<?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>IRCT20240730062587N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-07</date_registration>
      <primary_sponsor>University Of Lahore</primary_sponsor>
      <public_title>comparison of TENS with and without labor exercises during labor.</public_title>
      <acronym>TENS (Transcutaneous Electrical Nerve Stimulation)</acronym>
      <scientific_title>COMPARATIVE EFFECTS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION AND LABOR EXERCISES ON PAIN, DURATION AND BEHAVIORAL RESPONSE OF PRIMIGRAVIDA WOMEN</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78393</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: All the screened and willing participants was randomly allocated to two groups by lottery method, Blinding description: This study was a single blinded study in which the assessor was kept blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor is one of the most thrilling times in a women’s life. Pregnant women typically have intense pain during this time. Both pharmaceutical and non-pharmacological methods exist for treating pain, and a variety of factors, such as psychological aspects or traumatic experiences in the past, can alter how pain is perceived..</hc_freetext>
      <i_freetext>Intervention 1: Experimental group A: Transcutaneous Electrical Nerve Stimulation (TENS) with Labor exercises. The study included two distinct groups: experimental and control. Participants in the experimental group had both Transcutaneous Electrical Nerve Stimulation (TENS) therapy and particular labor exercises. They were briefed on the functionality and benefits of TENS and given demonstrations. TENS electrodes were placed at the T10-L1 area. TENS was applied for 5 mins with continuous mode (frequency 150 Hz) and 5 sets of labor exercises having 5 repetitions each with interval of 45 minutes.  In addition, the experimental group did labor exercises such as deep breathing, squatting, using birth balls, pelvic rocking, and lunges, Throughout the early labor period, the investigator encouraged and supported the primigravida women in the experimental group. Intervention 2: Control Group B: Transcutaneous Electrical Nerve Stimulation (TENS) without Labor exercises. The study included two participant groups: experimental and control. The control group only got Transcutaneous Electrical Nerve Stimulation. Participants in this group were given a demonstration of TENS’s benefits and functionality. TENS electrodes were then placed in the T10-L1 area, TENS was applied for 5 mins with continuous mode (frequency 150 Hz) and 5 sets of labor exercises having 5 repetitions each with interval of 45 minutes.</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:
COMPARATIVE EFFECTS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION AND LABOR EXERCISES ON PAIN, DURATION AND BEHAVIORAL RESPONSE OF PRIMIGRAVIDA WOMEN

When:
availale

To whom:
academic institutions

Conditions:
SPSS

Where to obtain:
Sara Khan
sara.kha3035@gmail.com
03004381040

How to obtain:
postal address

Comments:
no</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Of lahore, 1-km defense road, near bhuptian chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 300 4381040</telephone>
        <email>sara.khan@uipt.uol.edu.pk</email>
        <affiliation>University Of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Fariha Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of lahore,  1-km defense road, near bhuptian chowk, lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 321 1043318</telephone>
        <email>fariha.khalid@dhpt.uol.edu.pk</email>
        <affiliation>University Of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Females
20-35 years
Primigravida women with 38 weeks to 40 weeks’ gestation
First stage of labor
Cervical dilatation 3 cms to 4 cms as per vaginal findings
Physically Active</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Female with any other uterine issue
Cervical cerclage
Hypertension
Urinary Incontinence
Diagnosed Psychological issues.</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>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group A: Transcutaneous Electrical Nerve Stimulation (TENS) with Labor exercises. The study included two distinct groups: experimental and control. Participants in the experimental group had both Transcutaneous Electrical Nerve Stimulation (TENS) therapy and particular labor exercises. They were briefed on the functionality and benefits of TENS and given demonstrations. TENS electrodes were placed at the T10-L1 area. TENS was applied for 5 mins with continuous mode (frequency 150 Hz) and 5 sets of labor exercises having 5 repetitions each with interval of 45 minutes.  In addition, the experimental group did labor exercises such as deep breathing, squatting, using birth balls, pelvic rocking, and lunges, Throughout the early labor period, the investigator encouraged and supported the primigravida women in the experimental group.</i_keyword>
      <i_keyword>Control Group B: Transcutaneous Electrical Nerve Stimulation (TENS) without Labor exercises. The study included two participant groups: experimental and control. The control group only got Transcutaneous Electrical Nerve Stimulation. Participants in this group were given a demonstration of TENS’s benefits and functionality. TENS electrodes were then placed in the T10-L1 area, TENS was applied for 5 mins with continuous mode (frequency 150 Hz) and 5 sets of labor exercises having 5 repetitions each with interval of 45 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 5 times after intervention with 45 mins interval. Method of measurement: Wong baker faces pain scale.</prim_outcome>
      <prim_outcome>Behavioral Response. Timepoint: 5 times after intervention with 45 mins interval. Method of measurement: behavioral pain 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>University Of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-27</approval_date>
        <contact_name>Research Ethics Committee</contact_name>
        <contact_address>University of Lahore near bhuptian chowk,1km defense road, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
