<?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>IRCT2016021126522N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-15</date_registration>
      <primary_sponsor>Deputy of Research and Technology of yasuj University of medical science.</primary_sponsor>
      <public_title>Jacobson relaxation and Hugo point massage impact on vital signs and pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of jackobson relaxation method and Hugo point massage on Vital sign and severity of pain in patients with cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cholecystectomy.</hc_freetext>
      <i_freetext>The samples Based on a random table, randomly assigned to experimental groups Hugo point massage, relaxation Jacobson and will be the control group. The number of samples for each group, 25 patients and in total, 75 people will be studied. For each of them about how to do research, and the aim of study, then Informed consent of the patient Will be taken and Will ensure .that the above-mentioned method, there is no harm and Will not disruptions in the process of  his care. In this study use demographic questionnaire and standardized numerical pain scale (10-0) for collect information. To check vital signs, the patient's vital signs before and after intervention data will be checked and entry to form. Therefore, the normal respiratory rate of 12 to 20, less than 12 Bradypnea and over 20 will be considered tachypnea.Use phygmomanometer to measure blood pressure of patients.  if systolic pressure ranging from 140 to 110 mm Hg and diastolic blood pressure 90-80 mm Hg is considered normal. Palpating the patient's pulse rate with the help of over a minute to be counted and considered normal in the 60-100 range and fewer than 60 bradycardia and tachycardia in the top 100 will be considered. &#13;
The intervention will continue for three days. And until the patients in the hospital and after discharge interventions in the hospital until three days interventions will be done in the home environment.&#13;
 Protocol Hugo point massage: massage of the people will be asked to put in the required position. So researchers will be facing. when the pain on the patient more than 3 score on a numerical pain scale a researcher put his  his thumb on right hand of patient and use small bag of ice for  pressure on the patient's right hand (hugo point). To prevent discomfort, pressure for deep and back - strength beyond that point forward Hugo and as far as change in nail color will be applied researcher. This procedure  repeat  three times, so repeated then people explain their pain on a numerical rating scale to determine pain. To search for Suitable of time and its effectiveness of procedure will asked DeQi emotions collection including feeling of heat, numbness, numbness, pain, heaviness and relaxation.&#13;
&#13;
Jacobson relaxation protocol: in this group relaxation techniques Jacobson (progressive muscle relaxation and deep breathing) will be used. 6 relaxation sessions over the three days, each session for 30 minutes for patients in the experimental group will be done. the data from the forms and numerical pain scale observation and examination, will be extracted. Educational program in the first session, including progressive relaxation technique for practical steps will be. The relaxation will be monitored by patients. Patients will be asked every single muscle in relaxation of the muscles of the foot and facial muscles, including 16muscles, the first contract and then relax. Patients his muscles twitched and then counted by counting the number 5 to number 10 will loose. The same steps as for the feet and legs, thighs, abdomen, chest, buttocks, hands and forearms, arms, shoulders, neck, forehead, tongue and jaw, eyes and face will repeat until you feel Shell has integrated their entire body. During the relaxation time patients will take a deep breath. Selection mode to relaxation mode is lying. In subsequent meetings and relaxation process will be explained to the patient by the investigator and the patient's description of relaxation researcher to researcher will run under. Control: There will be no intervention in the control group. Patients in the usual care group received and it will be completed only by means of research. &#13;
The amount and type of housing by patients before and during the intervention will be compared with each other in the checklist..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>shahla najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasvj- Street of  shahid jalil - School of Nursing and Midwifery</address>
        <city>yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 341 2047</telephone>
        <email>shahla88@gmail.comrezanejad2014@gmail.com</email>
        <affiliation>School of Nursing and Midwifery of Yasouj</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.ardeshir afrasiabifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj- Street shahid jalil - School of Nursing and Midwifery</address>
        <city>yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 341 1267</telephone>
        <email>afrasiabifar@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery of Yasouj</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 is laparoscopic surgery, organ health of the hands, especially the thumb, having a higher average pain severity (based on a numeric scale of pain intensity 3 and uper), do not  member of  Health care providers, gaining full consciousness after the surgery, not addicted to narcotics, sedatives, alcohol, etc., lack of sensory and motor disorders, lack of hearing impairment, lack of any other physical and mental disorders from recent surgery, no history of use Hugo point massage and relaxation Jacobson, lack of chronic pain in other parts of the body, such as migraine, low back pain and so on.&#13;
