 14 group of muscles including forearm, arm, calf, thighs, abdomen, chest, shoulders, neck, lips, eyes, and forehead. Third session: Training body relaxation for the 6 group of muscles including hands and arms, legs and thighs, abdomen and chest, forehead and lips, and the homework for the body relaxation. Fourth session: Introduction to the method for the breath mindfulness , training the technique of inhale and exhale with relaxation and and without thinking about other issues, training the technique for watching the breath, and the homework for the breath mindfulness before the sleep. Fifth session: Training the technique for the attention to the body movements during breath, concentration on the body parts and their movements and the search for physical senses, and homework for the eating mindfulness. Sixth session: Training to concentrate on the mind, positive and negative thoughts, pleasant and unpleasant thoughts, letting the positive and negative thoughts to enter the mind and easily moving them out of the mind without making judgment and paying deep attention to them. Seventh session: a 40-minute sitting meditation, review of the homeworks, exercising the observation of the relation between activity and the behavior. Eighth session: review of the past sessions, conclusion, and questions and answers. Intervention 2: Control group: This group did not receive the mindfulness program and they were monitored to avoid using psychological and physical treatments or pain killers during the eight weeks.</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:
Only pre-test, post-test and follow-up data are available.

When:
The time of access is 6 months after the publication of the article.

To whom:
Data is only available for academic researchers.

Conditions:
It can be submitted to the reviewers or critics of the article.
Applicants must be academic members of a university.

Where to obtain:
Islamic Azad University of Roodehen, Tehran, Dr. Narges babakhani, Address Email: babakhani@riau.ac.ir

How to obtain:
By sending an email to Dr Babakhani and then confirming it, you can receive the data and it takes less than two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Babakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roudehen, Academic Complex</address>
        <city>Roudehen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>397318898</zip>
        <telephone>+98 21 2291 5385</telephone>
        <email>babakhani@riau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Babakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roudehen, Academic Complex</address>
        <city>Roudehen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3973188981</zip>
        <telephone>+98 21 2291 5385</telephone>
        <email>babakhani@riau.ac.ir</email>
        <affiliation>Research Committee of Islamic Azad University of Roudehen</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having back pain after three months from the childbirth
Having chronic back pain due to childbirth</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having mental illness
Using other treatments related to back pain including psychological or physical
Use of pain killer medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group: This group received the mindfulness program during eight weeks, one 120-minute session each week. A brief explanation of the sessions is given as follows. First session: defining the general guideline considering the privacy and confidentiality of the private life of the people, asking people to introduce themselves to each other, training the body verification, homework, discussion and scheduling weekly meetings, distribution of notes, handouts and CDs. Second session: Training body relaxation for the 14 group of muscles including forearm, arm, calf, thighs, abdomen, chest, shoulders, neck, lips, eyes, and forehead. Third session: Training body relaxation for the 6 group of muscles including hands and arms, legs and thighs, abdomen and chest, forehead and lips, and the homework for the body relaxation. Fourth session: Introduction to the method for the breath mindfulness , training the technique of inhale and exhale with relaxation and and without thinking about other issues, training the technique for watching the breath, and the homework for the breath mindfulness before the sleep. Fifth session: Training the technique for the attention to the body movements during breath, concentration on the body parts and their movements and the search for physical senses, and homework for the eating mindfulness. Sixth session: Training to concentrate on the mind, positive and negative thoughts, pleasant and unpleasant thoughts, letting the positive and negative thoughts to enter the mind and easily moving them out of the mind without making judgment and paying deep attention to them. Seventh session: a 40-minute sitting meditation, review of the homeworks, exercising the observation of the relation between activity and the behavior. Eighth session: review of the past sessions, conclusion, and questions and answers.</i_keyword>
      <i_keyword>Control group: This group did not receive the mindfulness program and they were monitored to avoid using psychological and physical treatments or pain killers during the eight weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perception of pain. Timepoint: Before intervention, after intervention, and one month after intervention. Method of measurement: Oswestry Disability Index (ODI).</prim_outcome>
      <prim_outcome>Depression‚ Anxiety‚ Stress. Timepoint: Before intervention, after intervention, and one month after intervention. Method of measurement: Depression‚ Anxiety‚ Stress Scale (DASS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-19</approval_date>
        <contact_name>Scientific Committee on Ethics in Biomedical Research, Tehran Azad University of Medical Sciences</contact_name>
        <contact_address>Tehran-Ghods Town (West), Iran's Sims Street-Headquarters of the Ministry of Health, Medical Education and Training, Block A, Thirteenth Class Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
