<?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>IRCT20200918048746N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Hope with Spiritual on Self-Care, quality of life, depression and biological variables in Patients diagnosed with Type II Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of Hope Therapy with Spiritual Therapy on Self-Care, quality of life, depression and biological variables in Patients diagnosed with Type II Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51017</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomized randomized clinical trial method
In order to sample and randomize the block randomization method, it is to ensure that exactly the same number of participants enter the intervention and control group at consecutive but equal intervals, in order to hide the allocation, the size of the blocks, Will be considered heterogeneous. (To select a sample after preparing a list of patients referred to Amirabad Diabetes Clinic in Tehran, contact them, select 75 people who wanted to participate in the treatment using the available sampling method, based on the inclusion criteria And were randomly assigned to three groups (hope therapy group = 25 people, spiritual therapy group = 25 people and control group = 25 people). For this purpose, participants first complete the research questionnaires, then blood tests are performed to perform tests for glycosylated hemoglobin and fasting blood sugar (fasting sugar should not exceed 135 mg / dL, hemoglobin A and C should not exceed 8%).
In other words, the invitation to participate in the study project will be distributed through a brochure and announcement at the Amirabad Diabetes Center in Tehran. After examining the entry conditions based on what was said above, they are divided into three groups of 25, because we have three study groups, we name each group with the English letters a, b, c. We write the letters a, b, c in three envelopes or on three pieces of paper and close them and mix them like lots so that it is not clear what we have written in which one. By announcing the candidacy of each person to enter the study, we randomly remove one of the envelopes and attribute the person to that group according to the letter inside it. When the second person arrives, we select one of the remaining two envelopes and assign it to that person. Then the third person will be assigned to the group written in the envelope that were not selected in the previous two selections. Work continues until the required number of samples is completed in all three groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients diagnosed with Type II Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Omid therapy in 8 sessions, Omid therapy protocol Description of sessions in Snyder Omid therapy protocol (2010) Summary of contents and activities of the first session of the pre-test, familiarization of members with the therapist and group structure, introduction of training program and purpose From the implementation of the second session, defining, explaining and expressing the characteristics of the goal, expressing the importance of being purposeful in life, explaining how hope grows and the necessity of the third session, finding hope in people, determining willpower, planning power, obstacles and goals in each person ), Help people to build their house of hope, talk about ways to achieve the goal, talk about the feelings caused by achieving the goal or failing the goal, ways to increase the chances of achieving the goal, tell the life story of the participants themselves The fourth session of raising hope in people setting promising therapeutic goals, talking about ways to increase the workforce and motivation to achieve goals, defining motivation, important areas of motivation and energy: physical energy, mental energy, talking about mental energy, storytelling Based on the components of the theory of hope and their reformulation, the fifth session continues the discussion Talking about ways to increase workforce and motivation to achieve goals, talking about physical energy as a factor in increasing willpower; Paying attention to nutrition, exercise, talking about the power of the road, preparing a list of current events and important aspects of the participants' lives and determining the importance of each of them. Sixth session. Increasing hope in people, talking about obstacles to achieving the goal, talking about self-talk. Negative as one of the obstacles, the reason for using negative self-talk, expressing strategies to change negative self-talk, setting appropriate goals according to Snyder theory and encouraging people to set goals in each area of ​​life. Seventh Session Maintaining hope in life , Talk about the importance of people in maintaining the well-being of those around them and their spouses, provide solutions to prevent them from deviating from the path to reach the goal, plan passages and appropriate solutions to achieve the set goals by turning these passages into small steps and determining successor passages. Eighth, strategies for creating and maintaining an agent, such as mental training to achieve goals and training participants to become a therapist hope and apply hopeful thinking on a daily basis, summarize sessions, get feedback from group members, and identify sessions. Follow-up and post-test. Intervention 2: Second intervention group: spiritual therapy in 8 sessions, spiritual therapy protocol in this study from the group spiritual therapy protocol proposed by Richards and Bergin (2013) including 8 psycho-spiritual components including: trust and recourse to God, prayer, thanksgiving, Patience, forgiveness and ignoring anger, communication with God and inner dialogue with God, self-awareness and listening to the inner voice, reading sacred texts and using spiritual and religious books were used (Aneshzadeh Shorideh, 1397). First, introduce the participants to each other, talk about diabetes and its physical and mental consequences, evaluate the meaning and spirituality in life, how to determine values, goals and follow them, the concept of spirituality and religion and its impact on life, ask about religion , God) we like to know where we are; Where do we come from and where do we go and where is our real home (ways to reach God and its impact on life, telling sacred stories in the Qur'an by participants, the role of worship and religious beliefs in peace, applying reciprocity through relaxation, experience Subjects relax from worship and prayer, compare their dependencies and attachment to God Vance with him, the second session of self-awareness and communication with themselves and listening to the inner voice, examining needs and goals, knowing about themselves, others