 Exclusion criteria:&#13;
 severe post-operative complications during hospitalization, such as severe bleeding, edema, acute infections, need more care and transferred to the intensive care unit after surgery, use illegal drugs (except substances that are part of the routine management patient (eg, petedine)), sedatives, alcohol, diabetes, patient dissatisfaction and lack of access to appropriate conditions to continue research ..</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute cholecystitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The samples Based on a random table, randomly assigned to experimental groups Hugo point massage, relaxation Jacobson and will be the control group. The number of samples for each group, 25 patients and in total, 75 people will be studied. For each of them about how to do research, and the aim of study, then Informed consent of the patient Will be taken and Will ensure .that the above-mentioned method, there is no harm and Will not disruptions in the process of  his care. In this study use demographic questionnaire and standardized numerical pain scale (10-0) for collect information. To check vital signs, the patient's vital signs before and after intervention data will be checked and entry to form. Therefore, the normal respiratory rate of 12 to 20, less than 12 Bradypnea and over 20 will be considered tachypnea.Use phygmomanometer to measure blood pressure of patients.  if systolic pressure ranging from 140 to 110 mm Hg and diastolic blood pressure 90-80 mm Hg is considered normal. Palpating the patient's pulse rate with the help of over a minute to be counted and considered normal in the 60-100 range and fewer than 60 bradycardia and tachycardia in the top 100 will be considered. &#13;
The intervention will continue for three days. And until the patients in the hospital and after discharge interventions in the hospital until three days interventions will be done in the home environment.&#13;
 Protocol Hugo point massage: massage of the people will be asked to put in the required position. So researchers will be facing. when the pain on the patient more than 3 score on a numerical pain scale a researcher put his  his thumb on right hand of patient and use small bag of ice for  pressure on the patient's right hand (hugo point). To prevent discomfort, pressure for deep and back - strength beyond that point forward Hugo and as far as change in nail color will be applied researcher. This procedure  repeat  three times, so repeated then people explain their pain on a numerical rating scale to determine pain. To search for Suitable of time and its effectiveness of procedure will asked DeQi emotions collection including feeling of heat, numbness, numbness, pain, heaviness and relaxation.&#13;
&#13;
Jacobson relaxation protocol: in this group relaxation techniques Jacobson (progressive muscle relaxation and deep breathing) will be used. 6 relaxation sessions over the three days, each session for 30 minutes for patients in the experimental group will be done. the data from the forms and numerical pain scale observation and examination, will be extracted. Educational program in the first session, including progressive relaxation technique for practical steps will be. The relaxation will be monitored by patients. Patients will be asked every single muscle in relaxation of the muscles of the foot and facial muscles, including 16muscles, the first contract and then relax. Patients his muscles twitched and then counted by counting the number 5 to number 10 will loose. The same steps as for the feet and legs, thighs, abdomen, chest, buttocks, hands and forearms, arms, shoulders, neck, forehead, tongue and jaw, eyes and face will repeat until you feel Shell has integrated their entire body. During the relaxation time patients will take a deep breath. Selection mode to relaxation mode is lying. In subsequent meetings and relaxation process will be explained to the patient by the investigator and the patient's description of relaxation researcher to researcher will run under. Control: There will be no intervention in the control group. Patients in the usual care group received and it will be completed only by means of research. &#13;
The amount and type of housing by patients before and during the intervention will be compared with each other in the checklist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain and vital signs. Timepoint: 3 days. Method of measurement: Numerical Scale of pain (NRS) and the vital sign form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reducing pain and improving vital signs. Timepoint: 3 days. Method of measurement: The numeric scale of pain and vital sign form.</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>Deputy of Research and Technology of yasuj University of medical science.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-08</approval_date>
        <contact_name>Ethics Committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, Deputy of Research and Technology,Yasuj University of Medical Sciences, Jhad Square Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
