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IRCT20131009014957N8 IRCT 2019-12-04 Tabriz University of Medical Sciences Effect of aromatherapy and counseling based on mindfulness on sexual function, anxiety, and serum level of some bio-markers in postmenopausal women Effect of aromatherapy with essential oil of lavender-bergamot, and counseling based on mindfulness on sexual function, anxiety, and serum level of some bio-markers in postmenopausal women: A randomized controlled trial with factorial design. 2019-11-22 anticipated 132 Complete https://irct.ir/trial/41082 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Postmenopausal women aged 50-60 years will be divided into four groups of aromatherapy and routine care, counseling based on Mindfulness-Based Intervention (MBI) and aromatherapy, counseling based on MBI and placebo of aromatherapy, and control group (placebo of aromatherapy and routine care) using the RAS software with four and eight blocks with a 1: 1: 1: 1 allocation ratio and will be stratified based on menopausal years (less than or greater than 5 years). To conceal the allocated intervention, type of counseling intervention (counseling or routine care) will be written on papers and along with allocated aromas or placebo will be placed in the matte and sealed envelopes numbered from 1 to 132 based on random sequence generated by a non-researcher. The first envelope will be given to the first eligible person and will be continued until the completion of sampling. The participant, researcher and statistical analyst will not be aware of the contents of the package (allocation concealment). In this study, after the random allocation of the individual to the study group, the researcher and participant blindness would not be possible in terms of counseling,, Blinding description: In this study, outcome assessor and statistical analyst will be kept blind to the specific study groups. So that the combined aroma and its placebo will be poured into identical dark containers and identified only by random code of study. The outcome assessor and the statistical analyst will not be present at the consultation sessions. Questionnaires will not specify the type of intervention and only random code will be written. Also in the statistical software, only the code of the participants and the group number will be written. 3 Condition 1: Anxiety. Condition 2: Sexual dysfunction. Condition 3: Depression. Condition 4: Serum levels of some bio-markers. Condition 5: Menopausal symptoms. Condition 6: Sleep quality. Intervention 1: Intervention group 1: Mindfulness consulting along with placebo of aroma. Mindfulness in-person counseling will be held once per week for eight weeks through the 45-60 minute sessions in a native language. The number of participants in each meeting will be at least eight and up to twelve. The last 15 minutes will be devoted to question and answer. Aroma placebo (probylene glycol) will be rubbed 2 to 3 drops, 2-3 times a day for 8 weeks. The placebo will be made by Goldaru Pharmaceutical Company and packed in 30 ml dark glass. Intervention 2: Intervention group 2: ََAromatherapy with essential oil of lavender-bergamot along with routine care. Lavender-bergamot essential oil will be applied 3 times daily, 2-3 drops each time for 8 weeks on the forearm. The composition of the essential oils will be in the form of 5% lavender and 0.4% bergamot essential oils. The pure essential oils will be provided by the Goldaru Pharmaceutical Company. The analysis of essential oils, blending of them with the desired concentration will be carried out in the Faculty of Pharmacy and will be packed in 30 ml dark glass.Routine care will be carried out in accordance with the Ministry's approved protocol. Intervention 3: Intervention group 3: Aromatherapy with essential oil of lavender-bergamot along with Mindfulness consulting. Lavender-bergamot essential oil will be applied 3 times daily, 2-3 drops each time for 8 weeks on the forearm. The composition of the essential oils will be in the form of 5% lavender and 0.4% bergamot essential oils. The pure essential oils will be provided by the Goldaru Pharmaceutical Company. The analysis of essential oils, blending of them with the desired concentration will be carried out in the Faculty of Pharmacy and will be packed in 30 ml dark glass. Mindfulness in-person counseling will be held once per week for eight weeks through the 45-60 minute sessions in a native language. The number of participants in each meeting will be at least eight and up to twelve. The last 15 minutes will be devoted to question and answer. Intervention 4: Control group: Placebo of aroma along with routine care. Aroma placebo (probylene glycol) will be rubbed 2 to 3 drops, 2-3 times a day for 8 weeks. The placebo will be made by Goldaru Pharmaceutical Company and packed in 30 ml dark glass. Routine care will be carried out in accordance with the Ministry's approved protocol. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis). When: ُStarting immediately after publication To whom: Data will be available to researchers as well as to journals Conditions: The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking Where to obtain: Refer to the email address (farshbafa@tbzmed.ac.ir) How to obtain: The requests will be sent by email and data will be available within a week Comments:
public Dr. Azizeh Farshbaf-Khalili
Physical Medicine and Rehabilitation Research Center, Street, Ground Floor, Imam Reza Hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Azizeh Farshbaf-Khalili
