<?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>IRCT20231115060070N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-23</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Investigating Effect of acupressure on urinary control of older women</public_title>
      <acronym></acronym>
      <scientific_title>Investigating Effect of acupressure on urinary control of older women with urinary incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: For the first time, this study will measure the effect of acupressure on urinary control of elderly women in Iran. Acupressure is a cheap and accessible intervention that can be implemented by the elderly and promotes self-care behavior in the elderly. In addition, this method is a non-invasive intervention that will improve the quality of life of the elderly by controlling their urine. gave, Randomization description: a statistician who is blind to the samples will be used to randomly assign the samples. Randomization of the samples will be done with the quadruple block method; In this method, there are six different modes (bbaa'aabb'baba'abab'baab'abba) which will reach the desired sample size by selecting 20 possible blocks. In this method, it is assumed that the people in the intervention group are a and the people in the control group are b.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Urinary incontinence in  elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: To perform acupressure for the intervention group, the research team determines ten effective points in controlling the symptoms of urinary incontinence according to the opinion of an acupuncturist and also based on previous studies. Before the implementation of the intervention, the researcher discussed the intervention with the participants. she will talk about what will be done for them and give the necessary training regarding the use of drugs, especially the restriction of the use of alpha blocker drugs and sympathomimetics; In addition, the skin condition of the areas under pressure will be checked by the researcher for each elderly person in terms of fragility, and the elderly person will be asked to empty his bladder before the intervention. To start the intervention, the patient is asked to take 5 deep and correct breaths (inhalation through the nose and long exhalation through the mouth); Then the points (Liv2, Ki6, SP6, SP9, ST36) are stimulated bilaterally and the abdominal points (CR3, CR6) are pressed by the researcher alone. Next, the patient lies on his back and the remaining points (BL28, B 23, DU20) are stimulated. According to the patient's age and physical strength, the desired points will be compressed with a slow and regular rhythm and with a pressure that will feel a brief pain, which indicates the flow of qi in the body. According to the patient's appropriate state of mind and the ability to communicate (according to the AMT questionnaire), the patient was talked to during the intervention in order to maintain his peace during the intervention by announcing the satisfactory level of pressure applied to the points. In this intervention, each point will be massaged for one minute in a circular manner and will be performed for 4 weeks and 3 sessions every week with an interval of one day for the elderly, the intervention before noon will take approximately 20 minutes for each participant. Each participant will experience 12 beneficial sessions upon completion of the study. Intervention 2: Control group:The control group will not receive any complementary medicine and will be present in the test during these four weeks according to their life routine.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying individuals

When:
The access starts 6 months after the results are published

To whom:
In addition to researchers working in academic and scientific institutions, the data will be available to people working in industry

Conditions:
There are no special conditions

Where to obtain:
Email address:
sana.motalebifar78@gmail.com

How to obtain:
If you need the data, send a message to the given email address and the data will be sent to you within 48 hours

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sana Motalebifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Golestan Alley 5, Ayatollah Khamenei Boulevard, Valiasr Crossroads, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415933678</zip>
        <telephone>+98 914 985 5606</telephone>
        <email>sana.motalebifar78@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Motalebifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Golestan Alley 5, Ayatollah Khamenei Boulevard, Valiasr Crossroads, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415933678</zip>
        <telephone>+98 914 985 5606</telephone>
        <email>sana.motalebifar78@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Seniors over 60 years old
Desire to participate in this research
The ability to communicate and have a good mental state based on the ATM questionnaire (score higher than 7)
Elderly people with urinary incontinence (urgency, stress) based on the QUID questionnaire (score above 16)
Illness period of at least 3 months</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not to participate in the intervention for more than one week
Taking diuretic drugs or other drugs that reduce the symptoms of urinary incontinence during the intervention
Involvement with chronic diseases (urinary tract infection, urinary tract tumor and urinary stones) during the study
receiving similar medicine to control urinary incontinence for 1 month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the genitourinary system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: To perform acupressure for the intervention group, the research team determines ten effective points in controlling the symptoms of urinary incontinence according to the opinion of an acupuncturist and also based on previous studies. Before the implementation of the intervention, the researcher discussed the intervention with the participants. she will talk about what will be done for them and give the necessary training regarding the use of drugs, especially the restriction of the use of alpha blocker drugs and sympathomimetics; In addition, the skin condition of the areas under pressure will be checked by the researcher for each elderly person in terms of fragility, and the elderly person will be asked to empty his bladder before the intervention. To start the intervention, the patient is asked to take 5 deep and correct breaths (inhalation through the nose and long exhalation through the mouth); Then the points (Liv2, Ki6, SP6, SP9, ST36) are stimulated bilaterally and the abdominal points (CR3, CR6) are pressed by the researcher alone. Next, the patient lies on his back and the remaining points (BL28, B 23, DU20) are stimulated. According to the patient's age and physical strength, the desired points will be compressed with a slow and regular rhythm and with a pressure that will feel a brief pain, which indicates the flow of qi in the body. According to the patient's appropriate state of mind and the ability to communicate (according to the AMT questionnaire), the patient was talked to during the intervention in order to maintain his peace during the intervention by announcing the satisfactory level of pressure applied to the points. In this intervention, each point will be massaged for one minute in a circular manner and will be performed for 4 weeks and 3 sessions every week with an interval of one day for the elderly, the intervention before noon will take approximately 20 minutes for each participant. Each participant will experience 12 beneficial sessions upon completion of the study.</i_keyword>
      <i_keyword>Control group:The control group will not receive any complementary medicine and will be present in the test during these four weeks according to their life routine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary control. Timepoint: Urinary control will be measured at the beginning of the study (before the start of the intervention) and 12 sessions after the implementation of the intervention in the elderly. Method of measurement: Investigating the effect of acupressure on urinary control of elderly women with urinary incontinence, which is measured using the PRAFAB questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determining the impact of acupressure on daily life activities. Timepoint: The level of daily life activity will be measured at the beginning of the study (before the start of the intervention) and 12 sessions after the implementation of the intervention in the elderly. Method of measurement: PRAFAB questionnaire.</sec_outcome>
      <sec_outcome>Determining the effect of acupressure on self-image. Timepoint: The measurement of self-image will be measured at the beginning of the study (before the intervention) and 12 sessions after the implementation of the intervention in the elderly. Method of measurement: PRAFAB questionnaire.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-11</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>University  building, Shahid Bahonar Blvd. Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
