Protocol summary
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Study aim
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Determining The Effect of Inhalation Aromatherapy with Lemon Balm Essential Oil on Perceived Stress and Anxiety in Infertile Women Undergoing In Vitro Fertilization Treatment.
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Design
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This study is a clinical trial type with control and intervention groups, in parallel and without blinding, randomized, phase 1 on 88 patients. www.sealedenvelope.com was used for randomization.
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Settings and conduct
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The study site is Milad Infertility Center in Imam Reza Hospital in Mashhad. The research population includes all infertile women undergoing IVF treatment. Blinding was not done in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria included: having a history of infertility, undergoing in vitro fertilization treatment, having no history of mental health problems, having no smell problems, not using sedatives, opiates, and benzodiazepines, not being allergic to lemon balm, not having any physical illnesses, not having experienced any adverse events in the past 6 months, and using a type of ovulation stimulation treatment with gonadotropins.
Exclusion criteria: unwillingness to continue cooperation, allergy to lemon balm, failure to perform inhalation aromatherapy for two consecutive days, withdrawal from infertility treatment, occurrence of adverse events, change in health status that requires other treatments.
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Intervention groups
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In the aromatherapy intervention group, with the start of the in vitro fertilization hormone therapy cycle, 5-7 drops of lemon balm essential oil were dripped twice a day on a face mask for 2 weeks, and each time the mask was worn for 20-30 minutes while resting and in Calm conditions will be applied to the face and inhaled. In the control group, people will be given a placebo (almond oil). Questionnaires will be completed by both groups before the intervention and after the intervention.
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Main outcome variables
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Perceived Stress, Anxiety
General information
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Reason for update
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Changes in some parts
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240514061798N1
Registration date:
2024-06-03, 1403/03/14
Registration timing:
prospective
Last update:
2025-02-27, 1403/12/09
Update count:
3
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Registration date
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2024-06-03, 1403/03/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-06-21, 1403/04/01
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Expected recruitment end date
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2024-09-20, 1403/06/30
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Actual recruitment start date
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2024-07-15, 1403/04/25
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Actual recruitment end date
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2024-09-20, 1403/06/30
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Trial completion date
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2024-10-05, 1403/07/14
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Scientific title
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The Effect of Aromatherapy with Lemon Balm Essence on Perceived Stress and Anxiety in Infertile Women Undergoing IVF Treatment
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Public title
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The Effect of Aromatherapy on Perceived Stress and Anxietyin Infertile Women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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.
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Age
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From 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
88
Actual sample size reached:
86
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2024-05-14, 1403/02/25
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1403.015
Health conditions studied
1
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Description of health condition studied
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Infertile Women
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Perceived Stress
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Timepoint
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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).
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Method of measurement
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Fertility Problem Inventory (FPI)
2
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Description
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Anxiety
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Timepoint
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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.
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Method of measurement
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Anxiety Trait-State Inventory (STAI), Visual Analogue Scale.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All the data obtained from this research will be shared after the completion of the work.
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When the data will become available and for how long
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Access to the data will be possible 3 months after the results are published.
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To whom data/document is available
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These data will be used for researchers working in academic and scientific institutions, as well as for infertile women treated with assisted reproductive techniques.
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Under which criteria data/document could be used
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The data obtained from this research can be used in other scientific studies.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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