<?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>IRCT20110906007494N45</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-16</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on the fear and stress of dialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on fear and stress amounts of emergency hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76317</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, stratified random block method will be used. The randomization unit will be individual and in blocks of 3 people. To make a 3-person block, patients will be matched (classified) according to the gender variable. Next, in each block, patients will receive numbers 1 to 3 according to their arrival, and according to the A, B, C codes generated by the software, allocation will be done. Code A will be considered for the acupressure group, B for the sham intervention group, and C for the control group. The codes will be placed in the sealed envelope and the number of each patient will be written on the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: stress. Condition 2: fear.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: after introducing and stating the objectives of the study and obtaining written informed consent and getting the patient's cooperation to conduct the study in the first hour after the patient was connected to the hemodialysis machine, the demographic and medical information form including age, gender, occupation, marital status, Education level, place of residence, history of dialysis, underlying disease history, emergency cause of hemodialysis and vascular access ways, fear survey, stress survey and short mental status survey tool will be completed. Then, one hour after the start of hemodialysis, the first round of intervention will be performed by the therapist, and immediately after the first round of intervention, the fear and stress tool will be completed. Two hours after the start of hemodialysis, the second round of acupressure will be performed and the fear and stress of hemodialysis patients will be checked again. The fourth time will be to assess the fear and stress of the patients immediately before isolating the patients. In the acupressure group, at each round of intervention, pressure points BL60, K3, GB20, SP6, K1 and Gv29 are subjected to pressure massage by the researcher's fingers for three minutes each for a total of 18 minutes. The point BL60 (Kun Lun) next to the outer ankle of the foot is the end of the Achilles tendon. The K3 point (Taixi) is located in the middle of the distance between the inner ankle and the Achilles tendon. Point GB20 (Fengchi) is located between the base of the skull and the top of the neck, on the side of the tendons of the trapezius muscle. Point SP6 (Sanyinjiao) is located on the inner side of the lower leg and at a distance of three CUN above the inner part of the inner ankle of the leg, in the posterior line and next to the tibia bone on the spleen channel. K1 point (Yongquan) is the junction of the anterior third and posterior two thirds of the sole between the second and third toes. Point Gv29 (Yin Tang) is located in the middle between the two eyebrows. Intervention 2: False intervention group: After introducing and stating the objectives of the study and obtaining written informed consent and getting the patient's cooperation to conduct the study, in the first hour after the patient is connected to the hemodialysis machine, the demographic and medical information form and the fear and stress assessment tool will be completed. Then, one hour after the start of hemodialysis, the first round of false intervention will be performed, and immediately after the first round of false intervention, the fear and stress tool will be completed. Two hours after the start of hemodialysis, the second round of false intervention will be performed and the fear and stress of hemodialysis patients will be checked again. The fourth time will be to assess the fear and stress of the patients immediately before isolating the patients. In this group, the intervention is two centimeters away from point K1 and GB20 to the right or left side, two centimeters away from point K3 and BL60 towards the ankle, two centimeters away from point SP6 towards the front of the foot and in the distance Two centimeters from the Gv29 point to the left or right side will be done one and two hours after the start of hemodialysis.  points BL60, K3, GB20, SP6, K1 and Gv29 will be subjected to pressure massage by the researcher's fingers for three minutes each for a total of 18 minutes. In this group and the acupressure group, the amount of pressure of 3 kg will be determined in such a way that the researcher puts pressure on a scale with his thumb until the scale is fixed on the number 3 kg, and then with the same amount of pressure on It will put pressure on acupressure points.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 7551</telephone>
        <email>mbagheri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3336 7551</telephone>
        <email>mbagheri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Emergency hemodialysis candidate based on nephrologist's diagnosis
Mental alertness and absence of moderate and severe cognitive impairment based on Mini Mental State Examination
A history of at least 6 months of hemodialysis
Absence of limb amputation or wound at the place of pressure points
Patients who have a score of 44 or higher based on the visual analog scale of fear
Patients who have a score of 44 or higher based on the  visual analog scale of stress
