<?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>IRCT20210908052405N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-25</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of reflexology and reflexology with aromatherapy on chronic low back pain and mood of female operating room staff</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of reflexology and reflexology with aromatherapy on chronic low back pain and mood of female operating room staff</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58641</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, the units under study are selected by convenient sampling. In this way, all the people who meet the inclusion criteria are selected and then the substitution in the groups will be done randomly by the minimization method using the mini-foot software. According to the parameters that we define for the software, the research unit is divided into three groups so that there will be at least a difference between them. In this way, after the selection, the subject is given a unique code that indicates the study group and in their questionnaire, it will be stated that 35 subjects based on the minimization list in the reflection therapy group, 35 subjects in the reflection therapy group Along with aromatherapy, 35 subjects will be in the control group. In this study, minimization will be performed based on parameters such as age, marital status, employment status, duration of low back pain, Blinding description: Blinding will be such that both the statistical consultant and the questioner will not be aware of the type of intervention in the units under study. The questionnaire will be distributed by the researcher and completed by the research units.</study_design>
      <phase>3</phase>
      <hc_freetext>Low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Lavender oil-free reflexology intervention group: Before the intervention, the patient's low back pain is measured by the questioner using the McGill Pain Questionnaire and the numerical pain scale. The intervention is immediate (three times a week), one month later (three times in Week) and then three months later (three times a week) for a total of 9 sessions over 4 months. The researcher will conduct his research in the room that will be considered in the operating room, all the units will be given a disposable towel and shampoo for washing the feet and a disposable sheet. Before starting the massage, the subjects will wash their feet with body wash shampoo and dry them with a towel. To begin the massage technique, the person will first lie on their back and a pillow will be placed under their head to facilitate the intervention, and then the patient's pants will rise to the knee and the researcher will be in front of the patient. First, the feet will be examined for lumps, pain, tenderness, and any dryness or swelling. Then a simple and superficial massage (superficial stroke) is given for 2 minutes, which is a relaxation technique and will relax the foot and prepare for a specific reflexology treatment. First, a general reflexology will be used for 18 minutes on all reflex points in the sole of the foot and then 5 minutes of specialized reflexology. These points include the solar plexus, the pituitary gland, and the heart, each of which will be massaged with a thumb and constant pressure. The rest of the soles of the feet and some parts of the feet will be massaged continuously on the reflection points without interrupting contact with the skin, using the thumbs or other toes. The external side and sole of the foot will be massaged for one to two minutes each. The massage is performed under the toes with the movements of the thumb and in an arched shape from left to right for one to two minutes, which includes points related to the heart, lungs and chest. Then the rest of the time will be devoted to massaging the points related to the lumbar region in the arched part of the inner side of the foot. The index and middle fingers are used, which will be placed on the reflex points. The fingers will be far apart and close, and a movement similar to a tree worm will be performed on reflex points. Intervention 2: Control group:There will be no intervention in the control group, but a gift will be considered for them to participate in the research. Intervention 3: Lavender oil reflexology intervention group: Before the intervention, the person's low back pain is measured by the questioner using the McGill pain questionnaire and the numerical pain scale. The intervention is immediate (three times a week), one month later (three times in Week) and then three months later (three times a week) for a total of 9 sessions over 4 months. This group will be evaluated for sensitivity to lavender oil (by testing skin patches) by rubbing a drop of oil on the inside of the wrist, then examining the signs of allergies after two minutes to be excluded in case of allergies. The researcher will conduct his research in the room that will be considered in the operating room, all the units will be given a disposable towel and shampoo for washing the feet and a disposable sheet. Before starting the massage, the subjects will wash their feet with body wash shampoo and dry with a towel. Pour a drop of lavender oil on an unabsorbable napkin and attach it to the subject's neck with a pin, and the person will receive a reflection. Therapy also inhales lavender oil at the same time. This oil is a greenish-yellow liquid and is obtained by distilling the flowers and flowering branches of the lavender plant, and each drop of it is equivalent to 28 grams of the plant, which is prepared by Baric Essential Pharmaceutical Company. To begin the massage technique, the person will first lie on their back and a pillow will be placed under their head to facilitate the intervention, and then the patient's pants will rise to the knee and the researcher will be in front of the patient. First, the feet will be examined for lumps, pain, tenderness, and any dryness or swelling. Then a simple and superficial massage (superficial stroke) is given for 2 minutes, which is a relaxation technique and will relax the foot and prepare for a specific reflexology treatment. First, a general reflexology will be used for 18 minutes on all reflex points in the sole of the foot and then 5 minutes of specialized reflexology. These points include the solar plexus, the pituitary gland, and the heart, each of which will be massaged with a thumb and constant pressure. The rest of the soles of the feet and some parts of the feet will be massaged continuously on the reflection points without interrupting contact with the skin, using the thumbs or other toes. The external side and sole of the foot will be massaged for one to two minutes each. The massage is performed under the toes with the movements of the thumb and in an arched shape from left to right for one to two minutes, which includes points related to the heart, lungs and chest. Then the rest of the time will be devoted to massaging the points related to the lumbar region in the arched part of the inner side of the foot. The index and middle fingers are used, which will be placed on the reflex points. The fingers will be far apart and close, and a movement similar to a tree worm will be performed on reflex 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All personal data of study participants are potentially shared after unidentifiable individuals.

