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IRCT20240609062051N1 IRCT 2024-06-16 Tehran University of Medical Sciences Investigating aromatherapy with the scent of roses in stress and anxiety in the treatment of infertility and pregnancy outcome The effect of the Rose Damascena aromatherapy on stress, anxiety and the outcome of conception in women candidate for Intracytoplasmic sperm injection (ICSI) 2024-06-22 anticipated 62 Complete https://irct.ir/trial/77274 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method is accessible and based on the study entry and exit criteria. In this way, after obtaining written consent from the samples, people are assigned to 2 intervention and control groups using block random allocation method and blocks of 4. Blocks are selected randomly and by placement.By using this method, it can be ensured that an equal number of participants will enter the experimental and control groups in consecutive time intervals. In order to prevent the possibility of the effect of the aroma spread in the air on the people of the studied groups, the department manager will be requested to place the studied samples in a separate room based on randomization and the same type of intervention received. For blocks of 4, six modes are considered as follows: 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC. N/A Condition 1: Stress and anxiety of women candidates for intracytoplasmic sperm injection at the stage of embryo injection. Condition 2: Pregnancy result two weeks after embryo injection and aromatherapy. Intervention 1: Intervention group: 1 hour before the injection of the embryo into the uterus, first fill the DAS 21 questionnaire and if the stress and anxiety were moderate or severe. Pour 3 drops of essential oil of 10 roses on a cotton ball in a zipped bag and ask the research unit in the intervention group to inhale for 10 minutes at a distance of 7 cm from his nose, and 1 hour later before the embryo injection, we measure the level of stress and anxiety with the DAS 21 questionnaire and with We compare before intervention. Intervention 2: Control group: 1 hour before the intrauterine injection of the fetus, first fill the DAS 21 questionnaire and if the stress and anxiety were moderate or severe. Pour 3 drops of distilled water on a cotton ball that is in a zippered bag and we ask the research unit in the control group to inhale for 10 minutes at a distance of 7 cm from his nose, and 1 hour later before the embryo injection, we measure the level of stress and anxiety with the DAS 21 questionnaire and before the intervention We compare. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the end of the research process, the decision is made under the supervision of scientific supervisors.
public Saeideh Baghaei Barjini
No 1. Mohajer Alley. Behboodi Street. Sattarkhan Street
Tehran Iran (Islamic Republic of) 1598116539 +98 21 7788 3283 S.baghaei03@gmail.com Khoram-Abad University of Medical Sciences scientific Dr. Mozhan masoudi
Kamalvand - Lorestan University of Medical Sciences
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3312 0165 masoudi.mozh@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Women with primary infertility aged 20 to 40 years Having at least 3 years of infertility history. Women with moderate and severe stress and anxiety based on the DASS21 questionnaire 20 years 40 years Female Use of perfume during operation Having a degree in psychology and participating in psychology sessions Allergy to herbal essential oils History of migraines and severe headaches Inhalation and smell disorders Suffering from severe mental and physical illnesses Occurrence of severe stressors in the last 6 months (death of first-degree relatives, driving accidents) The need to use other pharmacological and non-pharmacological methods to reduce stress and anxiety Addiction to tobacco, drugs and alcohol and the need to receive them F40.8 Other phobic anxiety disorders N/A N/A Intervention group: 1 hour before the injection of the embryo into the uterus, first fill the DAS 21 questionnaire and if the stress and anxiety were moderate or severe. Pour 3 drops of essential oil of 10 roses on a cotton ball in a zipped bag and ask the research unit in the intervention group to inhale for 10 minutes at a distance of 7 cm from his nose, and 1 hour later before the embryo injection, we measure the level of stress and anxiety with the DAS 21 questionnaire and with We compare before intervention. Control group: 1 hour before the intrauterine injection of the fetus, first fill the DAS 21 questionnaire and if the stress and anxiety were moderate or severe. Pour 3 drops of distilled water on a cotton ball that is in a zippered bag and we ask the research unit in the control group to inhale for 10 minutes at a distance of 7 cm from his nose, and 1 hour later before the embryo injection, we measure the level of stress and anxiety with the DAS 21 questionnaire and before the intervention We compare. The stress and anxiety score is based on the DASS 21 questionnaire, which is measured one hour before embryo injection and aromatherapy with the scent of roses or placebo and immediately before injection and after aromatherapy. Timepoint: Before and after aromatherapy with the scent of roses and placebo. Method of measurement: with DOSS 21 questionnaire. The result of pregnancy, which is measured by beta HCG two weeks after the injection of the embryo into the uterus. Timepoint: Two weeks after intrauterine embryo injection. Method of measurement: اندازه‌گیری مقدار بتا اچ سی جی در خون دو هفته بعد از تزریق جنین ورایحه درمانی است.The amount of beta HCG in the blood is measured two weeks after embryo injection and aromatherapy. Tehran University Approved 2024-05-21 Ethics Committee of Lorestan University of Medical Sciences Kamalvand Khorramabad Lorestan Iran (Islamic Republic of)