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IRCT20091021002618N3 IRCT 2023-10-14 Lorestan University of Medical Sciences Evaluation of the effect of Aromatherapy with Geranium on Anxiety and Labor pain Evaluation of the Effect of Aromatherapy with Geranium Essence on Anxiety and Labor pain in Nulliparous Women 2023-10-07 anticipated 100 Complete https://irct.ir/trial/71548 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method is accessible and based on the study entry 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. By using this method, it can be ensured that an equal number of participants enter the intervention and control groups in consecutive time intervals. Entry of people into each of the groups is done according to the number of selected blocks and the arrangement inside the block. 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, and the said blocks will be used approximately 4 times (24 people are allocated each time) so that the final sample size is allocated to two treatment and intervention groups: 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: This research will be double-blind in such a way that neither the researcher responsible for data entry into the software and data analysis nor the researcher (using a nose clip during the intervention) will be aware of the allocation of patients to the experimental or control group; Also, due to the possibility of the release of essential oil molecules in the environment, the release of pleasant odors (scented sprays) and sometimes the windows being open, we place the patients in separate LDR rooms and avoid opening the windows during the intervention; We also ask the hospital services to postpone the cleaning of the room, which is done using detergent solutions and may have an unpleasant smell, to before or after the intervention. The data will be collected by the researcher and the research assistant. N/A Anxiety and labor pain. Intervention 1: Intervention group: In the aromatherapy group, 2 drops (0.13 cc) of geranium essential oil are soaked in gauze and attached to the collar of the samples, and the administration will be repeated every 20 minutes. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm. Intervention 2: Control group: In the control group, 2 drops (0.13 cc) of distilled water are soaked in gauze and attached to the collar of the samples, and the administration will be repeated every 20 minutes. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm. 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 There is no further information.
public Soheila Pirdade Biranvand
Kamalvand
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3330 2033 kimia_n72@gmail.com Lorestan University of Medical Sciences scientific Soheila Pirdade Biranvand
Kamalvand
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3330 2033 kimia_n72@gmail.com Lorestan University of Medical Sciences Iran (Islamic Republic of) Iranian race and being a firstborn Single pregnancy with age 37 to 42 weeks Mother's age is 18-35 years Dilatation 4-5 cm at the beginning of labor Having at least 2-3 spontaneous uterine contractions lasting 40-45 seconds within 10 minutes The regularity of the fetal heartbeat with a number of 110-160 beats per minute The mother's vital signs are normal The number of fetal movements is normal according to the mother's report Body mass index 20-30 kg/m2 Height more than 145 cm The estimated weight of the fetus is 2500-4000 grams The fit of the fetal head with the mother's pelvis based on clinical examination Proportion of uterine height with gestational age in clinical examination 18 years 35 years Female Fetal distress or disruption of labor progress Existence of medical and midwifery problems in the current pregnancy Incidence of sensitivity to geranium essential oil in a person during the study The presence of olfactory disorders, allergies or previous unpleasant experiences with certain scents The use of painkillers or anti-anxiety drugs at least 3 hours before the intervention Addiction to tobacco, drugs and alcohol and the need to receive them The existence of any obstacle to perform natural childbirth The need to strengthen labor with oxytocin or other methods The need for an emergency caesarean section The need to use other medicinal and non-medicinal pain reduction methods Facing an important and unfortunate incident during the last week Treatment - Drugs Placebo Intervention group: In the aromatherapy group, 2 drops (0.13 cc) of geranium essential oil are soaked in gauze and attached to the collar of the samples, and the administration will be repeated every 20 minutes. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm. Control group: In the control group, 2 drops (0.13 cc) of distilled water are soaked in gauze and attached to the collar of the samples, and the administration will be repeated every 20 minutes. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm. Anxiety intensity score in Spielberger Anxiety Questionnaire. Timepoint: The intensity of anxiety will be measured before aromatherapy and in dilations of 4 to 5 and 8 to 10 cm. Method of measurement: Spielberger anxiety questionnaire. Labor pain intensity score on visual analog grade scale. Timepoint: Pain intensity will be measured before aromatherapy and at 4 to 5, 6 to 7 and 8 to 10 cm dilatations. Method of measurement: Visual analog degree scale. Lorestan University of Medical Sciences Approved 2023-05-24 Ethics Committee of Lorestan University of Medical Sciences Headquarters of Lorestan University of Medical Sciences, Anoushirvan Rezaei Square, Moalem St. Khorram abad Lorestan Iran (Islamic Republic of)