<?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>IRCT20240514061798N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-03</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Aromatherapy on Perceived Stress and Anxietyin Infertile Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Aromatherapy with Lemon Balm Essence on Perceived Stress and Anxiety in Infertile Women Undergoing IVF Treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Lemon balm plant is purchased from trusted centers of the Faculty of Iranian and Complementary Medicine. The plant was approved by a botanist at the Medicinal Plants Research Institute of Ferdowsi University and its herbarium code was announced. Then, using the traditional method in the laboratory of the Faculty of Iranian and Complementary Medicine, 160 grams of lemon balm plant was soaked in 1600 cc of sweet almond oil for 4 to 5 days, then filtered. To ensure that the oil was saturated with essential oil, 100 grams of fresh plant was soaked in the resulting oil for a second time for 4 to 5 days. Finally, it was filtered and standardized in the "Testa" quality control laboratory using gas chromatography(GC). The placebo was just odorless sweet almond oil, Randomization description: The Selection of Available Research Units will be Based on Inclusion criteria and Exclusion criteria. In order to Assign People to Intervention and Control groups, Permutation Block Method with Blocks of size 4 will be Used. For this Purpose, the Site www.sealedenvelope.com is Used. The Said Site will List The Number of 22 Blocks Randomly. This Method Continues Until all People are Assigned to Two Groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertile Women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Lemon Balm Plant is Purchased from Trusted Centers of the Faculty of Iranian and Complementary Medicine. The Plant will be Confirmed and its Herbarium Code will be Announced by a Botanist at Ferdowsi University Medicinal Plant Research Center. Then it is Kept in a Traditional way in The Laboratory of the Faculty of Iranian and Complementary Medicine, in the base of Sweet Almond Oil, for 4-5 Days, then It becomes Smooth. To Ensure that the Oil is Saturated with Essential Oil, the Fresh Plant is Soaked in The Resulting Oil for the Second Time for 4-5 Days. Finally, it will be Smoothed and Standardized by Gas Chromatography Method. Participating in this Group will use Lemon Balm Essential Oil for Aromatherapy. In this way, at the beginning of the IVF Hormone Treatment Cycle, 5-7 drops are Dripped on a Face Mask Twice a Day for 2 Weeks, and The Mask is Applied to the Face for 20-30 Minutes each time while Resting and in Calm Conditions. and Inhale it. Intervention 2: Control group: Participants in This Group will be given a Placebo to Perform Aromatherapy. In this way, at the beginning of the IVF Hormone Treatment Cycle, 5-7 drops are Dripped on a Face Mask Twice a Day for 2 Weeks, and The Mask is Applied to the Face for 20-30 Minutes each time while Resting and in Calm Conditions. and Inhale it. The Placebo will be Sweet Almond Oil only, which is Odorless.</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 the data obtained from this research will be shared after the completion of the work.

When:
Access to the data will be possible 3 months after the results are published.

To whom:
These data will be used for researchers working in academic and scientific institutions, as well as for infertile women treated with assisted reproductive techniques.

Conditions:
The data obtained from this research can be used in other scientific studies.

Where to obtain:
Copying (in any way) either from the full text or from extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the central library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing depends on citing the source in compliance with the Mashhad University of Medical Sciences publications.
Dr. Kobra Mirzakhani:

Narges Abdullahi Sanu:
na.midwifery@yahoo.com

How to obtain:
The applicant should send an email to the responsible author and register his request. After checking the accuracy of the information of the mentioned person, the required content will be provided to him with the reference of the source.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Educational Complex of Shahid Dr. Kharazmi, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Mirzakhanik@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Abdollahi Senu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Fallahi 38/15, Shahid Sanjrani Ave., Shahid Fallahi Blvd., Mashhad, Razavi Khorasan</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9186175859</zip>
        <telephone>+98 51 3623 3477</telephone>
        <email>AbdollahiSN4012@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a History of Infertility
Treated by In Vitro Fertilization (IVF)
No History of Psychological Problems
No Smell Problem
Not Using Sedatives, Narcotics and Benzodiazepines
Using a Type of Ovulation Stimulation Therapy with Gonadotropins
No physical illnesses
No experience of any unfortunate events in the past 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue collaborating in research
Allergy to Lemon Balm
Failure to perform inhalation aromatherapy for two consecutive days (four sessions)
Refusing to continue infertility treatment
Unfortunate events
A change in health status that requires other treatments.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Lemon Balm Plant is Purchased from Trusted Centers of the Faculty of Iranian and Complementary Medicine. The Plant will be Confirmed and its Herbarium Code will be Announced by a Botanist at Ferdowsi University Medicinal Plant Research Center. Then it is Kept in a Traditional way in The Laboratory of the Faculty of Iranian and Complementary Medicine, in the base of Sweet Almond Oil, for 4-5 Days, then It becomes Smooth. To Ensure that the Oil is Saturated with Essential Oil, the Fresh Plant is Soaked in The Resulting Oil for the Second Time for 4-5 Days. Finally, it will be Smoothed and Standardized by Gas Chromatography Method. Participating in this Group will use Lemon Balm Essential Oil for Aromatherapy. In this way, at the beginning of the IVF Hormone Treatment Cycle, 5-7 drops are Dripped on a Face Mask Twice a Day for 2 Weeks, and The Mask is Applied to the Face for 20-30 Minutes each time while Resting and in Calm Conditions. and Inhale it.</i_keyword>
      <i_keyword>Control group: Participants in This Group will be given a Placebo to Perform Aromatherapy. In this way, at the beginning of the IVF Hormone Treatment Cycle, 5-7 drops are Dripped on a Face Mask Twice a Day for 2 Weeks, and The Mask is Applied to the Face for 20-30 Minutes each time while Resting and in Calm Conditions. and Inhale it. The Placebo will be Sweet Almond Oil only, which is Odorless.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress. Timepoint: Measuring The Level of Perceived Stress will be Measured Initially Before the Start of The Intervention (The Start of The Hormone Therapy Cycle) and after The Completion of The Intervention (The End of The Hormone Therapy Cycle). Method of measurement: Fertility Problem Inventory (FPI).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Measuring The Level of Anxiety will be Measured Initially Before the Start of The Intervention (The Start of The Hormone Therapy Cycle) and after The Completion of The Intervention (The End of The Hormone Therapy Cycle). Also, The People Participating in The Intervention Group will be given a Self-Report Form for Measuring The Level of Anxiety with a Visual Analogue Scale of Ten Parts, which they will Complete every Night before going to Bed During The Intervention Period Since they Started Using Lemon Balm Essential Oil. Method of measurement: Anxiety Trait-State Inventory (STAI), Visual Analogue 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-14</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences</contact_name>
        <contact_address>Educational Complex of Shahid Dr. Kharazmi, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
