<?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>IRCT20220608055103N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-04</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Self-Treatment Maneuver At Home In The Recovery Of Patients With Benign Paroxysmal Positional Vertigo</public_title>
      <acronym></acronym>
      <scientific_title>Investigating The effect Of Self-treatment Maneuver At Home In the Recovery of Patients With Benign Paroxysmal Positional Vertigo-A Clinical Trial Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69834</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Permuted Block Randomization Method Is Designed To Randomize Subjects Into Two Groups. It is used with a block size of 4 and an individual randomization unit. The Participants Were Randomly Assigned To Treatment Groups In Small "Blocks" Of Four Individual Participants At A Time Using SAS Software Version 9. According To The Type Of Intervention, There Is No Possibility Of Blinding. The Samples Will Be Selected From Among The People Who Referred To This Department With The Initial Complaint Of Dizziness And Imbalance And Who Stated BPPV Symptoms In The History Taking, By The Available Sampling Method By The Otolaryngologist. Interventions By The Specialist Otorhinolaryngology Will Be Performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign Paroxysmal Positional Vertigo.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the rehabilitation treatment of BPPV patients in the intervention group is done by using self-treatment positioning maneuver  maneuvers at home . In this research, modified semont maneuver will be used. Turn your head about 45 degrees away from the side affected by bppv. In this way, patients are advised to sit on the edge of the bed, put two pillows on both sides, and first put the hand under the affected ear, an angle of about 30 to 45 degrees is given upwards and turn the head 45 degrees away from the affected side. Lie down on the affected side quickly , while the ear is down and the eyes and chin are up. Wait for 20 seconds (or in case of dizziness until the episode of dizziness ends), then quickly returns to the sitting position. Then the patients should perform the same maneuver in reverse to the opposite side. They does this 2 times on the right side and 2 times on the left side (2 times per day for 3 days). Intervention 2: Control Group: In the control group, only the application maneuver is performed to treat the patients. The patient is placed from a sitting position to an open arched position. His head is turned 45 degrees to the right and remains in this position for 15 to 20 seconds. Then the head is turned to the left at an angle of 45 degrees and remains in this position for 10 to 20 seconds. Then the head is placed at a ninety degree angle so that the end part of the ear hits the ground. Then we return the patient to a sitting position. The opposite of this movement is done lying to the left.</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:
all collected deidentified IPD

When:
starting after publication

To whom:
people working in academic institutions

Conditions:
The full profile and CV of the applicants will be reviewed by Dr. Shadman Nemati.

Where to obtain:
Email: drshadmannemati_ent@yahoo.com
Address: Amir Al Mo'menin Educational Remedial &amp; Research Center, 17th Shahrivar, Rasht, Gilan Province

How to obtain:
After reviewing the applicant's information, the applicant will be contacted by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shadman Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Al Mo'menin Educational Remedial &amp; Research Center, 17th Shahrivar, Rasht, Gilan Province</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139637459</zip>
        <telephone>+98 13 3323 8307</telephone>
        <email>drshadmannemati_ent@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shadman Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir Al-Momenin (AS) Educational and Medical Center, 17 Shahrivar St., Dr. Heshmat Square, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139637459</zip>
        <telephone>+98 13 3322 5242</telephone>
        <email>drshadmannemati_ent@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A Diagnosis Of BPPV With Dix-Hallpike Maneuver And  Clinical Signs
No Previous Use Of Central Nervous System Depressants Or Stimulants In The Last 24 Hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other Causes Of Vertigo, Such As CPA Tumors, Anxiety Disorders, Confirmed Or Suspected Migraine
A Disease Or Condition For Which The Self-Treatment Maneuver, Or The Epley Maneuver Was Contraindicated, Such As Degenerative Disorders Of The Cervical Or Thoracic Spine, Detachment Of The Retina, Myocardial Infarction, Or Severe Obesity
Nystagmus That Indicates The Central Positional Nystagmus, Or Vestibular Migraine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign Paroxysmal Vertigo</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the rehabilitation treatment of BPPV patients in the intervention group is done by using self-treatment positioning maneuver  maneuvers at home . In this research, modified semont maneuver will be used. Turn your head about 45 degrees away from the side affected by bppv. In this way, patients are advised to sit on the edge of the bed, put two pillows on both sides, and first put the hand under the affected ear, an angle of about 30 to 45 degrees is given upwards and turn the head 45 degrees away from the affected side. Lie down on the affected side quickly , while the ear is down and the eyes and chin are up. Wait for 20 seconds (or in case of dizziness until the episode of dizziness ends), then quickly returns to the sitting position. Then the patients should perform the same maneuver in reverse to the opposite side. They does this 2 times on the right side and 2 times on the left side (2 times per day for 3 days).</i_keyword>
      <i_keyword>Control Group: In the control group, only the application maneuver is performed to treat the patients. The patient is placed from a sitting position to an open arched position. His head is turned 45 degrees to the right and remains in this position for 15 to 20 seconds. Then the head is turned to the left at an angle of 45 degrees and remains in this position for 10 to 20 seconds. Then the head is placed at a ninety degree angle so that the end part of the ear hits the ground. Then we return the patient to a sitting position. The opposite of this movement is done lying to the left.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Indicators Of Benign Paroxysmal Positional Vertigo According to DHI Scale. Timepoint: The Evaluation Of Patients Will Be Done Before Treatment And 1 Month Post-Treatment. Method of measurement: Dizziness Handicap Inventory Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of patient satisfaction with the effect and comfort of the treatment performed based on the scale (Visual Analogue Scale). Timepoint: Before Treatment And One Month Post-Treatment. Method of measurement: Videonystagmography (VNG).</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>Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-19</approval_date>
        <contact_name>Research Ethics Committees of Guilan university of medical sciences</contact_name>
        <contact_address>Amir Al Mo'menin Educational Remedial &amp; Research Center, 17th Shahrivar Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
