<?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>IRCT20200206046395N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-15</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of massage therapy and transcutaneous electrical nerve stimulation (TENS) on anxiety, fatigue and sleep quality of patients undergoing coronary artery bypass graft</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of massage therapy and transcutaneous electrical nerve stimulation (TENS) on anxiety, fatigue and sleep quality of patients undergoing coronary artery bypass graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77323</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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>Chronic ischaemic heart disease, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: In the massage group, the classic massage procedure will be applied to the patient's hands without using any special equipment and will include the combination of 3 therapeutic massage methods: kneading, friction and petrissage. Massage will be done on both hands for 30 minutes, i.e. 15 minutes on each hand. Intervention 2: Intervention group: In the TENS group, the electrodes will be placed in the PC7 and LI4 regions. TENS with a frequency of 60 Hz, an electric current of 4 to 7 milliamp and a pulse duration of 0.25 milliseconds will be used for 30 minutes, so that the stimulation effect does not cause discomfort and muscle contraction in the patient. Intervention 3: Control group: In the control group, standard and routine care will be performed in the inpatient department after CABG surgery.</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>Mobin Mottahedi</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>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>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>Mobinmottahedi1372@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing CABG surgery
No previous use of alcohol, sedative and anti-anxiety drugs or narcotics
Not using complementary medicine methods during the previous three months
Absence of wounds, phlebitis, trauma and arthritis in the massage area</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous diagnosis of sleep disorders
Loss of consciousness and need for mechanical ventilation more than 24 hours after surgery
Contraindications to TENS use such as pregnancy, epilepsy and skin disorders in the area where the electrodes are used
Patients with severe communication disorder and unstable vital signs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: In the massage group, the classic massage procedure will be applied to the patient's hands without using any special equipment and will include the combination of 3 therapeutic massage methods: kneading, friction and petrissage. Massage will be done on both hands for 30 minutes, i.e. 15 minutes on each hand.</i_keyword>
      <i_keyword>Intervention group: In the TENS group, the electrodes will be placed in the PC7 and LI4 regions. TENS with a frequency of 60 Hz, an electric current of 4 to 7 milliamp and a pulse duration of 0.25 milliseconds will be used for 30 minutes, so that the stimulation effect does not cause discomfort and muscle contraction in the patient.</i_keyword>
      <i_keyword>Control group: In the control group, standard and routine care will be performed in the inpatient department after CABG surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: First, on the second day after the operation (before the intervention), the sleep quality of the patients will be evaluated. Then, after the end of the intervention period, on the morning of the fifth day after the operation, the quality of sleep will be evaluated again. Method of measurement: Richards–Campbell Sleep Questionnaire (RCSQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: First, on the second day after the operation (before the intervention), the patients' anxiety will be evaluated. Then, after the end of the intervention period, on the morning of the fifth day after the operation, anxiety will be evaluated again. Method of measurement: The State-Trait Anxiety Inventory (STAI).</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: First, on the second day after the operation (before the intervention), the fatigue of the patients will be evaluated. Then, after the end of the intervention period, on the morning of the fifth day after the operation, fatigue will be assessed again. Method of measurement: The multidimensional fatigue inventory (MFI-20).</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>2024-06-02</approval_date>
        <contact_name>Ethics Committee of Shahrood 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>