When:
Access period starts 6 months after the publication of the results, ie from 26/8/2022

To whom:
Researchers working in academic institutions

Conditions:
Just to study and get acquainted with the research process

Where to obtain:
The first researcher, Zahra Shafiei, shafieiznm@gmail.com

How to obtain:
Give the request letter to the researcher's email and then send the request items by the researcher within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra shafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8171914716</zip>
        <telephone>+98 31 3792 2901</telephone>
        <email>shafieiznm@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra shafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8171914716</zip>
        <telephone>+98 31 3792 2901</telephone>
        <email>shafieiznm@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having complete satisfaction with participating in the study
Have chronic low back pain based on a specialist doctor's diagnosis.
Participants do not have acute pain or need surgery.
Have organ health in the feet, especially the soles of the feet.
No history of allergies to medicinal plants</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance of research units to continue participating in the study
Allergies to used oils
Suffering from mental and emotional trauma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intervertebral disc disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Lavender oil-free reflexology intervention group: Before the intervention, the patient's low back pain is measured by the questioner using the McGill Pain Questionnaire and the numerical pain scale. The intervention is immediate (three times a week), one month later (three times in Week) and then three months later (three times a week) for a total of 9 sessions over 4 months. The researcher will conduct his research in the room that will be considered in the operating room, all the units will be given a disposable towel and shampoo for washing the feet and a disposable sheet. Before starting the massage, the subjects will wash their feet with body wash shampoo and dry them with a towel. To begin the massage technique, the person will first lie on their back and a pillow will be placed under their head to facilitate the intervention, and then the patient's pants will rise to the knee and the researcher will be in front of the patient. First, the feet will be examined for lumps, pain, tenderness, and any dryness or swelling. Then a simple and superficial massage (superficial stroke) is given for 2 minutes, which is a relaxation technique and will relax the foot and prepare for a specific reflexology treatment. First, a general reflexology will be used for 18 minutes on all reflex points in the sole of the foot and then 5 minutes of specialized reflexology. These points include the solar plexus, the pituitary gland, and the heart, each of which will be massaged with a thumb and constant pressure. The rest of the soles of the feet and some parts of the feet will be massaged continuously on the reflection points without interrupting contact with the skin, using the thumbs or other toes. The external side and sole of the foot will be massaged for one to two minutes each. The massage is performed under the toes with the movements of the thumb and in an arched shape from left to right for one to two minutes, which includes points related to the heart, lungs and chest. Then the rest of the time will be devoted to massaging the points related to the lumbar region in the arched part of the inner side of the foot. The index and middle fingers are used, which will be placed on the reflex points. The fingers will be far apart and close, and a movement similar to a tree worm will be performed on reflex points.</i_keyword>
      <i_keyword>Control group:There will be no intervention in the control group, but a gift will be considered for them to participate in the research.</i_keyword>
      <i_keyword>Lavender oil reflexology intervention group: Before the intervention, the person's low back pain is measured by the questioner using the McGill pain questionnaire and the numerical pain scale. The intervention is immediate (three times a week), one month later (three times in Week) and then three months later (three times a week) for a total of 9 sessions over 4 months. This group will be evaluated for sensitivity to lavender oil (by testing skin patches) by rubbing a drop of oil on the inside of the wrist, then examining the signs of allergies after two minutes to be excluded in case of allergies. The researcher will conduct his research in the room that will be considered in the operating room, all the units will be given a disposable towel and shampoo for washing the feet and a disposable sheet. Before starting the massage, the subjects will wash their feet with body wash shampoo and dry with a towel. Pour a drop of lavender oil on an unabsorbable napkin and attach it to the subject's neck with a pin, and the person will receive a reflection. Therapy also inhales lavender oil at the same time. This oil is a greenish-yellow liquid and is obtained by distilling the flowers and flowering branches of the lavender plant, and each drop of it is equivalent to 28 grams of the plant, which is prepared by Baric Essential Pharmaceutical Company. To begin the massage technique, the person will first lie on their back and a pillow will be placed under their head to facilitate the intervention, and then the patient's pants will rise to the knee and the researcher will be in front of the patient. First, the feet will be examined for lumps, pain, tenderness, and any dryness or swelling. Then a simple and superficial massage (superficial stroke) is given for 2 minutes, which is a relaxation technique and will relax the foot and prepare for a specific reflexology treatment. First, a general reflexology will be used for 18 minutes on all reflex points in the sole of the foot and then 5 minutes of specialized reflexology. These points include the solar plexus, the pituitary gland, and the heart, each of which will be massaged with a thumb and constant pressure. The rest of the soles of the feet and some parts of the feet will be massaged continuously on the reflection points without interrupting contact with the skin, using the thumbs or other toes. The external side and sole of the foot will be massaged for one to two minutes each. The massage is performed under the toes with the movements of the thumb and in an arched shape from left to right for one to two minutes, which includes points related to the heart, lungs and chest. Then the rest of the time will be devoted to massaging the points related to the lumbar region in the arched part of the inner side of the foot. The index and middle fingers are used, which will be placed on the reflex points. The fingers will be far apart and close, and a movement similar to a tree worm will be performed on reflex points.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Low back pain score in McGill Pain Questionnaire" and "Numerical pain scale (10 cm line of pain)". Timepoint: Before the intervention, four months after the intervention. Method of measurement: The "McGill Pain Questionnaire" and the "Numerical Pain Scale (10 cm line)" will be used to "measure low back pain".</prim_outcome>
      <prim_outcome>"Mood status score in mood profile questionnaire". Timepoint: Before the intervention, four months after the intervention. Method of measurement: The mood profile questionnaire is used to assess mood.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-20</approval_date>
        <contact_name>Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medical Sciences (Research</contact_name>
        <contact_address>Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
