<?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>IRCT20180528039882N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-08</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of Benson Relaxation  and Foot Reflexology on the Quality of Sleep in Patients with Heart Failure</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Benson Relaxation  and Foot Reflexology on the Quality of Sleep in Patients with Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31522</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random random allocation ,method using balanced block randomization (BBR) ,with 6-point permutational blocks to 2 test groups and 1 control group, Blinding description: People who are invited to participate in the study and are classified in intervention groups after being informed consentfully are not aware of the allocation of study groups. Patients are not referred to the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with systolic heart failure (mild to moderate).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, foot-reflecting massage is performed as a non-invasive intervention by hand after preparing the legs, and then the foot-foot reflection massage is done in the foot area at the point of the pinnacle at sixty feet. Before performing the back massage, the palms of the foot in the area At first, a minute of general massage of the foot is performed with the same precursor movements to warm the feet in the patient, and then the foot reflexology of the foot with direct thumb on the respective area of each foot for 15 minutes and a total of 30 minutes. The intervention is conducted 3 times a week for 4 weeks at the clinic by a researcher and researcher. Intervention 2: Intervention group: Relaxation exercises are individually taught to the research units. Subsequently, the instruction manual accompanies a compact disc recorded by the training process or via mobile Bluetooth for home-based training to research units They were asked to perform the exercises for 2 days, for the first time in the morning (between 8-10 o'clock) and 2 o'clock in the evening (between 20 o'clock to 22 o'clock) for 20 minutes for 4 weeks. Intervention 3: Control group: 3. A control group that only undergoes routine treatment.</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:
Part of the data, such as information on the main outcome, is shared best practice.

When:
Start the access period 6 months after printing the results

To whom:
researchers

Conditions:
For research on the topic of study

Where to obtain:
Gonabad University of Medical Sciences

How to obtain:
Refer to the publisher site

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Massoomeh Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.19;Modarress 24 Street;45Meters Avenue;Torbat Heidari</address>
        <city>Torbat Heidari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9519656563</zip>
        <telephone>+98 51 5223 6418</telephone>
        <email>emami.m@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Massoomeh Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.19;Modarress 24 Street;45Meters Avenue;Torbat Heidari</address>
        <city>Torbat Heidari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9519656563</zip>
        <telephone>+98 51 5223 6418</telephone>
        <email>emami.m@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
Having at least 30 years and maximum 60 years of age
No admission to psychiatric wards and no known psychiatric disorders (schizophrenia, anxiety, depression, dementia).
Not having chronic disease (cancer, musculoskeletal disorders, chronic renal failure)
Have full vigilance and acceptable listening and speaking ability to answer questions and learn the relaxation method.
Do not take sedative drugs such as benzodiazepines
Having no history of injury, open wounds, and surgery in the legs during the last two years that prevent the massage of the back of the foot. Considering the history, the medical records and the researcher's observation
Confirmation of diagnosis of systolic (mild to moderate) heart failure by a specialist who has been ill for at least six months
Confirmation of undesirable sleep quality based on Peters Leaf questionnaire (score 5-21 is recognized as undesirable sleep quality)
10. The patient is completely alert and able to answer questions.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the patient is unsatisfied, continue to participate in the study
Patient's death
The occurrence of any unexpected complications during an intervention that prevents the patient from continuing work (arrhythmia, CPR on the patient during an intervention, secondary myocardial infarction, or angioplasty).
People with a history of diabetic neuropathy.
Phase compensated heart failure entered the unconsolidated phase.
Do not have a history of missing loved ones in the past two months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, foot-reflecting massage is performed as a non-invasive intervention by hand after preparing the legs, and then the foot-foot reflection massage is done in the foot area at the point of the pinnacle at sixty feet. Before performing the back massage, the palms of the foot in the area At first, a minute of general massage of the foot is performed with the same precursor movements to warm the feet in the patient, and then the foot reflexology of the foot with direct thumb on the respective area of each foot for 15 minutes and a total of 30 minutes. The intervention is conducted 3 times a week for 4 weeks at the clinic by a researcher and researcher</i_keyword>
      <i_keyword>Intervention group: Relaxation exercises are individually taught to the research units. Subsequently, the instruction manual accompanies a compact disc recorded by the training process or via mobile Bluetooth for home-based training to research units They were asked to perform the exercises for 2 days, for the first time in the morning (between 8-10 o'clock) and 2 o'clock in the evening (between 20 o'clock to 22 o'clock) for 20 minutes for 4 weeks</i_keyword>
      <i_keyword>Control group: 3. A control group that only undergoes routine treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve sleep quality based on Peters Leaf questionnaire. Timepoint: Sleep quality measurement before intervention and after intervention, duration of intervention is 3 weeks. Method of measurement: Petersberg Questionnaire.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-21</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Khorasan Razavi province, Gonabad city, Asian road border Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
