<?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>IRCT20200206046395N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-31</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of rhythmic breathing and progressive muscle relaxation on surgical site pain in patients who are candidates for abdominal hernia surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of rhythmic breathing and progressive muscle relaxation on surgical site pain in patients who are candidates for abdominal hernia surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68135</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the beginning, all the modes in which 3 letters A, B and C can be put together in a block of 6 are produced and a block is selected randomly and by placing among the blocks.The layout pattern in that block is used to allocate patients, Blinding description: Due to the nature of the study, it is not possible to blind the study participants. However, measures were taken in collecting information. After the intervention, the person collecting the information will not know the type of the participants' group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hernia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Patients in the progressive muscle relaxation intervention group learn how to perform the progressive muscle relaxation technique the day before surgery by using an educational pamphlet and providing oral training by the researcher. The training is provided by the researcher in clear and fluent sentences and. Patients are taught how to relax and contract their 16 main muscle groups according to certain principles, including the muscles of the face, hands, shoulders, legs, back, etc., keeping the muscles contracted for 3 to 5 seconds in all stages. And 10 to 15 seconds are dedicated to rest. Intervention 2: Intervention group: Patients in the rhythmic breathing group learn how to perform the rhythmic breathing technique the day before the operation by using an educational pamphlet and providing oral training by the researcher. This training is provided by the researcher using simple and understandable sentences. The technique is such that the patients are asked to close their eyes while lying on their back, inhale through the nose, then hold their breath and exhale through the mouth, and each time from number 1 to Count 3. All patients in the intervention group are instructed to focus only on inhaling and exhaling air during breathing and are asked to perform rhythmic breathing every five minutes for one minute each time for a period of 20 minutes (a total of four times every 20 minutes). Intervention 3: Control group: In the control group, no intervention will be done and they will only receive drugs and routine ward care, and only the pain intensity of the patients will be measured and recorded in the above steps.</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:
Only part of the data, such as information related to the main outcome, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
If necessary, by contacting Mobin Mottahedi and if there is a logical justification for using it for scientific purposes

Where to obtain:
Mobin Mottahedi, Shahrood, Haft Tir Square, Shahrood University of Medical Sciences; Faculty of paramedicine

How to obtain:
During a phone call or via e-mail and registering the request and stating the reason and purpose, which is logical and approved, up to two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mobin Mottahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargar Square - Nawab - Second Thought - No. 21</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3618675313</zip>
        <telephone>+98 23 3233 8090</telephone>
        <email>mobinmottahedi1372@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mobin Mottahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargar Square - Nawab - Second Thought - No. 21</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3618675313</zip>
        <telephone>+98 23 3233 8090</telephone>
        <email>mobinmottahedi1372@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>According to the American Society of Anesthesiology (ASA) classification, the patient is in grade 1 or 2
Ability to read and write persian
Age range from 18 to 75 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Addiction to drugs and painkillers
Having any psychomotor and cognitive disorders
Having a history of taking sedatives, painkillers for a period of more than one month according to the patient's self-report</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inguinal hernia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Patients in the progressive muscle relaxation intervention group learn how to perform the progressive muscle relaxation technique the day before surgery by using an educational pamphlet and providing oral training by the researcher. The training is provided by the researcher in clear and fluent sentences and. Patients are taught how to relax and contract their 16 main muscle groups according to certain principles, including the muscles of the face, hands, shoulders, legs, back, etc., keeping the muscles contracted for 3 to 5 seconds in all stages. And 10 to 15 seconds are dedicated to rest</i_keyword>
      <i_keyword>Intervention group: Patients in the rhythmic breathing group learn how to perform the rhythmic breathing technique the day before the operation by using an educational pamphlet and providing oral training by the researcher. This training is provided by the researcher using simple and understandable sentences. The technique is such that the patients are asked to close their eyes while lying on their back, inhale through the nose, then hold their breath and exhale through the mouth, and each time from number 1 to Count 3. All patients in the intervention group are instructed to focus only on inhaling and exhaling air during breathing and are asked to perform rhythmic breathing every five minutes for one minute each time for a period of 20 minutes (a total of four times every 20 minutes).</i_keyword>
      <i_keyword>Control group: In the control group, no intervention will be done and they will only receive drugs and routine ward care, and only the pain intensity of the patients will be measured and recorded in the above steps.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative pain score in VAS. Timepoint: 3, 6, 12, 24 hours after consciousness after surgery. Method of measurement: VAS visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Taking painkillers. Timepoint: At 3, 6, 12 and 24 hours after consciousness after surgery. Method of measurement: check list.</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>Shahrood University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-02</approval_date>
        <contact_name>Ethics Committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>Haft Tir Square, Shahrood University of Medical Sciences Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
