<?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>IRCT20221108056445N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-07</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of Benson's relaxation and mindfulness on the sleep quality of pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Benson's relaxation and mindfulness on the sleep quality of pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66765</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block random assignment will be done in such a way that according to the number of study groups (three groups) consisting of intervention 1 (mindfulness), intervention 2 (Benson's relaxation) and control and calculated based on the factorial law, i.e. 3!= 3×2×1= 6, all the possible arrangement modes of people will be compiled based on the table below, considering A for intervention group 1 (Benson's relaxation), B for intervention group 2 (mindfulness) and C for control group:
  1       2      3      4      5       6
CBA CAB BCA BAC ACB ABC
Then, since the estimated sample size was 120 people, in each block, three samples, each representative of a study group and their arrangement order was also different, from these blocks, placement sampling will be done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Normal pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Benson relaxation: At first, the Benson relaxation method will be taught to the participants in a 60-minute session in groups of 5 to 10 people. Then the interventions will be carried out according to the protocol, during 8 weeks and 1 day a week. Then there will be a telephone follow-up to inform about the exercises at home. Intervention 2: Intervention group 2: Mindfulness: People will be divided into groups of 5 to 10 people. The intervention includes; 8 sessions, the duration of each session is 1 hour and 1 session per week, for a total of 8 weeks, according to the protocol, will be conducted as follows: First session: 1. Introduction of the participants and a brief description of the 8 sessions 2. Eating technique Raisins and then meditate for 30 minutes, scan the body and talk about the feelings caused by doing these meditations. Second session: 1. Body scan and discussion about this experience 2. Doing sitting meditation. The third session: 1. Practicing seeing and focusing on emotions 2. Paying attention to the practice at the moment of doing it, paying attention to breathing and paying attention to the body 3. Three-minute practice of the breathing space. The fourth session: 1. Meditation with attention to breathing 2. Practicing speaking and listening to your feelings. The fifth session: 1. Doing meditation 2. Practicing accepting yourself and your feelings. Sixth session: 1. Practicing breathing space 2. Practicing not judging feelings and events. Seventh session: Meditation and awareness of everything that comes into consciousness at the moment. Eighth session: review of experiences and post-test implementation. Intervention 3: Control group: non-intervention: this training group will not be given.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd floor, No. 97, The second sub-right side, 2nd alley, Shahidan Sasani St., Tondgoyan Blvd., Shiraz, Fars, Islamic Republic of Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7168878831</zip>
        <telephone>+98 71 3739 5421</telephone>
        <email>faattii.shams63@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadlatif Rastian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Zeinab College of Nursing, Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital, Yasuj, Kohgiloyeh and Boyerahmad, Islamic Republic of Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7168878831</zip>
        <telephone>+98 74 3323 4115</telephone>
        <email>r115_rastian@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to communicate and answer questions from patients or patients
Being 18-35 years old
Consent to participate in the study and sign the informed consent form
Having a gestational age of 28-36 weeks (last 3 months of pregnancy) (according to LMP or ultrasound)
Being belly first
monogamy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not wanting to continue participating in the study
Previous participation in studies similar to the current research
Lack of inclusion criteria
Suffering from a chronic disease such as: heart disease and diabetes and needing medicine or special care
Suffering from mental illnesses such as depression during the last year
Use of neuropsychiatric drugs and addiction to drugs and cigarettes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>z34.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>supervision of other normal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Benson relaxation: At first, the Benson relaxation method will be taught to the participants in a 60-minute session in groups of 5 to 10 people. Then the interventions will be carried out according to the protocol, during 8 weeks and 1 day a week. Then there will be a telephone follow-up to inform about the exercises at home.</i_keyword>
      <i_keyword>Intervention group 2: Mindfulness: People will be divided into groups of 5 to 10 people. The intervention includes; 8 sessions, the duration of each session is 1 hour and 1 session per week, for a total of 8 weeks, according to the protocol, will be conducted as follows: First session: 1. Introduction of the participants and a brief description of the 8 sessions 2. Eating technique Raisins and then meditate for 30 minutes, scan the body and talk about the feelings caused by doing these meditations. Second session: 1. Body scan and discussion about this experience 2. Doing sitting meditation. The third session: 1. Practicing seeing and focusing on emotions 2. Paying attention to the practice at the moment of doing it, paying attention to breathing and paying attention to the body 3. Three-minute practice of the breathing space. The fourth session: 1. Meditation with attention to breathing 2. Practicing speaking and listening to your feelings. The fifth session: 1. Doing meditation 2. Practicing accepting yourself and your feelings. Sixth session: 1. Practicing breathing space 2. Practicing not judging feelings and events. Seventh session: Meditation and awareness of everything that comes into consciousness at the moment. Eighth session: review of experiences and post-test implementation.</i_keyword>
      <i_keyword>Control group: non-intervention: this training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: The amount of sleep quality of pregnant women at the beginning of the study (before the start of the intervention) and immediately after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-08</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
