<?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>IRCT20161213031385N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-10</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of relaxation techniques on pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study on the effect of benson and progressive muscle relaxation techniques on the severity of pain after laminectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37382</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were selected by a consecutive sampling method and randomly assigned to three groups of Benson relaxation (n=31), progressive muscle relaxation (n=31), and control (n=31).
 Dice were used to randomly assign individuals to groups.Dice number 1 and 2 were assigned for Benson relaxation group, 3 and 4 for progressive muscle relaxation and 5 and 6 for control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain after Laminectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Benson relaxation group _ In this group, patients performed the Benson relaxation technique, which is a passive relaxation technique. This relaxation procedure is done in six steps, including lie down, closing the eyes, relaxing the muscles from the bottom up (without active contraction), starting to breathe slowly, continuing to breathe slowly as the muscles relax, open Eyes slowly and away from negative thoughts. This technique was performed three times after laminectomy (2, 12 and 24 hours after consciousness). Pain intensity was measured before and 20 minutes after each relaxation by visual analogue scale (VAS). Intervention 2: Intervention group 2: Progressive muscle relaxation group _ Patients in this group performed progressive muscle relaxation techniques, which are active relaxation techniques.In this method, the individual relaxes each of his muscles (from the leg muscles to the facial muscles) by counting to 5 contractions and then counting to 10.These steps are respectively for the leg muscles, femurs, abdomen, chest, buttocks, hands and forearm, arms, shoulders, neck, forehead, tongue and jaw, eyes and face until the patient feels his whole body loosely integrated, Has been repeated. This technique was performed three times after laminectomy (2, 12 and 24 hours after consciousness). Pain intensity was measured before and 20 minutes after each relaxation by visual analogue scale (VAS). Intervention 3: Control group: Individuals in the control group received only routine treatment and they were not given any training or relaxation technique.</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:
Pain score and demographic information

When:
3 months after the completion of the study

To whom:
Researchers in Medical Sciences

Conditions:
unlimited

Where to obtain:
Send email to rezamomen88@yahoo.com

How to obtain:
The request will be sent within three weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Momen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemadzade st, Fatemi st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>rezamomen88@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Momen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemadzade st, fatemi st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>rezamomen88@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ability of learning
having reading and writing skills
being interested to do relaxation techniques
having permission from own physician</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>psychological disorders
hearing and motor disorders
addiction to opioids
those who used sleeping pills and muscle relaxant drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Benson relaxation group _ In this group, patients performed the Benson relaxation technique, which is a passive relaxation technique. This relaxation procedure is done in six steps, including lie down, closing the eyes, relaxing the muscles from the bottom up (without active contraction), starting to breathe slowly, continuing to breathe slowly as the muscles relax, open Eyes slowly and away from negative thoughts. This technique was performed three times after laminectomy (2, 12 and 24 hours after consciousness). Pain intensity was measured before and 20 minutes after each relaxation by visual analogue scale (VAS).</i_keyword>
      <i_keyword>Intervention group 2: Progressive muscle relaxation group _ Patients in this group performed progressive muscle relaxation techniques, which are active relaxation techniques.In this method, the individual relaxes each of his muscles (from the leg muscles to the facial muscles) by counting to 5 contractions and then counting to 10.These steps are respectively for the leg muscles, femurs, abdomen, chest, buttocks, hands and forearm, arms, shoulders, neck, forehead, tongue and jaw, eyes and face until the patient feels his whole body loosely integrated, Has been repeated. This technique was performed three times after laminectomy (2, 12 and 24 hours after consciousness). Pain intensity was measured before and 20 minutes after each relaxation by visual analogue scale (VAS).</i_keyword>
      <i_keyword>Control group: Individuals in the control group received only routine treatment and they were not given any training or relaxation technique</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients' pain score based on VAS scale. Timepoint: Before surgery, 2, 12 and 24 hours after consciousness. Method of measurement: Visual Analogue Scale.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-21</approval_date>
        <contact_name>Ethics committee of aja university of medical sciences</contact_name>
        <contact_address>aja university of medical sciences, Etemadzade st, Fatemi st Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
