<?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>IRCT20180404039194N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-19</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effect of gentle stretching exercises and foot reflexology massage on the pain of patients after spinal surgery</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of gentle stretching exercises and foot reflexology massage on the pain of patients after spinal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Assigned with random spss numbers, in intervention or control groups,randomly, Blinding description: Patients who have spinal surgery have undergone surgery or intervention according to entry criteria and randomly in the control group or intervention group 1 or 2. Patients in each group are unaware of being in the intervention or control group. However, in each group patients are told about routine or intervention (reflexology or stretching exercises) and they will intervene in case of written consent.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Severity of pain after surgery of the thoracic sphincter and lumbar spine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The intervention is performed as a reflexology massage on the sole of the palm, with the thumb, on the inner curvature of the floor of both legs, the alternating to the wave and smoke, and in the reciprocation of about 10 -7 minutes per foot. This intervention is performed at least once a day, 3 times a week and for 6 weeks. Intervention 2: Intervention group: . Intervention 3: Control group: .</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:
The effect of mild stretching exercises and foot reflexology massage on the severity of pain in the lower and lower extremities in patients undergoing thoracic and lumbar spine surgery. The results of this research are shared among other researchers in this regard.

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

To whom:
Researchers and patients candidate for spinal surgery

Conditions:
Data analysis will be done using descriptive and inferential statistics. After collecting data and encoding and logging into the computer, spss 11 will be used for analysis. To describe the data, the frequency distribution table (for qualitative variables) and the mean and standard deviation (for quantitative variables) will be used. In the analytical statistics, first, a quantitative quantitative test of normal values ​​using Kolmogorov-Smynov and Shapiro Wilk tests. To determine the homogeneity of data in three groups, the Chi-square or Fisher test for qualitative variables and the Kruskal-Wallis test will be used for quantitative variables in case of normalization. Also, intra-group comparisons will be used based on whether data are normal or not. Friedman test variance analysis will be used. To determine the relationship between underlying and intervention variables, three groups of two-way ANOVA tests will be used. For all tests, the confidence coefficient will be 95%.

Where to obtain:
Faculty of Nursing and Midwifery, Ibn Sina Avenue,Doktora st.Mashhad, Iran
  Phone:0098 5138591511 
  Fax: 0098 5138597313
  Zip Code: 9137913199
  E-mail: NMS.IT@mums.ac.ir

How to obtain:
Referring to the library of Mashhad Nursing and Midwifery Faculty and presenting the identification card to this unit and receiving the existing documentation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ommolbanin Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery,Ebne Sina Ave.,Doktora Intersection, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9166987</zip>
        <telephone>+98 51 3341 9914</telephone>
        <email>rostamio1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ommolbanin Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No,22,Hedayat 5 Ave.,Fadaeiyan 18 Blvd.,Mashhad Town</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3341 9914</telephone>
        <email>rostamio1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with thoracic and lumbar spine surgery
Complete lack of sensory and motor impairment in the lower extremities of patients who have had spine surgery
Satisfaction with co-operation during admission and continuation at home
Lack of inflammatory and vascular diseases, such as arthritis and vascular thrombosis
Absence of musculoskeletal disorders
Lack of ulcers, fractures and skin disorders in the legs
Lack of alcohol and other drugs
Lack of limb movement in the lower extremity
Not pregnant
Non-malignant diseases
Being trained or accompanying
Age of 16-70 years</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of spinal surgery
Sensory and motor disorder, complete or incomplete in lower limbs
Any wounds in the foot
Incompetent the patient or accompany of her or him</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nerve root and plexus disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The intervention is performed as a reflexology massage on the sole of the palm, with the thumb, on the inner curvature of the floor of both legs, the alternating to the wave and smoke, and in the reciprocation of about 10 -7 minutes per foot. This intervention is performed at least once a day, 3 times a week and for 6 weeks.</i_keyword>
      <i_keyword>Intervention group: </i_keyword>
      <i_keyword>Control group: </i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of pain after surgery of the thoracic sphincter and lumbar spine. Timepoint: Measuring the severity of pain in patients using the visual scale of pain in the day before surgery, the day after surgery, one week and 6 weeks after surgery in person or through telephone follow up or patient referral to the clinic of the studied hospitals. Method of measurement: Measuring the pain intensity of patients using the visual scale of pain.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-30</approval_date>
        <contact_name>regional research ethics committee Mashhad University of Medical Sciences</contact_name>
        <contact_address>Medical-Surgical Department, Nursing and Midwifery School, Ebnesina Street, Doctra Crossroad, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