and their abilities, Paying attention to your diabetes, practicing positive thoughts and avoiding negative thoughts, exploring talents, victories and successes, talking about whether there is other knowledge and spiritual power to solve the problem, completely surrendering ourselves to the supernatural (spiritual) power (absolute, Avoid the disturbing elements of peace, have faith in a higher power. The third session of awareness-raising with a conscious effort to focus attention on positive thinking with participation, meditation, calculation and retribution along with rewarding oneself and gaining insight into resolving internal conflicts. And increasing adaptation to the environment, exposing the individual to unconscious factors affecting behaviors And the search for pathological extremist mechanisms, the study of past relationships and acceptance of its role in the current behaviors of clients and its effect on the mood of the fourth session. Emphasis on accepting personal responsibility in combating obstacles and examining individual and inner traits, self-compassion and self-love. Self-satisfaction, improving interpersonal relationships and teaching ways to deal with social tensions, ways to promote satisfaction with positive interaction with the environment and achieve inner reinforcement, talking about ways to please others to achieve spiritual excellence and drawing Model of formation of this transcendence Session 5 Creating enlightenment and insight in the authorities to discover the inner and outer gifts and blessings of God that we have and rational thinking about them and achieving satisfaction and its effect on promoting self-confidence, self-reliance and self-esteem . Session 6 Learn ways to support others, empathize, love others, take care of others, do something positive for others every day, make others happy to help them grow happy, take physical, psychological, social self-care to achieve spiritual self and Discover its components and keep it alive. Session 7 Practice and talk about how to live happily and enjoy life in the present, avoid pursuing and pursuing happiness and instead be happy, express spiritual memories, how to make sense Purposefulness and happiness with the determination to leave egoism and relationship with God, the event of true happiness with the highest energy of spirituality, living in the present with joy and attention to the values ​​of life, enjoying the beauties, talking about happy moments and quietly doing the eighth session. Reviewing and summarizing the contents of the previous sessions with emphasis on looking after what we have and giving thanks and enduring problems with trust and hope in God. Subjects talk about sweet moments and memories of their lives, their experiences in problems, how to trust God in problems, close their eyes for 35 seconds and complete silence with a single chant of thanksgiving to a merciful God to reach a stage of life and thanks for abilities and Good life opportunities. Intervention 3: Control group: This group will not receive treatment until the end of the sessions and until the quarterly follow-up, but at the end and if desired, the treatments of hope and spirituality will be performed on them.</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 part of the data such as information about the main outcome or the like can be shared.

When:
Start the access period, after printing

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
In case of similar and complementary researches, the information of the present research will be available

Where to obtain:
Contact by email : peyravi.maryami@gmail.com

How to obtain:
The applicant is required to email his / her scientific research documents and after confirmation, he / she can access the information.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahmouresi Niloofar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajae Shahr , Moazzen Blvd, Islamic Azad university , Karaj Branch</address>
        <city>تهران</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3418 2301</telephone>
        <email>niloofartahmouresi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Peyravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.15, 4th Alley, Etemadzadeh St , Fatemi St</address>
        <city>تهران</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411943563</zip>
        <telephone>+98 21 8800 9020</telephone>
        <email>peyravi.maryami@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Completion and signing of informed written consent by the subject.
Age between 45-60 years.
More than a year has passed since the diagnosis of type 2 diabetes.
Hemoglobin A1C should not be more than 8%.
Fasting sugar should not exceed 135 mg / dL</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of severe physical diseases caused by diabetes such as kidney failure, vision and ..
Receiving psychological therapies during the last 3 months
Take any sedatives or neuroleptics
Increase in diabetes-related medications
abuse of drugs and psychotropic drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Omid therapy in 8 sessions, Omid therapy protocol Description of sessions in Snyder Omid therapy protocol (2010) Summary of contents and activities of the first session of the pre-test, familiarization of members with the therapist and group structure, introduction of training program and purpose From the implementation of the second session, defining, explaining and expressing the characteristics of the goal, expressing the importance of being purposeful in life, explaining how hope grows and the necessity of the third session, finding hope in people, determining willpower, planning power, obstacles and goals in each person ), Help people to build their house of hope, talk about ways to achieve the goal, talk about the feelings caused by achieving the goal or failing the goal, ways to increase the chances of achieving the goal, tell the life story of the participants themselves The fourth session of raising hope in people setting promising therapeutic goals, talking about ways to increase the workforce and motivation to achieve goals, defining motivation, important areas of motivation and energy: physical energy, mental energy, talking about mental energy, storytelling Based on the components of the theory of hope and their reformulation, the fifth session continues the discussion Talking about ways to increase workforce and motivation to achieve goals, talking about physical energy as a factor in increasing willpower; Paying attention to nutrition, exercise, talking about the power of the road, preparing a list of current events and important aspects of the participants' lives and determining the importance of each of them. Sixth