<?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>IRCT20220317054316N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-31</date_registration>
      <primary_sponsor>Yayasan Wiyata Husada Samarinda</primary_sponsor>
      <public_title>The Impact of Shiatsu Massage as a Pain Relief in Labor</public_title>
      <acronym></acronym>
      <scientific_title>EXPLORING ROLE OF SHIATSU MASSAGE AS A PAIN RELIEF IN LABOUR</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pregnant women without any co-morbidities.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (Group 1): Receive Shiatsu massages. Shiatsu massage is the method of intervention in this study. Group 1: intervention group will be given a shiatsu massage. Step 1: The massage will be given at the sacral point for a 3-second rotary pressing motion. Step 2: one thumb will be placed on top of the other thumb and pressed for 3 seconds at each pressing point Step 3: the mother's hand is wrapped around the working hand to provide support. The mother will be represented by the thumb and fingers. and press for 3 seconds at each pressing point Step 4: The second knuckle index finger is placed at the highest holy point, and then with the massager body weight, the knuckle will be rotated in a straight line down the sacrum. Intervention 2: Control group (Group 2): The pregnant women only receive usual care during pregnancy at labor.</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:
Exploring the Role of a Shiatsu Massage as a Pain Relief in Labor. 
All collected deidentified IPD. IPD will be collected for the primary and secondary outcomes only.

When:
Starting 1st July 2022

To whom:
This is only available for researchers and researchers' institutions.

Conditions:
Data will be kept confidential by the principal investigator and can only be shared by the team members. Data will be analyzed using statistical software. Any access to the data must obtain permission from all team members.

Where to obtain:
data will be collected from pregnant women in labor. Data will be kept confidential by the principal investigator. Any permission needs to contact the principal investigator.

How to obtain:
Any information about the data needs to contact the principal investigator for permission.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hestri Norhafipah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia</address>
        <city>Samarinda</city>
        <country1>Indonesia</country1>
        <zip>75243</zip>
        <telephone>+62 812-5815-2918</telephone>
        <email>hestrinorhapifah@itkeswhs.ac.id</email>
        <affiliation>institut teknologi kesehatan wiyata husada samarinda</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hestri Norhapifah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jl. Kadrie Oening Gang Monalisa No.77, Air Hitam, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia</address>
        <city>Samarinda</city>
        <country1>Indonesia</country1>
        <zip>75243</zip>
        <telephone>+62 812-5815-2918</telephone>
        <email>hestrinorhapifah@itkeswhs.ac.id</email>
        <affiliation>institut teknologi kesehatan wiyata husada samarinda</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Indonesia</country2>
      <country2>Indonesia</country2>
      <country2>Indonesia</country2>
      <country2>Indonesia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primigravida or Gravida 0 (Nulliparous)
at 37-42 weeks of gestation,
age between 20 and 35 years
having a singleton and cephalic presentation
agree to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>severe pre-eclampsia
unstable hemodynamic
physiatric disorder
comorbidities (cardiovascular, nephrology, neurology, hematology, musculoskeletal disorder) diagnosed by doctor during pregnancy
contraindicated for normal delivery
contraindicated for Shiatsu massage such as varicose veins, wounds, fractures, new scars, and areas of inflammation</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (Group 1): Receive Shiatsu massages. Shiatsu massage is the method of intervention in this study. Group 1: intervention group will be given a shiatsu massage. Step 1: The massage will be given at the sacral point for a 3-second rotary pressing motion. Step 2: one thumb will be placed on top of the other thumb and pressed for 3 seconds at each pressing point Step 3: the mother's hand is wrapped around the working hand to provide support. The mother will be represented by the thumb and fingers. and press for 3 seconds at each pressing point Step 4: The second knuckle index finger is placed at the highest holy point, and then with the massager body weight, the knuckle will be rotated in a straight line down the sacrum.</i_keyword>
      <i_keyword>Control group (Group 2): The pregnant women only receive usual care during pregnancy at labor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: T0: Baseline (at the latent phase (1 - 3 cm opening of the Os), T1: 30 minutes after intervention done at the latent phase), T2: 30 minutes after intervention given at the active (4 – 7 cm opening of the os) and transition phases (8 – 9 cm opening of the os). Method of measurement: Numeric pain rating scales  (NPRS).</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: T0: Baseline (at the latent phase (1 - 3 cm opening of the Os), T1: 30 minutes after intervention done at the latent phase), T2: 30 minutes after intervention given at the active (4 – 7 cm opening of the os) and transition phases (8 – 9 cm opening of the os). Method of measurement: Hamilton Anxiety Rating Scale (HARS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Qualitative assessment of the experience of applying shiatsu massages duirng labor. Timepoint: after deliver the baby. Method of measurement: phenomenology study using Question Plotting. Only tape recorder will be used in this section.</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>Yayasan Wiyata Husada Samarinda</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-28</approval_date>
        <contact_name>Health Research Ethic Committe. Health Polytechnic of Ministry of health East Kalimantan</contact_name>
        <contact_address>Jl. W. Monginsidi No.38, Sidodadi, Kec. Samarinda Ulu, Kota Samarinda, Kalimantan Timur 75243, Indonesia Samarinda East Kalimantan Indonesia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
