<?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>IRCT20211124053171N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-11</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Swedish massage on anxiety, sleep quality and muscle strength on conscious patients admitted to intensive care units</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Swedish massage on anxiety, sleep quality and muscle strength on conscious patients admitted to intensive care units of Khatam Al-Anbia Hospital in Iranshahr during 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60398</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples that meet the inclusion criteria will be included in the study by available sampling method and then will be assigned to the intervention and sham groups using block random allocation. The selection of blocks is based on individual characteristics.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients admitted to the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention will start from the second day of hospitalization and in this group, in addition to routine care, the whole body will be massaged. The method of massage in the intervention group is that first the mattress is placed so that the patient's mattress is not soaked in oil and the patient is given a position. Massage in such a way that the patient will be placed in a supine position with a head angle of 30-45 degrees and the coverage of the massage area will be removed and other parts of the body will be covered, and then after examining the whole body for massage prohibition, Do not have vascular disorders such as deep vein thrombosis (DVT) and fractures of the lower and upper limbs and skin diseases, wounds, infections, allergies to olive oil, in the absence of massage problems that include caressing movements, nodding, shaking and Exercises will be performed from 4 to 8 pm when the ward is more secluded and has less workload and patients are getting ready for bedtime. To perform the massage, olive oil will be used to the extent that it makes it slippery and easy to massage (10 cc). The Swedish massage will be performed once a day for 30-60 minutes each time for seven consecutive days. Swedish massage will be performed continuously with caressing and nodding movements, shaking and exercises on the upper and lower limbs and back, chest. After the massage, the patient's body will be cleaned with a towel to remove the remaining oil from the patient's body. The massage will be performed by the researcher himself / herself for female samples and also by the researcher colleague for male samples, both of whom will be trained in Swedish massage by a physiotherapist and will gain the necessary mastery in this procedure. Intervention 2: Control group: In this group, in addition to routine care, the whole body will be under simple touch. The method of touching in the sham group is that the patient is first given a position. The patient will be placed lying on his back with a head angle of 30-45 degrees and the coverage of the affected area will be removed and other parts of the body will be covered. If there is no touch problem will be done. A simple touch will be done once a day for 30-60 minutes each time for seven consecutive days. Simple touch on the upper and lower limbs and back, chest will be done continuously.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saymeh Mazarzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15,shahid kamalzadeh Ave.,Iranshahr.,Iran</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 54 3722 5140</telephone>
        <email>s.mazarzaei@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saymeh Mazarzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15,shahid kamalzadeh Ave.,Iranshahr.,Iran</address>
        <city>Iranshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 54 3722 5140</telephone>
        <email>s.mazarzaei@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
No fractures of the upper and lower limbs
Absence of neuromuscular diseases (Guillain-Barre syndrome and myasthenia gravis and botulism poisoning and pesticides, etc.)
No vascular disorders such as DVT
Four Score score thirteen and above
Do not amputate any of the limbs
No skin disease
Lack of sensitivity to olive oil
Lack of chest tube
Absence of coagulation disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Transfer to the ward in less than the first eight days of hospitalization
Four Score drops to less than 13
Create any of the disorders listed in the inclusion criteria
Samples that do not answer 20% of the questionnaire questions
Samples that have not received a maximum of 2 days of intervention</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>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention will start from the second day of hospitalization and in this group, in addition to routine care, the whole body will be massaged. The method of massage in the intervention group is that first the mattress is placed so that the patient's mattress is not soaked in oil and the patient is given a position. Massage in such a way that the patient will be placed in a supine position with a head angle of 30-45 degrees and the coverage of the massage area will be removed and other parts of the body will be covered, and then after examining the whole body for massage prohibition, Do not have vascular disorders such as deep vein thrombosis (DVT) and fractures of the lower and upper limbs and skin diseases, wounds, infections, allergies to olive oil, in the absence of massage problems that include caressing movements, nodding, shaking and Exercises will be performed from 4 to 8 pm when the ward is more secluded and has less workload and patients are getting ready for bedtime. To perform the massage, olive oil will be used to the extent that it makes it slippery and easy to massage (10 cc). The Swedish massage will be performed once a day for 30-60 minutes each time for seven consecutive days. Swedish massage will be performed continuously with caressing and nodding movements, shaking and exercises on the upper and lower limbs and back, chest. After the massage, the patient's body will be cleaned with a towel to remove the remaining oil from the patient's body. The massage will be performed by the researcher himself / herself for female samples and also by the researcher colleague for male samples, both of whom will be trained in Swedish massage by a physiotherapist and will gain the necessary mastery in this procedure.</i_keyword>
      <i_keyword>Control group: In this group, in addition to routine care, the whole body will be under simple touch. The method of touching in the sham group is that the patient is first given a position. The patient will be placed lying on his back with a head angle of 30-45 degrees and the coverage of the affected area will be removed and other parts of the body will be covered. If there is no touch problem will be done. A simple touch will be done once a day for 30-60 minutes each time for seven consecutive days. Simple touch on the upper and lower limbs and back, chest will be done continuously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Beck questionnaire. Timepoint: At the beginning of the study (before the intervention) and one week after the intervention. Method of measurement: Beck Anxiety questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality score in Spider-Halpern questionnaires. Timepoint: At the beginning of the study (before the intervention) and one week after the intervention. Method of measurement: Spider-Halper sleep quality questionnaire.</prim_outcome>
      <prim_outcome>Muscle strength score on the MRC-SS scale. Timepoint: At the beginning of the study (before the intervention) and one week after the intervention. Method of measurement: MRC-SS 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-08</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>campus of Kerman University of Medical Sciences, The beginning of Haft Bagh Alavi axis Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
