<?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>IRCT20230911059401N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-11</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the effect of Benson relaxation and music therapy on fear of movement  and postoperative pain in patients undergoing lumbar disc herniation surgery</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of Benson relaxation and music therapy on fear of movement  and postoperative pain in patients undergoing lumbar disc herniation surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72520</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To allocate the samples, the block randomization method will be used with the size of 6 blocks, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for the three groups, Blinding description: The present study is single blind.
Due to the nature of the study, it is not possible to blind the study participants. However, measures have been taken in collecting information. The person collecting information will not be aware of the type of group of people after the intervention. . Also, in the statistical file and questionnaires, the groups are identified as codes, and the analyst does not know about the assignment of codes to the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of movement, Low back pain, lumbar disc herniation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (Benson Relaxation Group): In order to perform the correct Benson relaxation technique, this technique will be performed with the following sequence. The patient is asked to lie down in a comfortable position and close his eyes, to remove disturbing thoughts from his mind as much as possible. They are asked to choose a word that always reminds them of peace. Then slowly relax your muscles from the bottom of the body to the top and at the same time slowly start breathing deeply (in such a way that inhale through the nose and exhale through the mouth). Do not think and continue this exercise for at least 20 minutes. Finally, the patient is asked to open his eyes slowly, so that the body is motionless for a few minutes. The first day after the operation, when the pain and fear of movement are the most intense, therefore, the interventions are performed in two times with an interval of twelve hours at 9 am and 9 pm in the surgical department for 20 minutes. Intervention 2: Intervention group 2 (Music therapy group): Second group (music therapy group): Participants in the other group listen to wordless music for 20 minutes through an audio player. In the music therapy group, the song Weightless by Macaroni Union will be chosen as the wordless music. The melodies of this song have no repetitive pattern and its rhythm varies continuously between 50 and 60 bits per minute. The first day after the operation, when the pain and fear of movement are the most intense, therefore, the interventions are performed in two times with an interval of twelve hours at 9 am and 9 pm in the surgical department for 20 minutes. Intervention 3: Control group: In the control group, participants will receive only routine care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>majid bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Medical Sciences, Haft Tir Square, Shahrood</address>
        <city>shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73943</zip>
        <telephone>+98 23 3251 2173</telephone>
        <email>majidbagheri.96913@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>majid bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Medical Sciences, Haft Tir Square, Shahrood</address>
        <city>shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3655117701</zip>
        <telephone>+98 23 3251 2173</telephone>
        <email>majidbagheri.96913@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Perform discectomy surgery
Being 18 years of age or older
Having spontaneous breathing
Ability to read and write in Persian
Ability to learn or perform the Benson technique correctly
Desire to listen to music
Consent to participate in the research verbally and in writing
Discectomy by open surgery
Having a score of at least 37 in the Tempa questionnaire before the operation
Having a pain score of at least 3 before surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Addiction to sedatives
lack of consciousness
causing any side effects in terms of infection, bleeding, severe pain, etc. until the end of evaluation and interventions
Having language, hearing or vision disorders
Having experience using relaxation methods in the past
Having a history of previous discectomy surgery
Having a history of taking sedatives, painkillers for a period of more than one month according to the patient's self-report
Having a history of mental disorders and diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 (Benson Relaxation Group): In order to perform the correct Benson relaxation technique, this technique will be performed with the following sequence. The patient is asked to lie down in a comfortable position and close his eyes, to remove disturbing thoughts from his mind as much as possible. They are asked to choose a word that always reminds them of peace. Then slowly relax your muscles from the bottom of the body to the top and at the same time slowly start breathing deeply (in such a way that inhale through the nose and exhale through the mouth). Do not think and continue this exercise for at least 20 minutes. Finally, the patient is asked to open his eyes slowly, so that the body is motionless for a few minutes. The first day after the operation, when the pain and fear of movement are the most intense, therefore, the interventions are performed in two times with an interval of twelve hours at 9 am and 9 pm in the surgical department for 20 minutes.</i_keyword>
      <i_keyword>Intervention group 2 (Music therapy group): Second group (music therapy group): Participants in the other group listen to wordless music for 20 minutes through an audio player. In the music therapy group, the song Weightless by Macaroni Union will be chosen as the wordless music. The melodies of this song have no repetitive pattern and its rhythm varies continuously between 50 and 60 bits per minute. The first day after the operation, when the pain and fear of movement are the most intense, therefore, the interventions are performed in two times with an interval of twelve hours at 9 am and 9 pm in the surgical department for 20 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, participants will receive only routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of movement. Timepoint: Once in the morning after the operation, and once in the morning two days after the operation. Method of measurement: Tampa Scale for Kinesiophobia.</prim_outcome>
      <prim_outcome>Postoperative pain. Timepoint: Once in the morning after the operation, and once in the morning two days after the operation. 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-11</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, Haft Tir Square, Shahroud Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
