<?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>IRCT20180221038808N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the hypnosis effect on accelerating wound healing in oral soft tissue ulcers due to the biopsy.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the hypnosis and lidocaine effect on accelerating wound healing in oral soft tissue ulcers due to the biopsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40262</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients are randomly divided into two groups by using the binary blocks method. In this way, the fate of the two patients is determined simultaneously by random coding. For example, we obtained the following random numbers by using a calculator:
8878557034021960
To create a randomization method and the acquisition of binary blocks, we determined that if the code was 0 to 4, it would be AB, and if it was 5 to 10, it would be BA. A is the usual method, and B is a hypnosis method. By entering the first and second patient and the choice of the code 8, 8 is between 5 and 10, and BA is the B type of hypnosis, and the next is placed in the usual group, and the next number for the third and fourth patient, and so on, Blinding description: Blinding method: This study is single-blind. The evaluator had no knowledge about the photographic of patients either in hypnosis group or in the usual group which uses local anesthesia, and the procedure was performed to give each photograph a code, and the evaluator randomly assigned the edges of the ulcers without being aware of the type of hypnosis or routine surgical procedure (usual group) and then by using Photoshop software the number of pixels per ulcer was determined in the photograph.</study_design>
      <phase>4</phase>
      <hc_freetext>Accelerating of Wound Healing due to Oral Biopsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Using hypnosis: Performing hypnosis in the intervention group using the naturalistic technique performed by the hypnotherapist. In hypnosis, after deepening, hypnosis analgesia with the Dissociation approach (subjective of place and time), if necessary, using indirect inductions. At the same time, the patient was conditioned to reduce postoperative pain and increase post-operative wound healing rate after surgery. Conditioning was repeated during hypnosis induction and before the exit of the patient from hypnosis. Intervention 2: Control group: In the usual procedure, lidocaine (1.8 CC Persocaine) with epinephrine 1:100,000) was used for local anesthesia. In this group, no special material or method has been used to increase the rate of wound healing.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The satisfaction of other researchers - after the publication of the article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rosa Mostafavi Tabatabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Faculty; Mashhad University of Medical Sciences; at the beginning of Vakilabad boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٩١٧٧٩۴٨٩۵٩</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>Mostafavitr941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rosa Mostafavi Tabatabaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Faculty; Mashhad University of Medical Sciences; in front of Mellat park; at the beginning of Vakilabad boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۱۷۷۹۴۸۹۵۹</zip>
        <telephone>+98 21 2285 3639</telephone>
        <email>Rosamd80@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Soft soft tissue lesions include ulcers, reddish white, pigmented, exophytic, requiring biopsy.
Lesions need incisional or excisional biopsy.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Bad oral hygiene (through a clinical examination)
Having uncontrolled systemic diseases that causes immune system or surgical interference.
Uncontrolled Diabetes, Cushing's disease, or homeostasis problems
Taking medications that delay wound healing (such as taking steroids, etc.)
Having a psychological illness (mental illness)
Cigarette smoking and alcohol and narcotics
Having other oral mucosal diseases (except for a lesion that needs biopsy)
Malignancies (based on histopathologic diagnosis - clinical suspicion - hematologic malignancies)
Lack of proper patient hypnosis
Contraindications to hypnosis and speech or dialect barriers that reject hypnosis interventions
Previous psychosis - severe depression - personality disorders
Previous hypnosis experience</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Using hypnosis: Performing hypnosis in the intervention group using the naturalistic technique performed by the hypnotherapist. In hypnosis, after deepening, hypnosis analgesia with the Dissociation approach (subjective of place and time), if necessary, using indirect inductions. At the same time, the patient was conditioned to reduce postoperative pain and increase post-operative wound healing rate after surgery. Conditioning was repeated during hypnosis induction and before the exit of the patient from hypnosis.</i_keyword>
      <i_keyword>Control group: In the usual procedure, lidocaine (1.8 CC Persocaine) with epinephrine 1:100,000) was used for local anesthesia. In this group, no special material or method has been used to increase the rate of wound healing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PHI: Percentage of the healing index: Wound healing index: PHI = 100-PUI. Timepoint: 7 days for acceleration of wound healing. Method of measurement: dentistry Endometer - Photoshop software detects the number of pixels in each ulcer's area.PHI=100- PUI.</prim_outcome>
      <prim_outcome>PUI: Percentage of the unhealed index: Wound unhealed index:           PUI= (T1 / T0) * 100. Timepoint: 7 days for unhealed index. Method of measurement: PUI= (T1/ T0) *100.</prim_outcome>
      <prim_outcome>T: ulcer size. Timepoint: On the day of biopsy (post-cut)- Seven days after the biopsy (Suture thread opening day). Method of measurement: Endometer - Determining the number of pixels on Photoshop.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Pain the day before the biopsy- pain on the day of biopsy- pain one day after the biopsy- pain two days after the biopsy. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Preoperative- During surgery. Method of measurement: Beck’s questionaries.</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>2017-06-21</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Dental Faculty; Mashhad University of Medical Sciences; in front of Mellat park; at the beginning of Vakilabad boulevard Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