Physical Medicine and Rehabilitation Research Center, Ground Floor, Imam Reza Hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Postmenopausal women between the ages of 50-60 Having read and write literacy The Female Sexual Function Score less than 28 Having mild to moderate anxiety based on Beck Anxiety Scale Having sex in the family limit with her permanent spouse Having only one wife for the man Natural menopause Obtaining a score of 15-42 on the Greene scale Having a score of 5 and higher in The Pittsburgh Sleep Quality Index (PSQI) 50 years 60 years Female Known physical and mental illnesses based on person's self statement (depression, diabetes, cardiovascular disease, olfactory sensations, mental disability, diabetes) Drugs affecting sex (sildenafil, antidepressants, antihistamines, diazepines, barbiturates, amphetamines, antihypertensive drugs, cocaine, thiazide diuretics, narcotics Use of herbal ingredients to increase sexual desire in men or women (ginseng, cinnamon, ginger, etc.) and alergy to any herbal medicine Addiction to the habitual consumption of alcohol and tobacco by women Participate in other similar studies Occurrence of an misadventure within 3 months prior of study (death or acute illness of close relatives) Disorder in the sense of smell according to person's self and other nasal disorders (fracture, aberration, rhinitis) Use of hormotherapy at last 6 month F41 F52 F32 N95 G47 Other anxiety disorders Sexual dysfunction not due to a substance or known physiological condition Major depressive disorder, single episode Menopausal and other perimenopausal disorders Sleep disorders Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group 1: Mindfulness consulting along with placebo of aroma. Mindfulness in-person counseling will be held once per week for eight weeks through the 45-60 minute sessions in a native language. The number of participants in each meeting will be at least eight and up to twelve. The last 15 minutes will be devoted to question and answer. Aroma placebo (probylene glycol) will be rubbed 2 to 3 drops, 2-3 times a day for 8 weeks. The placebo will be made by Goldaru Pharmaceutical Company and packed in 30 ml dark glass. Intervention group 2: ََAromatherapy with essential oil of lavender-bergamot along with routine care. Lavender-bergamot essential oil will be applied 3 times daily, 2-3 drops each time for 8 weeks on the forearm. The composition of the essential oils will be in the form of 5% lavender and 0.4% bergamot essential oils. The pure essential oils will be provided by the Goldaru Pharmaceutical Company. The analysis of essential oils, blending of them with the desired concentration will be carried out in the Faculty of Pharmacy and will be packed in 30 ml dark glass.Routine care will be carried out in accordance with the Ministry's approved protocol. Intervention group 3: Aromatherapy with essential oil of lavender-bergamot along with Mindfulness consulting. Lavender-bergamot essential oil will be applied 3 times daily, 2-3 drops each time for 8 weeks on the forearm. The composition of the essential oils will be in the form of 5% lavender and 0.4% bergamot essential oils. The pure essential oils will be provided by the Goldaru Pharmaceutical Company. The analysis of essential oils, blending of them with the desired concentration will be carried out in the Faculty of Pharmacy and will be packed in 30 ml dark glass. Mindfulness in-person counseling will be held once per week for eight weeks through the 45-60 minute sessions in a native language. The number of participants in each meeting will be at least eight and up to twelve. The last 15 minutes will be devoted to question and answer. Control group: Placebo of aroma along with routine care. Aroma placebo (probylene glycol) will be rubbed 2 to 3 drops, 2-3 times a day for 8 weeks. The placebo will be made by Goldaru Pharmaceutical Company and packed in 30 ml dark glass. Routine care will be carried out in accordance with the Ministry's approved protocol. Anxiety score in Beck Anxiety Inventory. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Beck Anxiety Inventory. Sexual function score in Female Sexual Function Index. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Female Sexual Function Index. Serum level of cortisol. Timepoint: At baseline and immediately after intervention. Method of measurement: Elisa method by ELISA kits. Depression score using Beck Depression Inventory. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory. Serum level of malondialdehyde. Timepoint: َAt baseline and immediately after intervention. Method of measurement: By spectrophotometric method based on reaction with thiobarbituric acid. Serum level of high-sensitivity C-Reactive Protein. Timepoint: َAt baseline and immediately after intervention. Method of measurement: Complex-based turbidometry based on the reaction between high-sensitivity C-Reactive Protein and specific antiserum. Serum level of Total Antioxidant Capacity. Timepoint: َAt baseline and immediately after intervention. Method of measurement: By Autoanalyzer Abbott (Alcyon 300) using Randox kit. Frequency of adverse events. Timepoint: While intervention. Method of measurement: Adverse events checklist. Menopausal symptom score using Greene climacteric scale. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Greene Climacteric Scale. The score of Pittsburgh Sleep Quality Index (PSQI). Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Tabriz University of Medical Sciences Approved 2019-10-14 Ethics Committee of Tabriz University of Medical Sciences Research Department., Third Floor., Central Construction Number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)