session. Increasing hope in people, talking about obstacles to achieving the goal, talking about self-talk. Negative as one of the obstacles, the reason for using negative self-talk, expressing strategies to change negative self-talk, setting appropriate goals according to Snyder theory and encouraging people to set goals in each area of ​​life. Seventh Session Maintaining hope in life , Talk about the importance of people in maintaining the well-being of those around them and their spouses, provide solutions to prevent them from deviating from the path to reach the goal, plan passages and appropriate solutions to achieve the set goals by turning these passages into small steps and determining successor passages. Eighth, strategies for creating and maintaining an agent, such as mental training to achieve goals and training participants to become a therapist hope and apply hopeful thinking on a daily basis, summarize sessions, get feedback from group members, and identify sessions. Follow-up and post-test</i_keyword>
      <i_keyword>Second intervention group: spiritual therapy in 8 sessions, spiritual therapy protocol in this study from the group spiritual therapy protocol proposed by Richards and Bergin (2013) including 8 psycho-spiritual components including: trust and recourse to God, prayer, thanksgiving, Patience, forgiveness and ignoring anger, communication with God and inner dialogue with God, self-awareness and listening to the inner voice, reading sacred texts and using spiritual and religious books were used (Aneshzadeh Shorideh, 1397). First, introduce the participants to each other, talk about diabetes and its physical and mental consequences, evaluate the meaning and spirituality in life, how to determine values, goals and follow them, the concept of spirituality and religion and its impact on life, ask about religion , God) we like to know where we are; Where do we come from and where do we go and where is our real home (ways to reach God and its impact on life, telling sacred stories in the Qur'an by participants, the role of worship and religious beliefs in peace, applying reciprocity through relaxation, experience Subjects relax from worship and prayer, compare their dependencies and attachment to God Vance with him, the second session of self-awareness and communication with themselves and listening to the inner voice, examining needs and goals, knowing about themselves, others and their abilities, Paying attention to your diabetes, practicing positive thoughts and avoiding negative thoughts, exploring talents, victories and successes, talking about whether there is other knowledge and spiritual power to solve the problem, completely surrendering ourselves to the supernatural (spiritual) power (absolute, Avoid the disturbing elements of peace, have faith in a higher power. The third session of awareness-raising with a conscious effort to focus attention on positive thinking with participation, meditation, calculation and retribution along with rewarding oneself and gaining insight into resolving internal conflicts. And increasing adaptation to the environment, exposing the individual to unconscious factors affecting behaviors And the search for pathological extremist mechanisms, the study of past relationships and acceptance of its role in the current behaviors of clients and its effect on the mood of the fourth session. Emphasis on accepting personal responsibility in combating obstacles and examining individual and inner traits, self-compassion and self-love. Self-satisfaction, improving interpersonal relationships and teaching ways to deal with social tensions, ways to promote satisfaction with positive interaction with the environment and achieve inner reinforcement, talking about ways to please others to achieve spiritual excellence and drawing Model of formation of this transcendence Session 5 Creating enlightenment and insight in the authorities to discover the inner and outer gifts and blessings of God that we have and rational thinking about them and achieving satisfaction and its effect on promoting self-confidence, self-reliance and self-esteem . Session 6 Learn ways to support others, empathize, love others, take care of others, do something positive for others every day, make others happy to help them grow happy, take physical, psychological, social self-care to achieve spiritual self and Discover its components and keep it alive. Session 7 Practice and talk about how to live happily and enjoy life in the present, avoid pursuing and pursuing happiness and instead be happy, express spiritual memories, how to make sense Purposefulness and happiness with the determination to leave egoism and relationship with God, the event of true happiness with the highest energy of spirituality, living in the present with joy and attention to the values ​​of life, enjoying the beauties, talking about happy moments and quietly doing the eighth session. Reviewing and summarizing the contents of the previous sessions with emphasis on looking after what we have and giving thanks and enduring problems with trust and hope in God. Subjects talk about sweet moments and memories of their lives, their experiences in problems, how to trust God in problems, close their eyes for 35 seconds and complete silence with a single chant of thanksgiving to a merciful God to reach a stage of life and thanks for abilities and Good life opportunities.</i_keyword>
      <i_keyword>Control group: This group will not receive treatment until the end of the sessions and until the quarterly follow-up, but at the end and if desired, the treatments of hope and spirituality will be performed on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Beck Depression Over 8. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Questionnaire 13 questions Beck.</prim_outcome>
      <prim_outcome>Quality of life below 50. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Quality of Life Questionnaire SF36.</prim_outcome>
      <prim_outcome>Self care below 47. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Tobert and Glasgow Self-Care Questionnaire.</prim_outcome>
      <prim_outcome>More than 5 glycosylated hemoglobin. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Blood pressure above 140/90. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Analog blood pressure monitor.</prim_outcome>
      <prim_outcome>Fasting sugar Less than 135 mg per deciliter. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Blood Test.</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>2020-09-09</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Karaj Branch</contact_name>
        <contact_address>Rajae Shahr, Moazzen Blvd , Islamic Azad University Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