Not suffering from acute mental disorders (panic attacks and anxiety disorders) and not taking sedatives such as benzodiazepines 2 weeks before the visit
Not using accompanying treatment methods such as acupuncture, hypnosis or yoga during the last six months
Not experiencing stressful events in the past six weeks
No use of opium within five hours before the start of hemodialysis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
The need for cardiopulmonary resuscitation following hemodynamic changes during hemodialysis
Decreasing the level of consciousness of patients during hemodialysis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.0</hc_code>
      <hc_code>Z71.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
      <hc_keyword>Person with feared health complaint in whom no diagnosis is made</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: after introducing and stating the objectives of the study and obtaining written informed consent and getting the patient's cooperation to conduct the study in the first hour after the patient was connected to the hemodialysis machine, the demographic and medical information form including age, gender, occupation, marital status, Education level, place of residence, history of dialysis, underlying disease history, emergency cause of hemodialysis and vascular access ways, fear survey, stress survey and short mental status survey tool will be completed. Then, one hour after the start of hemodialysis, the first round of intervention will be performed by the therapist, and immediately after the first round of intervention, the fear and stress tool will be completed. Two hours after the start of hemodialysis, the second round of acupressure will be performed and the fear and stress of hemodialysis patients will be checked again. The fourth time will be to assess the fear and stress of the patients immediately before isolating the patients. In the acupressure group, at each round of intervention, pressure points BL60, K3, GB20, SP6, K1 and Gv29 are subjected to pressure massage by the researcher's fingers for three minutes each for a total of 18 minutes. The point BL60 (Kun Lun) next to the outer ankle of the foot is the end of the Achilles tendon. The K3 point (Taixi) is located in the middle of the distance between the inner ankle and the Achilles tendon. Point GB20 (Fengchi) is located between the base of the skull and the top of the neck, on the side of the tendons of the trapezius muscle. Point SP6 (Sanyinjiao) is located on the inner side of the lower leg and at a distance of three CUN above the inner part of the inner ankle of the leg, in the posterior line and next to the tibia bone on the spleen channel. K1 point (Yongquan) is the junction of the anterior third and posterior two thirds of the sole between the second and third toes. Point Gv29 (Yin Tang) is located in the middle between the two eyebrows</i_keyword>
      <i_keyword>False intervention group: After introducing and stating the objectives of the study and obtaining written informed consent and getting the patient's cooperation to conduct the study, in the first hour after the patient is connected to the hemodialysis machine, the demographic and medical information form and the fear and stress assessment tool will be completed. Then, one hour after the start of hemodialysis, the first round of false intervention will be performed, and immediately after the first round of false intervention, the fear and stress tool will be completed. Two hours after the start of hemodialysis, the second round of false intervention will be performed and the fear and stress of hemodialysis patients will be checked again. The fourth time will be to assess the fear and stress of the patients immediately before isolating the patients. In this group, the intervention is two centimeters away from point K1 and GB20 to the right or left side, two centimeters away from point K3 and BL60 towards the ankle, two centimeters away from point SP6 towards the front of the foot and in the distance Two centimeters from the Gv29 point to the left or right side will be done one and two hours after the start of hemodialysis.  points BL60, K3, GB20, SP6, K1 and Gv29 will be subjected to pressure massage by the researcher's fingers for three minutes each for a total of 18 minutes. In this group and the acupressure group, the amount of pressure of 3 kg will be determined in such a way that the researcher puts pressure on a scale with his thumb until the scale is fixed on the number 3 kg, and then with the same amount of pressure on It will put pressure on acupressure points.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: 1 hour after connecting the patient to the hemodialysis machine and immediately after the first intervention (1hour after the start of hemodialysis), immediately after the second intervention (2 hours after the start of hemodialysis) and immediately before separating the patient from the hemodialysis machine. Method of measurement: A visual analog scale for measuring stress intensity with a 100 mm graduated ruler.</prim_outcome>
      <prim_outcome>Fear. Timepoint: 1 hour after connecting the patient to the hemodialysis machine and immediately after the first intervention (1hour after the start of hemodialysis), immediately after the second intervention (2 hours after the start of hemodialysis) and immediately before separating the patient from the hemodialysis machine. Method of measurement: A visual analog scale for measuring fear intensity with a 100 mm graduated ruler.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-17</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square. , Sari, mazandaran, Iran. Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
